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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415259
• Other study ID #: 350297
• Status: Completed
• Phase: N/A
• First received: December 21, 2006
• Last updated: January 15, 2013
• Start date: May 2005
• Est. completion date: December 2008

Study information

• Verified date: January 2013
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilAustralia: Department of Human Services Radiation Safety CommiteeAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease Progression
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Laterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
• Control insole group
Flat control insoles worn inside the shoes daily for 12 months

Locations

Country	Name	City	State
Australia	Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee pain via a visual analogue scale		Measured at baseline and 12 months	No
Primary	Disease progression via MRI measurements of knee cartilage volume		Measured at baseline and 12 months	No
Secondary	Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index		Measured at baseline and 12 months	No
Secondary	Patient perceived response to treatment		Measured at baseline and 12 months.	No
Secondary	Health-related quality-of-life (via SF-36, AQoL questionnaires)		Measured at baseline and 12 months	No
Secondary	Recorded use of health care		Measured at baseline and 12 months	No