Achilles Tendon

Purpose of the study: tocompare the effect of early weight-bearing with that of non-weight-bearing on the early postoperative recovery following repair of an acutely ruptured Achilles tendon.

The study: 110 subjects with a surgically repaired Achilles tendon rupture from two tertiary care centers following two weeks of non-weight-bearing were randomly assigned to either continued non-weight-bearing or weight-bearing. The primary outcome measure was improvement using the Rand 36-Item health survey.

Results: at six weeks the weight-bearing group had significantly better scores using the primary outcome instrument. At six months there was no difference between either group relative to any outcome measured. Neither group experienced a rerupture of the tendon.

Study strengths:

• clear and concise description of randomization process as well as the method of concealment allocation

• explicit and appropriate description of sample size calculation

• fourteen orthopedic surgeons at two tertiary care centers participated in the trial

• complete and reproducible description of intervention

• primary outcome instrument patient oriented, validated and reference

• data of the primary outcome was analyzed as intention to treat

• baseline demographics were similar between the two groups

• results were presented for the primary outcome as a point estimate with 95% confidence intervals

Study limitations:

• lack of blinding specifically outcome assessors and analyst

Comments:

The study was well designed to limit bias and clearly reported. The results were precisely reported and easy to understand. The lower end of the 95% confidence interval for the primary outcome was below the clinically important effect used to calculate the sample size. This indicates that the study is not definitive. The ruptured tendon was repaired using various suture materials and techniques by 14 orthopedic surgeons in two different tertiary care centers. The intervention was reported sufficiently to allow for replication.

5/09

Shockwave Therapy for Chronic Achilles Tendinopathy

Rasmussen S., Christensen M , Mathiesen I, and Simonsen O.

Acta Orthopaedica 79: 249256, 2008.

_____________________________________________________

Purpose of the study: was to compare the effect of supplementing conservative treatment of chronic Achilles tendinopathy with ESWT .

The study: randomized, double-blind, placebo-controlled trial. The trial was conducted outpatient clinic at a University Hospital in Sweden. All subjects were given stretching exercises and eccentric training and were randomized to receive either active ESWT or sham ESWT over 4 weeks. American Orthopaedic Foot and Ankle Society (AOFAS) scores and pain (VAS) were assessed before treatment, during the 4-week treatment period, and at 4, 8, and 12 weeks of follow-up.

Results: both groups improved during the treatment and follow-up period. The mean AOFAS score increased from 74 (12) to 81 (16) in the placebo group and from 70 (6.8) to 88 (10) in the intervention group (p = 0.05). Better results were seen in the intervention group at 8 and 12 weeks of follow-up (p = 0.01 and p = 0.04, respectively).

Authors conclusions: extracorporal shock-wave therapy appears to be a supplement for the treatment of chronic Achilles tendinopathy.

__________________________________________________________________________________________________________

Study strengths:

• blinding included participants, investigator using ESWT and the evaluator of the outcome. Clear and convincing description of blinding process for participants.

• demographics of participants at stary of the study were similar

• clear sample size description was provided for the AOFAS instrument

• adequate description of randomization process

• concealment allocation process described as sequential sealed opaque envelopes

• trial registry disclosed

• data was analyzed on an intention to treat basis and participants lost to follow-up were minimal

Study Weaknesses:

• the AOFAS hindfoot scale was used as the primary outcome instrument, it is unlikely that this is a patient oriented instrument

• it was unclear as to what the minimum important difference was, no references were provided for the minimum important difference for the primary outcome instrument

• the presentation of the results in terms of point estimates and 95% confidence intervals for the primary outcome instrument would help in understanding the study

• unable to find study in clinical trials.gov using information provided in the article

Comments:

The use of the AOFAS instrument as the primary outcome is not consistent with a patient oriented measure. The change in the AOFAS score between the groups at four weeks was not statistically significant. A statistically significant effect was found at 8 and 12 weeks favoring the intervention group. It was difficult to determine if this change was clinically significant given information in the article. The study lasted 4 weeks.

The authors chose to use a visual analogue scale to measure pain as a secondary outcome. This would've been more appropriate as a primary outcome since it is patient oriented. There was not a statistically significant difference using the visual analogue scale at any time period. Point estimates and 95% confidence intervals were not reported & would've been helpful to determine if there was a clinically important difference that may have been missed. It was unclear if the study was adequately powered to detect a difference using the visual analog scale.

It was unclear how many subjects had bilateral symptoms, and whether the symptoms were at the insertion of the Achilles' tendon or above its insertion.

The results of the study do not seem to support the authors conclusion.

4/09

Nonoperative Treatment of Midportion Achilles Tendinopathy

Magnussen R., et.al. Clin J Sport Med Volume 19: 54, 2009.

_________________________________________________________________________________________________________

Purpose of the study: provide a summary of the best available evidence for nonoperative treatment of midportion Achilles tendinopathy

The Study: Systematic Review

Results: sixteen randomized controlled trials comparing non-operative treatment of Achilles tendinopathy were found which had a primary outcome measure change in numeric pain score

Authors Conclusion: eccentric exercises have the most evidence of effectiveness in the treatment of midportion Achilles tendinopathy

__________________________________________________________________________________________________________

Study Strengths:

• clear focused foreground study question
• inclusion and exclusion criteria consistent with study question
• multiple databases to include the Cochrane Collaboration were searched as were the references from the selected papers, search terms were included
• clear and thorough presentation of articles selected in table format with adequate information

Study weaknesses:

• the search only included English-language papers
• it was not clear if the following areas were searched for references trial registries, experts in the field, proceedings of meetings and conferences and professional organizations
• there was incomplete information regarding article acquisition and data abstraction, who did what?
• was study quality evaluated?

Comments:

It would've been helpful if the authors presented more information about article acquisition and data abstraction. Some information about study quality as the authors saw it would've been helpful. Presentation of results from articles included in the study was clear and helpful to the reader in understanding this topic. Discussion and conclusions seem to be consistent with the proposed foreground question and information found.

1/09

ANKLE

A Randomized Controlled Trial of a Removable Brace Versus Casting in Children with Low Risk Ankle Fractures.

Boutis K., Willan A., Babyn P., et. al. Pediatrics, 119: 1256-1263, 2007.

__________________________________________________________________________________________________________

Purpose of the study: to determine if children with low risk lateral ankle fractures can be safely treated with a removable brace rather than a below the knee cast.

The study: a randomized controlled trial of 111 children presenting to an emergency department with traumatically induced lateral ankle pain diagnosed as a low risk fracture received either a below the knee walking cast or a removable ankle brace. Subjects were evaluated in four weeks for improvement.

