Effects of Electrical Stimulation on Osteoarthritis of the Knee
Status
Completed
Conditions
Osteoarthritis, Knee
Treatments
Device: InterX 5000
Details and patient eligibility
About
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.
Enrollment
39 patients
Sex
All
Ages
50+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
39 participants in 2 patient groups, including a placebo group
1
Experimental group
Treatment:
Device: InterX 5000
2
Placebo Comparator group
Treatment:
Device: InterX 5000
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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