Back to resultsLaterally Wedged Insoles for Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Laterally wedged insoles
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Joint Diseases, Arthritis, Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Symptomatic medial femorotibial knee OA,
- Daily knee pain for at least 1 month in the last 3 months,
- Radiographic evidence of medial femorotibial knee OA,
- Normal erythrocyte sedimentation rate.
Exclusion Criteria:
- Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography,
- Knee joint lavage in past 3 months,
- Intra-articular corticosteroid injection during the past 3 months,
- Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.
Sites / Locations
- Department of Rehabilitation, Alzahra Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laterally wedged insoles
Arm Description
Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.
Outcomes
Primary Outcome Measures
Change from baseline in knee pain severity after 2 months.
The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.
Secondary Outcome Measures
Change from baseline in knee's functional degree after 2 months.
Knee's functional degree (Edinburg Index) is evaluated at baseline and then 2 months after therapy.
Full Information
NCT ID
NCT01763515
First Posted
December 28, 2012
Last Updated
January 8, 2013
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01763515
Brief Title
Laterally Wedged Insoles for Patients With Knee Osteoarthritis
Official Title
The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. This study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.
Detailed Description
Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. Because of the high incidence of knee osteoarthritis in the elderly and the seriousness of drug effects in this age group and lack of controlled study in our country regarding the possible benefits or lack of benefit of laterally wedged insoles in patients with knee osteoarthritis and also due to strike, and results of mixed in other studies, this study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Joint Diseases, Arthritis, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laterally wedged insoles
Arm Type
Experimental
Arm Description
Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.
Intervention Type
Procedure
Intervention Name(s)
Laterally wedged insoles
Intervention Description
Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.
Primary Outcome Measure Information:
Title
Change from baseline in knee pain severity after 2 months.
Description
The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Change from baseline in knee's functional degree after 2 months.
Description
Knee's functional degree (Edinburg Index) is evaluated at baseline and then 2 months after therapy.
Time Frame
Up to 2 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic medial femorotibial knee OA,
Daily knee pain for at least 1 month in the last 3 months,
Radiographic evidence of medial femorotibial knee OA,
Normal erythrocyte sedimentation rate.
Exclusion Criteria:
Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography,
Knee joint lavage in past 3 months,
Intra-articular corticosteroid injection during the past 3 months,
Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farnaz Dehghan, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Alzahra Hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
19939281
Citation
Hinman RS, Bowles KA, Bennell KL. Laterally wedged insoles in knee osteoarthritis: do biomechanical effects decline after one month of wear? BMC Musculoskelet Disord. 2009 Nov 25;10:146. doi: 10.1186/1471-2474-10-146.
Results Reference
background
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
background
PubMed Identifier
14697682
Citation
Pham T, Maillefert JF, Hudry C, Kieffert P, Bourgeois P, Lechevalier D, Dougados M. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis. A two-year prospective randomized controlled study. Osteoarthritis Cartilage. 2004 Jan;12(1):46-55. doi: 10.1016/j.joca.2003.08.011.
Results Reference
background
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Laterally Wedged Insoles for Patients With Knee Osteoarthritis
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