Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Laterally wedged shoe insoles; Device: Control insole group

• Registration Number: NCT00415259
• Lead Sponsor: University of Melbourne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laterally wedged shoe insoles	Laterally wedged shoe insoles	Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Flat control insoles	Control insole group	-

Primary Outcome Measures

Name	Time	Method
Knee pain via a visual analogue scale	Measured at baseline and 12 months
Disease progression via MRI measurements of knee cartilage volume	Measured at baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index	Measured at baseline and 12 months
Patient perceived response to treatment	Measured at baseline and 12 months.
Health-related quality-of-life (via SF-36, AQoL questionnaires)	Measured at baseline and 12 months
Recorded use of health care	Measured at baseline and 12 months

Trial Locations

Locations (1)

Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne; 🇦🇺 Melbourne, Victoria, Australia