Results: the results of the primary outcome revealed that children treated with a removable ankle brace had statistically and clinically significant improvement over children treated with a below the knee walking cast.

Authors conclusions: treatment of low risk ankle fractures in children with a removable brace is superior and less costly than conventional treatment consisting of a below the knee walking cast.

_________________________________________________________________________________________________________
Study strengths:

clear and thorough description of what constitutes a low risk lateral ankle fracture
randomization and concealment allocation process was distinctly described, and the concealment allocation process consisted of contacting an internet site prior to randomization
assessment was performed by a blinded physiotherapist four weeks after treatment started
the authors used a single primary outcome instrument
the data was analyzed on an intention to treat principle
statistical tests to analyze the data collected were clearly described in the methods section and the tests are commonly used in the medical literature
there was a explicit discussion of how the sample size was calculated
of the 111 subjects randomized in the study seven were lost to follow-up
the two groups were similar at a baseline
point estimates of the primary outcome were reported with 95% confidence interval

Study weaknesses:

the primary outcome instrument was modified to include an additional eight questions related to ankle activity in consultation with the author of the instrument after it was validated

Comments:

This was a well planned and executed study. While it is common for most randomized controlled trials to report statistically significant results, this is one of the few that distinctly report clinically relevant results as well(1). It is likely that most podiatry practices have in their office some type of ankle brace commonly used in treating ankle sprains. While low risk ankle fractures in children may not be common in clinical practice, it is sobering to note that they may be effectively treated with something as simple as an ankle brace as described in the article.

The difference between the point estimate of the two treatment arms was 6% in favor of the brace; however the lower boundary of the 95 % confidence interval was 1.13% . Therefore, the study can be considered positive but not definitive with respect to clinical relevance.

(1) Chan K., Man-Son-Hing M, et. al. How well is the clinical importance of study results reported? An assessment of randomized controlled trials. CMAJ, 165: 1197-1202, 2001.

Rev 1/08

Accuracy of Ottawa ankle rules to exclude fractures of the ankle and midfoot: systematic review

Bachmann L, Kolb E, Koller M, Steurer J, ter Riet G. BMJ 326: 417, 2003.

__________________________________________________________________________________________________________

Purpose of the study: to summarise the evidence on accuracy of the Ottawa ankle rules

The study: systematic review. Data were extracted on the study population, the type of Ottawa ankle rules used, and methods. Sensitivities, but not specificities, were pooled using the bootstrap after inspection of the receiver operating characteristics plot. Negative likelihood ratios were pooled for several subgroups, correcting for four main methodological threats to validity.

Results: The pooled negative likelihood ratios for the ankle and midfoot were 0.08 (95% confidence interval 0.03 to 0.18) and 0.08 (0.03 to 0.20), respectively. The pooled negative likelihood ratio for both regions in children was 0.07 (0.03 to 0.18). Applying these ratios to a 15% prevalence of fracture gave a less than 1.4% probability of actual fracture in these subgroups.

Authors conclusion: Evidence supports the Ottawa ankle rules as an accurate instrument for excluding fractures of the ankle and midfoot. The instrument has a sensitivity of almost 100%.

__________________________________________________________________________________________________________

Study strengths:

• reasonable study question

• acceptable database search, no language restrictions, no mention if experts consulted

• clear and appropriate description of inclusion criteria

• clear and appropriate description of article validity evaluation

• adequate information provided regarding the articles abstracted for the study

• reviewers present a table of pooled negative likelihood ratios based on subgroups of increasing complexity of a methodological quality

• 2 reviewers were used to select, evaluate, and abstract data. disagreements resolved by consensus

• a ROC curve was presented

• since the Ottowa foot and ankle rules are calibrated towards high sensitivity only the sensitivity and negative likelihood ratios were pooled using a random effects model

• heterogeneity was expressed in terms of subgroup analysis

• results were presented as point estimates with 95% confidence intervals

Study Weaknesses:

A forest and funnel plot of the studies included would have been helpful for the reader to interpret the data abstracted from the studies

Comments:

Thoughtful well reported study which demonstrates that the Ottawa foot and ankle rules are highly accurate for excluding fracture after clinical examination for lateral ankle sprain.

7/09

Purpose of the study: To evaluate the effectiveness of an unsupervised proprioceptive training program on recurrences of ankle sprain after usual care in athletes who had sustained an acute sports related injury to the lateral ankle ligament.

The study: a randomized controlled trial of 522 athletes in a primary care setting were followed for one year post injury. The intervention group received a home-based proprioceptive training program. The main outcome measure was self-reported recurrence of a lateral ankle sprain.

Results: 56 (22%) of the intervention group reported a re occurrence of the lateral ankle sprain while 89 (33%) of the control group reported a recurrence. Nine participants needed to be treated with the intervention to prevent one recurrence (NNT).

Strengths:

• trial registered ISTRCN34177180

• randomization was carried out by statistician not involved in the study

• description of intervention process with references allows for replication

• primary outcome clinically relevant to athlete

• description of sample size calculation

• the authors define a clinically important effect as a reduction in recurrent ankle sprains by 50%

• blinding of data collectors

• groups are comparable baseline

• analysis of the data was carried out on an intention to treat principle

• the primary outcome was reported as a point estimate with 95% confidence intervals

• the range of athletes enrolled in the study

Weaknesses:

• lack of description of randomization process and concealment allocation process

• sample size calculation estimated 680 athletes needed to be enrolled however, 522 were enrolled

• although there was a statistically significant difference favoring the intervention group the reduction of recurrent sprains did not exceed 50%

• although the authors stated that the data would be analyzed on intention to treat basis the numbers of participants analyzed were less than the number of participants randomized

Comments:

The results of the study appear to substantiate the authors conclusion that a home-based proprioceptive unsupervised rehabilitation program reduces the number of recurrent lateral ankle sprains. An unsupervised home-based proprioceptive training program post initial treatment for an acute lateral ankle sprain appears feasible for the general podiatric physician to perform given the description in the article and references in the study. Although the study appears to exhibit good external validity for athletes residing in the Netherlands the podiatric physician will have to judge the generalizability of the findings to their own personal practice situation.

8/09

CAVUS FOOT

Effective Orthotic Therapy for the Painful Cavus Foot

Burns J., Crosby J., Ouvier R., Hunt A. JAPMA 96: 205, 2006.

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Purpose of the study: the effectiveness of custom foot orthoses on foot pain and function was investigated.

The study: patients with painful cavus feet were randomized into two groups one group receiving a custom foot orthotic device the control group receiving a sham device. Using a Foot Health Status Questionnaire patients were evaluated at baseline and again at three months for improvement.

