Osteoarthritis, Knee
Conditions
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.
Interventions
DEVICEInterX 5000
20-30 minute device sessions on the following schedule: 3 times per week for 3 weeks, then 2 times per week for 3 weeks, then 1 time per week for 2 weeks.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Pain | Baseline, Week 4, Week 8, and Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed