Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis, Treatment, Electrostimulation
Eligibility Criteria
Inclusion Criteria:
- Patient may have evidence of osteoarthritis (radiographic and/or by patient symptoms report) in more than one joint, however, osteoarthritis of one knee has been the patient's primary complaint and the focus of treatment.
- Radiographic evidence, within 6 months of enrollment, of osteoarthritis of the knee receiving treatment.
- Kellgren and Lawrence osteoarthritis classification grade 1, 2 or 3 (i.e., indicative of cartilage still remaining in joint).
- Average rating of pain associated with osteoarthritis of knee greater than or equal to 4 cm (on a 10 cm visual analog scale).
- Stiffness in knee(s) lasts less than 30 minutes (to demonstrate that stiffness is not from a more serious condition)
- Agrees to follow their randomized treatment plan and use the device.
- At least 18 years old.
- Signed informed consent.
- Erythrocyte Sedimentation rate greater than 40 mm/hour (Higher rates may be indicative of RA)
- Agrees to follow the randomized treatment plan and use of the stimulation device.
Exclusion Criteria:
- Hypersensitivity to electrical stimulation.
- Undergone within 3 months of enrollment, corticosteroid or viscosupplementation (i.e., hyaluronate) injections to the effected knee.
- If taking medications such as oral steroids, non-steroidal anti-inflammatories, or acetaminophen, patient has been on a stable dose for at least 3 months prior to enrollment. (The criteria should match the prior retrospective data studies.)
- If taking chondroprotective supplements (e.g., glucosamine and chondroitin sulfate), patient has been on a stable dose for at least 3 months prior of enrollment.
- Pathologic process at the knee (congenital defect or blunt trauma leading to structural defect such as torn anterior cruciate or meniscus ligaments).
- Problems due to mechanical/anatomical deformities (i.e., valgus greater than 5 degrees or varus greater than 1.5 degrees)
- Women who are, or plan to become pregnant during the clinical investigation.
- Known malignancy or cancer.
- Morbid obesity (BMI > 40).
- Serious or uncontrolled systemic illness (e.g., autoimmune disease, rheumatoid arthritis, diabetes mellitus or renal failure).
- Implanted devices such as a cardiac pacemaker or defibrillator
- Concurrent use of another electrical stimulation device for treatment of knee symptoms.
- Ongoing enrollment, or discontinued enrollment within the last 30 days, in another clinical trial for medical devices or biologic agents.
- Relationship other than medical (e.g., spouse or employee of investigator) with principal investigator(s) and their staff which may bias patient reports.
- Relationship with another person enrolled in the clinical investigation.
- Unable to complete the study per the investigational plan or unable to complete the case report forms.
Sites / Locations
- Osaka General Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
15 Patients (may be expanded) will receive stimulation with the following parameters: 20-minute session, to each affected knee, 3 times per week for 12 weeks. PENS for 20 minutes: Tri-phasic Lower Extremity stimulation pattern based on activation timing of the quadriceps and hamstrings for strength training (50 Hz impulses for 200 ms every 1500 ms). Minimal twitch for 5 minutes. Moderate to strong, but well-tolerated twitch contractions for 15 minutes. Electrodes placed on quadriceps and hamstrings.
5 Patients (may be expanded) will receive stimulation with the following parameters: 20-minute session, to each affected knee, 3 times per week for 12 weeks. Placebo PENS for 20 minutes: Electrodes placed on quadriceps and hamstrings.