Results: foot pain and function scores improved more with custom foot orthoses than the control.

Authors conclusion: custom foot orthosis are more effective than a control for the treatment of cavus foot pain and function.

__________________________________________________________________________________________________________

Study strengths

• distinct explanation of eligibility and exclusionary criteria

• clear definition of cavus foot deformity with reference

• adequate explanation of how patients were casted for foot orthosis and how foot orthosis were fabricated

• primary outcome instrument patient-oriented clearly described and referenced

• satisfactory explanation of how sample size was calculated

• clinically important difference was defined between groups as 10 points using the Foot Health Status Questionnaire scores

• appropriate and thorough explanation of randomization and concealment allocation process

• participants were blinded; assessor bias was minimized by having patient self-report to research assistant blinded to allocation

• statistical analysis for primary outcome uncommon but appropriate and well referenced

• subjects were similar at baseline

• results reported as point estimate with 95% confidence intervals

• data analyzed by intention-to-treat analysis

• only one patient lost to follow-up

Comments

It is always difficult to generalize studies evaluating customize foot orthoses due to the method of obtaining a negative foot impression and how the device was fabricated may vary from the readers practice. Changes in the manner foot impressions are obtained, and the way the prescriptions are written may affect the function of the device produced.

This was a carefully planned, executed and reported study. The author reported evidence of a moderate effect for custom foot orthosis on foot pain and function in participants with cavus foot type.

However, the point estimates for the primary outcome was less than the minimal clinically significant difference even though it was statistically significant. The upper confidence level was greater than the minimally important clinical difference therefore, enrolling a larger patient population may be required to demonstrate a clinically important difference.

3/08

Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial

S E Lamb, J L Marsh, J L Hutton, R Nakash and M W Cooke. Lancet 373: 575,2009.

__________________________________________________________________________________________________________

Purpose of the Study: to compare the effectiveness of three types of mechanical support with that of tubular compression bandage in promoting recovery of function after an acute, severe ankle sprain.

The Study:pragmatic, multicentre randomised trial with blinded assessment of outcome.584 participants were recruited from emergency room's across the United Kingdom. The primary outcome was quality of ankle function at three months.

Results: Aircast brace and below the knee cast both demonstrated improvement at three months in terms of function relative to tubular compression bandages however, only the below the knee cast demonstrated improvement in secondary outcomes (pain, symptoms, activity). Bledsoe boots offered no evidence of improvement over tubular compression dressings.

Author's conclusions:A short period of immobilisation in a below-knee cast or Aircast results in faster recovery than if the patient is only given tubular compression bandage. We recommend below-knee casts because they show the widest range of benefit.

___________________________________________________________________________________________________________________________

Study strengths:

• the trial was registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450

• funding and conflict of interest reported by authors

• clear and concise description of inclusion and exclusion criteria

• clear description of interventions with references

• comprehensive description of third-party randomization and off-site concealment allocation process

• data entry researchers were blinded to the treatment allocation

• the primary outcome instrument appears to be a patient oriented measure which is likely to have been validated however, the authors do not explicitly state this in the methods section

• a thorough description of the sample size calculation was given to ensure enough participants were enrolled to detect a clinically important difference in all outcomes

• the data were interpreted as intention to treat with an explanation provided

• the authors sought to collect data on additional treatments other than the intervention

• all participants seem to be similar baseline for known prognostic factors

• results are reported as point estimates with 95% confidence intervals and effect sizes

• results of adverse effects and additional therapies are reported

Comments:

This appears to be a well designed, implemented and reported trial offering clear and believable advice with regards to the treatment of severe lateral ankle sprains. Additional commentary regarding this article can be found in the same issue of the Lancet ⁽¹⁾

1Jay Hertel. Immobilization for acute severe ankle sprain. Lancet 373:524, 2009.

2/2009

DIABETIC FOOT

Does This Patient With Diabetes Have Large-Fiber Peripheral Neuropathy?

Jamil N. Kanji; Rebecca E. S. Anglin; Dereck L. Hunt; et al. JAMA.303:1526, 2010.

Purpose of the study: To systematically review the literature to determine the clinical examination findings predictive of asymptomatic LFPN before foot ulceration develops.

The study: MEDLINE (January 1966November 2009) and EMBASE (1980-2009 [week 50]) databases were searched for articles on bedside diagnosis of diabetic peripheral neuropathy. Included studies compared elements of history or physical examination with nerve conduction testing as the reference standard.

Results: The most useful examination findings were vibration perception with a 128-Hz tuning fork (LR range, 16- 35) and pressure sensation with a 5.07 Semmes-Weinstein monofilament (LR range, 11-16). Normal results on vibration testing (LR range, 0.33-0.51) or monofilament (LR range, 0.09-0.54) make LFPN less likely. Combinations of signs did not perform better than these 2 individual findings.

Authors conclusions: Physical examination is most useful in evaluating for LFPN in patients with diabetes. Abnormal results on monofilament testing and vibratory perception (alone or in combination with the appearance of the feet, ulceration, and ankle reflexes) are the most helpful signs.

Study strengths:

• the study is started with a clear foreground question

• unambiguous inclusion / exclusion criteria described and appear appropriate for study

• search strategy described

• interrater agreement regarding article selection between authors reported

• prior probabilities reported

• test accuracy reported as likelihood ratios with 95% CI

• agreement between investigators reported as kappa statistic

Study weakness:

• search of two common databases / limited to English language / consult with experts

• the description of the article acquisition and data abstraction could have been more complete in the methods section limited mostly to author contributions section at end of article

• the authors evaluated for study quality but did not clearly describe the method used

Comments:

The authors provide an informative systematic review of the workup of large fiber disease in the diabetic foot population. More transparency and explanation of the evaluation of study quality, article acquisition and data abstraction would be helpful in evaluating the quality of the review.

5/10

Randomized trial of custom orthoses and footwear, on foot pain and plantar pressure in diabetic peripheral arterial disease.

Purpose of the study: the trial was performed to assess the efficacy of custom foot orthoses on foot pain and plantar pressure in diabetic patients with peripheral arterial disease.

The study: 61 subjects were randomized to two groups custom foot orthoses or sham inserts. Both groups received standardized walking footwear. The primary outcome was The Foot Health Status Questionnaire which was measured at baseline and eight weeks post treatment.

Results: Custom foot orthoses significantly reduced plantar pressure compared with the sham, but there were nosignificant differences between groups for pain or function. The high-quality walking footwear provided to both groups may explain this finding.

