The efficacy of foot orthoses in individuals with patellofemoral osteoarthritis: a randomised feasibility trial.
Foot orthoses
Osteoarthritis
Patellofemoral
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
2019
2019
Historique:
received:
15
11
2018
accepted:
21
06
2019
entrez:
25
7
2019
pubmed:
25
7
2019
medline:
25
7
2019
Statut:
epublish
Résumé
Foot orthoses have the potential to be an efficacious treatment for patellofemoral osteoarthritis (PFOA) but have not been evaluated in clinical trials in this population. This study aimed to determine the: (i) feasibility of conducting a randomised controlled trial (RCT) investigating the efficacy of foot orthoses in individuals with PFOA; and (ii) effects of foot orthoses versus flat shoe inserts on pain, function, and knee-related quality of life (QOL). This 6-week, single-blinded pilot RCT randomly allocated participants with PFOA to receive foot orthoses or flat inserts. The primary outcome of feasibility was determined via the following parameters: one participant recruited per week, 20% (35 h/week) adherence to the intervention, 50% log book completion rate, and < 20% drop-out, with results reported using descriptive statistics. Secondary outcomes included average and maximum pain severity (100 mm visual analogue scale), Anterior Knee Pain Scale, and Knee injury and Osteoarthritis Outcome Score, analysed using analysis of covariance. Twenty-six participants (16 women; mean (SD) age of 60 (8) years) with PFOA were recruited. All feasibility parameters were exceeded, with three participants recruited per week, > 20% (37.2 [9.8] hours/week) adherence to the intervention, 69.2% (18/26) log-book completion, and 3.8% (1/26) drop-outs. The most common adverse events were arch irritation and shoe fit issues, which were more common in the foot orthoses group (67.9% This study supports the feasibility of a full-scale RCT to determine the efficacy of foot orthoses The trial protocol was retrospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR number: 12616001287426).
Sections du résumé
BACKGROUND
BACKGROUND
Foot orthoses have the potential to be an efficacious treatment for patellofemoral osteoarthritis (PFOA) but have not been evaluated in clinical trials in this population. This study aimed to determine the: (i) feasibility of conducting a randomised controlled trial (RCT) investigating the efficacy of foot orthoses in individuals with PFOA; and (ii) effects of foot orthoses versus flat shoe inserts on pain, function, and knee-related quality of life (QOL).
METHODS
METHODS
This 6-week, single-blinded pilot RCT randomly allocated participants with PFOA to receive foot orthoses or flat inserts. The primary outcome of feasibility was determined via the following parameters: one participant recruited per week, 20% (35 h/week) adherence to the intervention, 50% log book completion rate, and < 20% drop-out, with results reported using descriptive statistics. Secondary outcomes included average and maximum pain severity (100 mm visual analogue scale), Anterior Knee Pain Scale, and Knee injury and Osteoarthritis Outcome Score, analysed using analysis of covariance.
RESULTS
RESULTS
Twenty-six participants (16 women; mean (SD) age of 60 (8) years) with PFOA were recruited. All feasibility parameters were exceeded, with three participants recruited per week, > 20% (37.2 [9.8] hours/week) adherence to the intervention, 69.2% (18/26) log-book completion, and 3.8% (1/26) drop-outs. The most common adverse events were arch irritation and shoe fit issues, which were more common in the foot orthoses group (67.9%
CONCLUSION
CONCLUSIONS
This study supports the feasibility of a full-scale RCT to determine the efficacy of foot orthoses
TRIAL REGISTRATION
BACKGROUND
The trial protocol was retrospectively registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR number: 12616001287426).
Identifiants
pubmed: 31338205
doi: 10.1186/s40814-019-0469-7
pii: 469
pmc: PMC6625074
doi:
Types de publication
Journal Article
Langues
eng
Pagination
90Déclaration de conflit d'intérêts
Competing interestsThe authors declare that they have no competing interests.
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