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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Laterally wedged shoe insoles
Control insole group
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Laterally wedged shoe insoles

Flat control insoles

Arm Description

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

Outcomes

Primary Outcome Measures

Knee pain via a visual analogue scale
Disease progression via MRI measurements of knee cartilage volume

Secondary Outcome Measures

Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
Patient perceived response to treatment
Health-related quality-of-life (via SF-36, AQoL questionnaires)
Recorded use of health care

Full Information

First Posted
December 21, 2006
Last Updated
January 15, 2013
Sponsor
University of Melbourne
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00415259
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laterally wedged shoe insoles
Arm Type
Experimental
Arm Description
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Arm Title
Flat control insoles
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Laterally wedged shoe insoles
Intervention Description
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Intervention Type
Device
Intervention Name(s)
Control insole group
Intervention Description
Flat control insoles worn inside the shoes daily for 12 months
Primary Outcome Measure Information:
Title
Knee pain via a visual analogue scale
Time Frame
Measured at baseline and 12 months
Title
Disease progression via MRI measurements of knee cartilage volume
Time Frame
Measured at baseline and 12 months
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
Time Frame
Measured at baseline and 12 months
Title
Patient perceived response to treatment
Time Frame
Measured at baseline and 12 months.
Title
Health-related quality-of-life (via SF-36, AQoL questionnaires)
Time Frame
Measured at baseline and 12 months
Title
Recorded use of health care
Time Frame
Measured at baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Bennell, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21593096
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.
Results Reference
derived
PubMed Identifier
17892539
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.
Results Reference
derived

Learn more about this trial

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

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