Study strengths:

• registration of the trial
• description of randomization sequence and allocation process
• description of process used for blinding participants
• analysis of data by intention to treat process
• use of validated reliable patient oriented primary outcome instrument
• calculation of sample size
• presentation of baseline characteristics of subjects
• presentation of data as point estimates with 95% confidence intervals

Study weaknesses:

none

Comments:

As with any study of customized foot orthoses it is difficult to generalize the findings to individuals practice unless the method of obtaining the negative impression and the method of fabricating the custom device are similar to the readers practice. Would a clinically important difference still be able to be detected for the primary outcome if additional patients were enrolled in the study?

10/09

Preventing Foot Ulcer Recurrence in High Risk Patients

Lavery L., Higgins K., et al.. Diabetes Care, 30:14-20, 2007

__________________________________________________________________________________________________________

Purpose of the study: to evaluate whether home monitoring of skin temperature and subsequent behavior modification in diabetics with a prior history of foot ulceration and without severe peripheral vascular disease reduces the occurrence of foot ulcers

The study: one hundred seventy three diabetic patients at multiple sites were randomized to one of three groups and followed for fifteen months. In the experimental group, subjects were asked to monitor their pedal skin temperature daily using an infrared skin thermometer and if elevated contact the study nurse and reduce activities until skin temperatures normalized.

Results: subjects in the experimental group who monitored their skin temperatures had less reoccurrence of foot ulcers (statistically significant) than the other two groups. The results are reported as odds ratios with 95% confidence intervals.

Authors conclusions: infrared home monitoring of skin temperature was useful in preventing diabetic foot ulcers in high risk diabetic patients

___________________________________________________________________________________________________________

Study strengths:

the method of randomization and concealment allocation were appropriate and explicitly described
the primary outcome was occurrence of foot ulceration which was clearly reference by the authors
straightforward and adequate explanation of training provided the experimental group re the skin temperature monitoring device
sample size was calculated prior to the study and enough patients were randomized into each arm of the study to be consistent with the calculation
the data was analyzed using statistical tests common to the medical literature and consistent with the data collected
subjects were comparable at baseline in all three groups
data was analyzed by an intention to treat principle
all three groups were similar at baseline
the primary outcome is reported as an odds ratio with 95% confidence intervals, the lower range is above 1

Study weaknesses:

this was a single blinded study as the subjects were asked not to divulge their treatment allocation to their treating podiatrist, who determined the primary outcome. How effective the method was is left to the reader.

Disclosures:

Some of the authors hold stock in Silas Medical and Dr. Lavery is a member of the Board of Directors. Silas Medical manufactured the temperature monitoring instrument used in the study.

Comments:

This is a well designed and well executed study whose results and recommendations should be embraced by anyone who treats high risk diabetic patients. Sometimes odds ratios may be difficult for clinicians to interpret. In studies reporting dichotomous outcomes treatment effects maybe better understood by looking at the number needed to treat. Based upon the data provided in the study, the number of patients needed to treat ( NNT) to prevent one case of ulceration using the skin temperature monitoring device is 5. (1)

It would have been interesting to find out what percentage of patients using the skin temperature monitoring device were able to use it without assistance from family members. In addition, it would have been interesting to know a little bit more about what happened when skin temperatures were elevated, for example, which activities were restricted, or how long was it necessary to restrict activities.

Foot care specialists should avoid generalizing the results to the entire diabetic population.

(1) Cook R J, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect.BMJ, 310:452, 195.

Rev 1/08

Magnetic Resonance Imaging for Diagnosing Foot Osteomyelitis. A meta-analysis

Kapoor A., Page S., LaValley M., Gale D., Felson D. Arch Intern Med 167:125, 2007.

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Purpose of Study: a meta-analysis was conducted to determine the diagnostic test performance of magnetic resonance imaging for osteomyelitis of the foot and compared this performance with that of technetium bone scanning, plain film radiography, and white blood cell studies.

The study: databases were searched from 1980 through 2006 for English-language studies in which adults suspected of having osteomyelitis of the foot or ankle were evaluated by MRI. Data was then extracted using a standardized form derived from the Cochrane Methods Group. To summarize the performance of diagnostic tests, the authors used the summary receiver operating characteristic curve analysis.

Results: 16 studies met inclusion criteria. In all studies combined, the DOR for MRI was 42.1 (14.8-119.9), and the specificity at a 90% sensitivity cut point was 82.5%. The DOR did not vary greatly among subsets of studies. In studies in which a direct comparison could be made with other technologies, the DOR for MRI was consistently better than bone scanning, plain radiography, and white blood cell studies.

Authors conclusions: the authors found that MRI performed well in the diagnosis of osteomyelitis of the foot and ankle and can be used to rule in or out the diagnosis. Magnetic resonance imaging performance was markedly superior to that of bone scanning, plain film radiography, and white blood cell studies.

_________________________________________________________________________________________________________

Study strengths:

• distinct and appropriate explanation of the search strategy to include database, bibliography of included studies, and specialists within the field. Additional information from authors upon request.

• explicit description of inclusion criteria used to select the articles for the study.

• appropriate description and reference of checklist used to evaluate the internal validity of the studies selected.

• two independent reviewers extracted the data, a third author refereed ties.

• precise and very appropriate description of information extracted from the studies used in the meta-analysis

• transparent description of how the data synthesis and analysis was performed.

• a nominal description of the meta-analytic method of analysis was described but well referenced.

• clear flowchart of the article selection was included.

• a table was included listing the characteristics of the included studies. The table included the source, enrollment criteria, number of patients in each study, mean age of patients, prevalence of diabetes, type of design, consecutive enrollment, blinding of assessors.

• a table was included showing the diagnostic performance of the technologies used in the study.

• a figure was included showing the summary receiver operating characteristic curve of MRI performance.

• a clinically relevant cut point was described for MRI

• a table and figures were used to illustrate the head-to-head comparison of MRI and other imaging modalities

Study weaknesses:

• the study search only included English-language articles.

• the methods and results of the authors search for heterogeneity were unclear

Comments:

The study was well planned, carefully executed and thoroughly reported. The biggest problem with the study was the quality of the primary studies used. The authors describe in detail deficiencies in the primary research in the comments section.

The authors provide a pretest probability for osteomyelitis derived from studies used in the meta-analysis and illustrate the application of the likelihood ratios for MRI derived from the study in calculating a posttest probability for osteomyelitis.

Due to the quality of the studies the treatment effect may be overestimated.

2/08

Risk Factors for Foot Infections in Individuals With Diabetes

Lavery L, et. al. Diabetes Care: 29, 1288, 2006.

__________________________________________________________________________________________________________

Purpose of the Study:

to determine risk factors for foot infection in a diabetic cohort.

