Sham or placebo foot orthotics for use in clinical trials

NewsBot · May 17, 2016

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Control conditions for footwear insole and orthotic research
Ryan T. Lewinson, Jay T. Worobets, Darren J. Stefanyshyn
Gait and Posture; in press

Highlights
?Commonly utilized control conditions were compared vs. participant's own shoe (OS).
?Biomechanically relevant changes relative to OS were observed for many participants.
?Magnitudes of change were similar to changes induced by intervention insoles.
?Participants? OS are recommended as control conditions in future clinical studies.
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Footwear insoles/orthotics alter variables associated with musculoskeletal injury; however, their clinical effectiveness is inconclusive. One explanation for this is the possibility that control conditions may actually produce biomechanical changes that induce clinical responses. The purpose of this study was to compare insole/orthotic control conditions to identify if variables at the ground, ankle and knee that are associated with injury, are altered relative to what participants would normally experience in their own shoes. Gait analysis was performed on 15 participants during walking and running while wearing (1) their own shoes, (2) #1 with a 3 mm flat insole, (3) a standardized shoe, and (4) #3 with a 3 mm flat insole, where external knee adduction moments, external knee adduction angular impulses, internal ankle inversion moments, and vertical ground reaction force loading rates were determined. Conditions 2?4 were expressed as percent changes relative to condition 1, and tests of proportions assessed if there was a significant number of individuals experiencing a biomechanically relevant change for each variable. Repeated-measures ANOVAs were used to identify group differences between conditions. The majority of movement-footwear-variable combinations contained a proportion of individuals experiencing biomechanically relevant changes compared to condition 1 that was significantly greater than the expected proportion of 20%. No systematic differences were found between conditions. This suggests that conditions 2-4 may alter biomechanics relative to baseline for many participants, but not in a consistent way across participants. It is recommended that participant's own footwear be used as control conditions in future trials where biomechanics are primary variables of interes
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Admin2 · May 17, 2016

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NewsBot · May 17, 2016

Also:
Selecting control interventions for use in orthotic trials: The methodological benefits of sham orthoses
Daniel R. Bonannol, Karl B. Landorf, George S. Murley, Hylton B. Menz
Contemporary Clinical Trial; May 2016 (full text)

NewsBot · May 17, 2016

Losing control over control conditions in knee osteoarthritis orthotic research
Ryan T. Lewinson, Darren J. Stefanyshyn
Contemporary Clinical Trials, Vol. 42, p258–259 April 1 2015

NewsBot · Jan 13, 2022

Construction and validation of sham insoles used in clinical trials: A systematic review
Eileen Mairi Morrow, Tim Theologis, Alpesh Kothari
Prosthet Orthot Int. 2022 Jan 10

Background: Insoles are commonly prescribed to treat pathologies in a variety of patient groups; however, there is limited evidence to guide clinical decision-making. A well-validated sham insole is critical to conducting a double-blind placebo-controlled trial.

Objectives: The aims were to establish: (1) How are sham insoles constructed? (2) What measures are undertaken to ensure adequate blinding? (3) What methods are used to validate the biomechanical effects?

Study design: A systematic search of the methodology of level I-II therapeutic evidence.

Methods: Searches were conducted in MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, and Cochrane Central Register of Controlled Trials. Inclusion criteria were placebo-controlled clinical trials, sham insoles used, treatment insoles alter biomechanics, treatment insoles meet the ISO definition of foot orthotics, sham and treatment insoles tested in normal walking, and article available in English.

Results: The search generated 270 results. Twenty-four trials were included. 19% of sham insoles were described sufficiently to be replicated. The most common sham construction characteristics were full length, ethylene-vinyl acetate material, and flat insoles. 58% of studies were double-blinded; however, many did not describe any blinding methods. There is evidence that blinding the intervention details and a similar insole appearance is effective to blind participants. 13% of studies included a shoe-only condition to allow assessment of the biomechanical effects of sham insoles.

Conclusions: There is inconsistent construction, blinding, and biomechanical validation of sham insoles. This casts a substantial doubt on the quality and reliability of the evidence base to support the prescription of insoles.
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Sham or placebo foot orthotics for use in clinical trials

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Sham or placebo foot orthotics for use in clinical trials

NewsBot The Admin that posts the news.

Admin2 Administrator Staff Member

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

NewsBot The Admin that posts the news.

Sham contractor arrangements (Australia)

Rockstar Podiatrist Needed in Amersham, Buckinghamshire

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Podiatrist Needed in Chesham & Amersham

FULLTIME PODIATRIST NEEDED Chesham/Amersham

Share This Page

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