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

NCT00415259 | Completed DMC

• 1 other identifier: 350297
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Laterally wedged shoe insoles

EXPERIMENTAL

Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Device: Laterally wedged shoe insoles

Flat control insoles

OTHER

Device: Control insole group

Interventions

Laterally wedged shoe insoles DEVICE

Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Laterally wedged shoe insoles

Control insole group DEVICE

Flat control insoles worn inside the shoes daily for 12 months

Flat control insoles

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Melbourne: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Related Publications (2)

• 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.

  PMID: 21593096 DERIVED

• 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.

  PMID: 17892539 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kim Bennell, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Kim Bennell

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: May 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

AU (1)