The Study:

prospective study of 1,666 diabetic patients enrolled over an eight month period, patients were followed an average of 27 months, (3.9-32) months

Results:

151 patients developed 199 foot infections, 19.9% developed a bone infection. Patients who developed foot infections had a significantly higher risk of hospitalization, and amputation. Multivariate analysis revealed independent risk factors for infection to be wounds which penetrated to bone, wounds with a duration of more than 30 days, recurrent wounds, and the presence of peripheral vascular disease.

Authors conclusions:

foot infections occur relatively frequently in the diabetic population. When they do the risk of hospitalization and amputation increase significantly. Efforts to prevent infections should be targeted to diabetic patients with chronic, deep, traumatic foot wounds,which are associated with peripheral vascular disease.

_________________________________________________________________________________________________________

Study strengths:

• prospective cohort study

• detailed description of initial evaluation of participants as they entered the study

• number of patients enrolled in the study

• average length of follow-up

• detailed description of how infection was diagnosed references included

• well described description of commonly used statistical methods used to determine effects of predictor variables on the primary outcome infection

• results of statistical analysis presented as odds ratios with 95% confidence intervals

Study Weaknesses:

• it was unclear as to how and by whom the primary outcome was diagnosed, review of claims data for hospitalizations and amputations as well as, evaluation clinically by one of the authors during a follow-up visit?

• it was not clear how many patients were lost to follow-up

Comments:

The study was conducted from two large primary care physician groups in Texas. The authors claim that this is the first prospective study of risk factors for diabetic foot infections. This study should be of interest to anyone who treats diabetic foot problems.

4/08

A Systematic Review of the Effectiveness of Negative Pressure Wound Therapy in the Management of Diabetes Foot Ulcers.

Bell G., and Forbes A. Int Wound J 5: 233, 2008.

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Purpose of the Study: to evaluate the effectiveness of negative pressure wound therapy.

The Study: a systematic literature review and a tabulative synthesis of randomized controlled trials on this subject was performed. The primary outcome of this study was the number of patients achieving complete wound healing.

Results of the Study: the review identified four randomized controlled trials of weak to moderate quality. Only one study examining post amputation wound healing reported data on the primary outcome.

Authors Conclusion: there is a strong need for larger trials to assess NWPT in diabetic patients.

_________________________________________________________________________________________________________

Study Strengths:

• review question is well focused

• multiple databases were searched, search string defined, secondary references were found as result of citation search, hand searches of several journals were undertaken, advice sought from experts.

• primary outcome described

• articles selected independently by two reviewers, inclusion criteria discussed, differences resolved through consensus

• data extraction independently by two authors, type of data to be extracted described in article

• due to the small number of studies and heterogeneity of designs statistical meta-analysis was inappropriate

• description of how quality assessment of articles was accomplished

• table included summarizing the studies provided an article

Study weaknesses:

• it was unclear during the search strategy whether non-english language articles were included in the study, were device manufacturers consulted for additional references?

• under the description of quality assessment much was made about description and evaluation of diabetic wounds; how important this was and whether it should be included in a study whose primary outcome was complete wound healing remains questionable

• the description of heterogeneity of the studies was brief more information would be helpful

Comments:

Any systematic review/meta-analysis is limited in its validity by the quality of the studies it finds. NWPT may be used in different manners by different practitioners in affecting wound healing. Not all wounds may be closed primarily with NWPT but merely to provide a quality granulating bed which can be grafted or secondarily closed. Your particular circumstances regarding NWPT may affect the external validity of this article.

7/08

Diagnostic Accuracy of the Physical Examination and Imaging Tests for Osteomyelitis Underlying Diabetic Foot Ulcers: Meta-Analysis

Dinh M., Abad C., and Safdar N. Clinical Infectious Diseases 47:0, 2008.

_________________________________________________________________________________________________________

Purpose of the study: the authorsundertook a meta-analysis of the accuracy of diagnostic tests for osteomyelitis in diabetic patients with foot ulcers.

The study:Pooled sensitivity and specificity, the summary measure of accuracy (Q*), and diagnostic odds ratio were calculated from the selected studies.

Results:Exposed bone or probe-to-bone test had a sensitivity of 0.60 and a specificity of 0.91. Plain radiography had a sensitivity of 0.54 and a specificity of 0.68. MRI had a sensitivity of 0.90 and a specificity of 0.79. Bone scan was found to have a sensitivity of 0.81 and a specificity of 0.28. Leukocyte scan was found to have a sensitivity of 0.74 and a specificity of 0.68. The diagnostic odds ratios for clinical examination, radiography, MRI, bone scan, and leukocyte scan were 49.45, 2.84, 24.36, 2.10, and 10.07, respectively. The presence of exposed bone or a positive probe-to-bone test result is moderately predictive of osteomyelitis.

Authors conclusions:MRI is the most accurate imaging test for diagnosis of osteomyelitis.

___________________________________________________________________________________________________________

Study strengths:

• clear description of search strategy and search string

• clear description of inclusion and exclusionary criteria, gold standard of bone biopsy histopathologic characteristics was used as criteria for inclusion

• method used to evaluate study quality described and referenced

• restricted selection of studies to those which included referenced tests and diagnostic test on entire study population

• sensitivity and specificity were abstracted from each article pooled and tested for heterogeneity

• positive and negative likelihood ratios and pooled diagnostic odds ratios were calculated

• a summary measure of accuracy (Q*) was also calculated

• individual study characteristics included

• Cochrane's Q statistic was used as a test for heterogeneity

• a random effects model was used to pool all the data

• discussion of use of laboratory tests (ESR) used to diagnose osteomyelitis

Study Weaknesses:

• only 2 databases were searched, only English-language articles were considered, no contact with experts in the field

• unclear if more than one author abstracted the information from the articles

• two studies were found evaluating clinical impression and presence of osteomyelitis, results from two probe to bone tests were combined

• a forest plot of the data would have been helpful for the reader

• limited discussion of heterogeneity and how it influenced the study

Comments:

The results of the study are similar to an earlier study reviewed ⁽¹⁾ showing MRI was the best test to evaluate osteomyelitis in a diabetic foot. The DOR for MRI was lower in this study because the authors were more selective in their criteria for study inclusion than the earlier meta-analysis. Only two studies were pooled to evaluate probe to bone, 4 more studies were used to evaluate the other diagnostic tests. Pretest probabilities for osteomyelitis ranged from 12-89%. The companion editorial in the same issue should be reviewed ⁽²⁾

1.Magnetic Resonance Imaging for Diagnosing Foot Osteomyelitis. A meta-analysis Kapoor A., Page S., LaValley M., Gale D., Felson D. Arch Intern Med 167:125, 2007.

