Clinical trial NCT00415259: Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
Official title: Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2006-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.


Eligibility criteria: Inclusion Criteria:

* Eligibility will be confirmed by radiographic and clinical examination
* People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking \>3 on an 11-point scale
* varus knee malalignment on standing anteroposterior lower limb x-ray.

Exclusion Criteria:

* advanced radiographic knee OA (Kellgren and Lawrence stage 4
* knee surgery or intra-articular corticosteroid injection within 6 months
* current or past (within 4 weeks) oral corticosteroid use
* systemic arthritic conditions
* history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
* any other muscular, joint or neurological condition affecting lower limb function
* ankle/foot pathology or pain that precludes the use of insoles
* use of foot orthotics within past 6 months and
* use of footwear that does not accomodate an insole.

Primary outcomes:
measure: Knee pain via a visual analogue scale
timeFrame: Measured at baseline and 12 months
measure: Disease progression via MRI measurements of knee cartilage volume
timeFrame: Measured at baseline and 12 months
Secondary outcomes:
measure: Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
timeFrame: Measured at baseline and 12 months
measure: Patient perceived response to treatment
timeFrame: Measured at baseline and 12 months.
measure: Health-related quality-of-life (via SF-36, AQoL questionnaires)
timeFrame: Measured at baseline and 12 months
measure: Recorded use of health care
timeFrame: Measured at baseline and 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Kim Bennell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennell KL, Bowles KA, Payne C, Cicuttini F, Williamson E, Forbes A, Hanna F, Davies-Tuck M, Harris A, Hinman RS. Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial. BMJ. 2011 May 18;342:d2912. doi: 10.1136/bmj.d2912.
citation: Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musculoskelet Disord. 2007 Sep 24;8:96. doi: 10.1186/1471-2474-8-96.