NCT00601497
Completed
Not Applicable
Effects of Electrical Stimulation on Osteoarthritis of the Knee
ConditionsOsteoarthritis, Knee
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- University of Virginia
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Knee Pain
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of this study is to find out whether electrical stimulation can reduce knee pain and increase function in people with osteoarthritis of the knee.
Investigators
Eligibility Criteria
Inclusion Criteria
- •50 years of age or older
- •Diagnosis of primary osteoarthritis of the knee (as defined by American College of Rheumatology criteria)
- •Knee pain of at least six months duration
- •Moderate or greater knee pain (defined as a score of 3 or greater on an 11 point numeric pain rating scale) for most days in the last month
- •Willing to abide by protocol and treatment schedule.
Exclusion Criteria
- •Implants, such as pacemaker, TENS, or insulin pump, incompatible with electrical stimulation
- •Uncontrolled concomitant disease affecting the knee, such as: rheumatoid arthritis, systemic lupus erythema, psoriatic arthritis
- •Pregnant or breast-feeding
- •Intra-articular corticosteroid or hyaluronic acid injection into the knee within 3 months preceding study
- •Arthroscopy of the knee within the past year
- •Significant injury to the knee within the past 6 months
- •Use of assistive devices other than a cane or knee brace
- •Disease of spine or other lower extremity joints of sufficient degree to affect assessment of the knee
Outcomes
Primary Outcomes
Knee Pain
Time Frame: Baseline, Week 4, Week 8, and Week 12
Secondary Outcomes
- Knee function(Baseline, Week 4, Week 8, and Week 12)
- Knee stiffness(Baseline, Week 4, Week 8, and Week 12)
- Patient global assessment(Baseline, Week 4, Week 8, and Week 12)
- Health-related quality of life(Baseline, Week 4, Week 8, and Week 12)
Study Sites (1)
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