2.Bone of Contention: Diagnosing Diabetic Foot Osteomyelitis.Lipsky B. Clinical Infectious Disease 47: 2008

Negative pressure wound therapy a vacuum of evidence?

Gregor S.et. al. Arch Surg 143: 189, 2008.

_________________________________________________________________________________________________________

Purpose of the Study: to systematically examine the clinical effectiveness and safety of negative pressure wound therapy compared with conventional wound therapy.

The study: multiple databases were searched to include the Cochrane Library, manufacturers were contacted and trial registries were screened for relevant articles. Randomized controlled trials and non-RCTs were included with the main outcome of interest being wound healing variables.

The results: seven randomized controlled trials and ten non-randomized controlled trials met inclusion criteria. The overall methodologic quality of the trials was poor. Significant differences in favor of NPWT for time to wound closure or incidence of wound closure were shown in two of five RCTs and two of four non-RCTs . A meta-analysis of changes in wound size that included for RCTs and to non-RCTs favored NPWT .

The author's conclusions: although there is some indication that NWPT may improve wound healing, the body of evidence available is insufficient to clearly prove an additional clinical benefit of NPWT. The large number of prematurely terminated and unpublished trials is reason for concern.

__________________________________________________________________________________________________________

Study strengths:

• search strategy clearly described to include multiple databases, trial registries, FDA device manufacturers, experts in the field and other health agencies were contacted for published and unpublished data. Further information can be obtained at a referenced web site.

• all languages were included

• all abstracts were screened independently by two reviewers

• all retrieved full-text articles were independently examined by five reviewers

• trial quality was assessed using standardized methods which were referenced

• industry sponsorship for each study was determined

• data was extracted using a standardized form and summarize independently by two reviewers

• the authors were contacted to clarify inconsistencies when possible

• meta-analysis was possible only for changes in wound size

• a random-effects model was used to pooled data

• heterogeneity was quantified by I squared

• a table was provided with characteristics of ongoing and prematurely terminated randomized controlled trials

• trial methodology was routinely poor only one randomized controlled trial clearly describes concealment allocations, intention to treat analysis was explicitly described in three studies, sample size calculation was reported in only one trial

• wound closure which is the preferred FDA outcome was not consistently reported in the trials included therefore, a meta-analysis could not be performed on this outcome

• change in wound size when data was pooled favored NPWT in both the non-randomized and randomized controlled trials

• the results were presented as point estimates with 95% confidence intervals

• heterogeneity was 0%

Study weaknesses:

• quality of trials available for study

• the authors were not clear with regards to resolution of conflicts during data abstraction

• a formal analysis of publication bias was unable to be completed due to small number of studies found

• FDA states that complete wound closure is the most objective and clinical meaningful wound healing endpoint

• due to insufficient data the authors used a surrogate endpoint change in wounded size

• the authors fail to explain why a random effects model was chosen to pooled data with low heterogeneity

Comments:

The authors believe NPWT has an enormous importance in the treatment of diabetic wounds. However, valid clinical studies to evaluate effectiveness are lacking. The authors are in agreement with an earlier reviewed study ⁽¹⁾ which also concluded that the available published studies evaluating NPWT are methodologically weak.

1 Bell G., and Forbes A. A systematic review of the effectiveness of negative pressure wound therapy in the management of diabetes foot ulcers. Int Wound J 5: 233, 2008.

9/08

Comparison of Negative Pressure Wound Therapy Using Vacuum-Assisted Closure With Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers.

Blume P., Walters J., Payne W., Ayala J.,and Lantis J. Diabetes Care 31:631, 2008

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Purpose of the study:

to evaluate the safety and clinical efficacy of negative pressure wound therapy compared with advanced moist wound therapy to treat foot ulcers in diabetic patients.

The study:

multicenter randomized controlled trial enrolled 342 subjects, at foot clinics and hospitals primarily in the United States. Subjects were followed for 112 days or until ulcer closure.

Results:

a greater proportion of subjects achieved ulcer resolution using negative pressure wound therapy during the treatment phase. In assessing safety, no significant difference between the groups was observed in treatment-related complications such as infection, cellulitis,and osteomyelitis at 6 months. Negative pressure wound therapy patients experienced fewer secondary amputations.

Author's conclusion:

negative pressure wound therapy appears to be as safe as and more efficacious than advanced moist wound therapy for the treatment of diabetic foot ulcers.

_________________________________________________________________________________________________________

Strengths:

• Clear and appropriate description of randomization sequence generation and concealment allocation

• Multicenter study

• Clear clinically relevant primary outcome

• Sample size calculation described with 20% ARR (clinically relevant finding?)

• Clear inclusion and exclusion criteria described

• References given for treatment interventions

• Data analyzed as Intention to Treat and Per Protocol

• Flow diagram of subjects through study

• Disclosure of funding and financial interest by primary author

Weakness:

• Lack of blinding not of investigators nor subjects but of data collectors and analysts

• Company sponsoring the study conducted the statistical analysis rather than a neutral third party

• Failure to present data of primary outcome as point estimates with 95% CI

• Failure to discuss loss of follow-up (approximately 30% / treatment arm)

• Was trial registered?

• Were there any undisclosed conflicts of interest concerning other authors / investigators?
  
  

Comment:

The study contains several well described methodological techniques to limit bias, randomization, concealment allocation, and intention to treat analysis. However, due to the nature the study investigators and subjects were unable to be blinded. Although unblinded studies are associated with an increased treatment effect this is less likely when the primary outcome is objective such as resolution of an ulcer as opposed to soft outcomes such as patient reported outcomes (1). However, no mention was made regarding blinding of data collectors and analyzers.

The data from the study was analyzed by the company funding the study. This may be perceived as a potential source of bias, it is more reassuring to the reader when the data is analyzed by a neutral third party. The results of the primary outcome were presented as intention to treat and per protocol. It appears the author chose to assign the worst case scenario for the data lost to follow-up for both the ITT and PP analysis. Both methods were statistically significant however differed in their point estimate. Was this study clinically significant? The authors expected a 20% difference (ARR) between groups when they calculated their sample size. If the 20% difference is to be accepted as a clinically significant result then the result of the primary outcome using the intention to treat analysis was not clinically significant but only statistically significant. The per protocol analysis was both clinically and statistically significant. Furthermore, it is difficult to analyze the results with only point estimates and not 95% confidence intervals. Why 95% CI were reported for secondary measures and not the primary outcome was unclear.

