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Clinical Trials/NCT01763515
NCT01763515
Unknown
Phase 2

The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis

Isfahan University of Medical Sciences1 site in 1 country120 target enrollmentOctober 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Isfahan University of Medical Sciences
Enrollment
120
Locations
1
Primary Endpoint
Change from baseline in knee pain severity after 2 months.
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
October 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Farnaz Dehgan Hosseinabadi

Dr.

Isfahan University of Medical Sciences

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.

Outcomes

Primary Outcomes

Change from baseline in knee pain severity after 2 months.

Time Frame: Up to 2 months

The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.

Secondary Outcomes

  • Change from baseline in knee's functional degree after 2 months.(Up to 2 months.)

Study Sites (1)

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