There appears to be a fairly high loss to follow-up in both arms of the study (approximately 30% per treatment arm). The prognosis for subjects lost to follow-up is thought to be different than the patients who remain in the study (2). This loss of data may compromise the randomization sequence. Did the loss of follow-up affect the results of the study? The strength of the inference drawn from the study is modified by the magnitude of the difference between the intention to treat and per protocol analysis. It would have been instructive for the reader if the authors addressed this point during their discussion of the results. Interpretation the study's results would be better understood with a clear clinically important difference stated by the authors and with 95% confidence intervals reported about the point estimate of the primary outcome.

Using the data from this study 95% confidence intervals can be calculated for the Absolute Risk Reduction & Number Needed to Treat for both the intention to treat and per protocol analysis (3).

ITT

ARR 14.3 % (4.1%-24.5%)

NNT 8 (4-24)

PP

ARR 20.8% (8.5%-32.2%)

NNT 5 (3-12)

The absolute risk reduction only exceeds 20% during the per protocol analysis. The lower end of the 95% CI for both ITT and PP is greater than 0 which is consistent with a statistically significant result. Although the point estimate (ARR) for the intention to treat analysis is less than 20% , a risk reduction of more than 20% cannot be ruled out by evaluating the upper end of the 95% CI and would suggest a larger study is necessary or less loss of follow-up.

The Number Needed to Treat is a more clinician friendly metric to access efficacy in studies with dichotomous outcomes. The point estimate for NNT for both are similar 5 (PP) and 8 (ITT) however, the upper limit of the 95% CI or worse case scenario is 12 (PP) and 24 (ITT) respectively. This appears to be a large difference.

It is up to the reader to determine if the loss to follow-up, lack of blinding and lack of clinical significance reduces the inference of the results of this study. Although the use of the vacuum assisted closure appears to be more efficacious the magnitude of the effect is unclear.

The safety data were presented as treatment related rates, at six months. However, the trial evaluated treatment until day 112 or ulcer closureby any means. It would be informative to review the data on safety prior to and post intervention termination.

In addition, since the study was designed as an efficacy rather than an effectiveness study, generalizing the results to clinical practice should be done with caution.

There have been two meta-analysis published this year reviewing vacuum assisted closure and diabetic foot ulcers (4,5)

1Woods et. al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 336:601, 2008.

2 Montori V., and G. Intention-to-treat principle. CMAJ 165: 1339, 2001.

3 http://www.graphpad.com/quickcalcs/NNT1.cfm Accessed 11/3/2008.

4 Gregor S.et. al. Negative pressure wound therapy a vacuum of evidence? Arch Surg 143: 189, 2008.

5 Bell G., and Forbes A. A systematic review of the effectiveness of negative pressure wound therapy in the management of diabetes foot ulcers. Int Wound J 5: 233, 2008.

10/08

PLANTAR FASCIITIS

Effectiveness of Foot Orthoses to Treat Plantar Fasciitis

Landorf K, Keenan A, Herbert R. Archives of Internal Medicine, 166:1305-1310, 2006.

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Purpose of the study: to evaluate the short and long-term effectiveness of foot orthoses in the treatment of plantar fasciitis.
The study: one hundred thirty five patients from a university based clinic in Australia were randomized to three groups placebo, an off-the-shelf orthosis, or a custom fabricated orthosis. The patients were evaluated at baseline, three and twelve months for improvement.

Results: statistically significant improvement was only seen at three months in one category. Improvement in function was seen in the over-the-counter and custom foot orthotic devices compared to the placebo group.

Authors conclusions: foot orthotic devices produce small short-term benefits in function but have no long-term beneficial effects compared to a placebo.

_________________________________________________________________________________________________________

Study strengths:

description of a randomization process and concealment allocation process well documented
the method of obtaining a neutral negative cast and the process of fabrication of the custom device was adequately referenced
the primary outcomes were chosen prior to the study and references provided as to the validation of the outcome instrument; in addition, the outcome instrument was patient focused
the assessors fo the data were blinded to the intervention
data were analyzed using an intention to treat principle
patients were similar at baseline in all three groups with the exception of body weight and body mass index in the prefabricated group
statistical tests described to evaluate data are common to the medical literature
a sample size determination was made prior to the study and the number of patients enrolled in the study and was consistent with the sample size determination
only three patients lost to follow-up at three months and five patients lost to follow-up at 12 months
estimated effect reported as point value with 95% confidence intervals

Study weaknesses:

this was a single blinded study and the author describes how the orthotic devices were made to look alike, the reader will have to decide how effective the methods were
more than one primary outcome was chosen, this leads to confusion for the reader when different conclusions can be drawn from the results, also the more times data is analyzed, the greater the chance of making a type one error
although the instrument was validated was the entire instrument used or only a part of the Foot Health Status Questionnaire
when the sample size was determined the pain domain of the evaluation instrument was used. If one then presumes that this was the primary outcome of the study, no difference will be seen in any group at three or twelve months using the point estimates. However, at three months the upper end of the 95% confidence interval was above 15 points for the prefabricated versus the sham and the customize versus the sham. Therefore, a clinically important effect cannot be ruled out.
at 3 months 7% of the patients had protocol violations, at 12 months protocol violations increased to 23%, would this affect the measured outcome?

Comments:

This is a well designed and well-executed study whose results may be disappointing to podiatrists who advocate custom foot orthotic devices in the treatment of mechanically induced heel pain. It is sobering to note that although custom and prefabricated orthotic devices showed a statistically significant improvement in function at three months relative to a placebo there was no difference between custom and off-the-shelf foot orthotic devices at any point in the study. Whether this study is relevant to individual practices, depends upon the method of obtaining a neutral negative cast, how the positive cast is corrected, the type of device, to include materials and posting. (1)

1. Guldemond N., Leffers P., Schaper C., et al. Comparison of foot orthoses made by podiatrists, pedorthists and orthotists regarding pressure in The Netherlands. BMC Musculoskeletal Disorders, 6: 61, 2005.

Rev 6/08

Effectiveness of calf muscle stretching for the short- term treatment of plantar heel pain: a randomized trial

Radford JA, Landorf KB, Buchbindere R, and Cook C. BMC Musculoskeletal Disorders,8: 36-42; 2007.

_________________________________________________________________________________________________________

Purpose of the study: to assess the effectiveness of calf muscle stretching, for mechanically induced plantar heel pain.

The study: 92 subjects with mechanically induced plantar heel pain were randomized to receive either sham ultrasound or sham ultrasound with calf muscle stretching. The patients were followed for two weeks to assess improvement.

Results: both groups improved over the two week period however, there was no statistically significant difference between groups at the end of two weeks on any of the outcome instruments.

Authors conclusion: there was no short-term benefit to a program of calf stretching in the treatment of mechanically induced plantar heel pain.

_________________________________________________________________________________________________________

Study strengths:

clear description given of inclusion and exclusionary criteria
adequate and satisfactory description of randomization procedure
elaborate and suitable description of concealment allocation process
single blinded study, the authors provided a detailed believable process
the authors used two outcome instruments, a 100 mm visual analogue scale and the Foot Health Status Questionnaire. The Foot Health Status Questionnaire is a validated reliable instrument with references provided.
the participants in the calf muscle stretching group used a stretching wedge to standardize the technique.
a sample size calculation was performed by the authors prior to the study. Initially they described using the visual analogue scale in the calculation. Later in the description they stated that the sample size also provided adequate power to detect a minimally important difference on the pain domain of the Foot Health Status Questionnaire.
independent blinded researchers were used to enter the data and perform the statistical analysis
prior to the study it was planned that outcome data was to be analyzed by an intention to treat protocol
there were no participants lost to follow-up
the data was evaluated for significance using analysis of covariance (ANCOVA). This is not a common test however, it is appropriate in this study and well referenced.
the groups were similar at baseline.
differences between groups were presented as point estimates with 95% confidence intervals.

Study weaknesses:

multiple primary outcome instruments were used, this leads to confusion when the results are interpreted and increases the chances of a type one error.
the authors describe the method by which the sample size was calculated and cite a minimally important difference for the visual analogue scale and the pain domain of the Foot Health Status Questionnaire. It is unclear how this was determined and whether this is a clinically important difference.

Commets:

Calf muscle stretching is a common podiatric technique used for the treatment of plantar fasciitis and other foot conditions (1).

Neither the first-step pain evaluated by the visual analogue scale nor the foot pain domain of the Foot Health Status Questionnaire reached statistical significance. The upper and lower limits of the 95% confidence interval for the foot pain domain of the Foot Health Status Questionnaire was less than the minimally important difference as stated by the authors. However, the upper limit of the 95% confidence interval for first - step pain exceeded the minimally important difference as stated by the authors therefore, a minimally (clinically ?) important difference could not be ruled out.

The method of calf muscle stretching described in this study may not be the same as other techniques used in clinical practice. The authors discuss this as a limitation of the study. As a result, can this study be generalized to all methods of calf muscle stretching?

(1) Pribut SM. Current Approaches to the Management of Plantar Heel Pain Syndrome, Including the Role of Injectable Corticosteroids. JAPMA, 97: 68-74; 2007

2/08

The effectiveness of extra corporeal shock wave therapy for plantar heel pain: a systematic review and meta-analysis

Thompson C, et. al. BMC Musculoskeletal Disorders 6:19, 2005.

__________________________________________________________________________________________________________

Purpose of the Study: to investigate the effectiveness of extracorporeal shock wave therapy for the treatment of mechanically induced plantar heel pain.

The Study: a meta-analysis of randomized controlled trials was conducted to determine a precise estimate of the likely benefits of this therapy.

Results: Six RCTs (n = 897) permitted a pooled estimate of effectiveness based on pain scores

collected using 10 cm visual analogue scales for morning pain. The estimated weighted mean

difference was 0.42 (95% confidence interval 0.02 to 0.83) representing less than 0.5 cm on a visual

analogue scale. There was no evidence of heterogeneity and a fixed effects model was used..

Authors Conclusions: the effect size was very small. A sensitivity analysis including only

high quality trials did not detect a statistically significant effect.

_________________________________________________________________________________________________________

Study strengths:

• clear well-defined foreground question

• multiple databases were searched, as well as unpublished studies, search string provided

• inclusion and exclusionary criteria reported and seem reasonable for foreground question

• data was extracted by two reviewers disagreements were resolved by a discussion

• description of validity tool to evaluate RCTs seems reasonable

• thorough description of RCTs included

• clear figure representing results of search for heterogeneity and results of meta-analysis

• sensitivity analysis results reported regarding quality of studies

• cogent discussion of publication bias

Study Weaknesses:

• search strategy incomplete referred to previous study

Comments:

Carefully planned and conducted study which cast doubt upon the clinical effectiveness of ESWT in the treatment of mechanically induced heel pain at least when success of procedure judged by first step pain in the morning.

5/08

Effectiveness of Prefabricated and Customized Foot Orthoses Made From Low-Cost Foam for Noncomplicated Plantar Fasciitis: A Randomized Controlled Trial.

Purpose of the study: to compare prefabricated and customized foot orthoses made from EVA to treat noncomplicated plantar fasciitis.

Study: a double-blinded randomized controlled trial at apublic rehabilitation referral medical center. The study included one hundred forty-two adults (75% women) with plantar fasciitis. Prefabricated and customized foot orthoses, both made from EVA, were used for 8 weeks. The primary outcome was pain (modified subscale of the Foot Function Index, [FFI] pain).

Results: one hundred twenty-five participants returned to at least 1 of the follow-up evaluations (63 in the prefabricated and 62 in the customized groups). There was a significant improvement in both groups (P<.05), but there was no difference of modified FFI pain between intragroup differences at 4 (4.03 points; 95% confidence interval [CI], -4.2 to 12.3) and 8 weeks (3.93 points; 95% CI, -4.6 to 12.5).

Authors Conclusion: the low-cost prefabricated and customized foot orthoses, as used in this trial, had similar effectiveness in the treatment of noncomplicated plantar fasciitis after 8 weeks of use.

__________________________________________________________________________________________________________

Study strengths:

• the authors described the method of casting for the foot orthotic devices and provided a detailed description of the manufacturing process.

• description of concealment allocation process

• explanation of blinding process

• sample size calculation, with use of referenced / clinically important difference for outcome instrument

• participants appear to be evenly matched at baseline with respect to demographics and initial outcome score

• data was analyzed to adjust for baseline differences

• results were presented as point estimates with 95% confidence intervals, there does not appear to be a clinically important difference which was missed because of sample size
  

Study weaknesses:

• the authors excluded participants from the study if they had complicated plantar fasciitis

• a validated patient reported outcome was used however, the entire instrument was not used as the primary outcome only a subset which was was modified prior to it's use
  

• description of randomization sequence generation

• participants were asked to report cointerventions, 67% of which reported some cointervention

• authors claim to analyze the data on intention to treat basis however, it does not appear that all of the participants were analyzed at the end of the study, there was approximatly 10% loss to follow-up

Comment:

The internal validity of the study is satisfactory and the results support the authors conclusion. The reader will need to decide if the methodology of obtaining the positive impression and fabrication of the device is similar enough to generalize to their practice. In addition, the reader will need to review the participants included in the study to determine generalizability to their practice.

6/09