Status:
COMPLETED
Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study
Lead Sponsor:
RS Medical
Collaborating Sponsors:
Accelerated Care Plus
Research Institute of Health and Science (RIHSE)
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to investigate the benefits of the Patterned Neuromuscular Electrical Stimulation (PENS) for the treatment of osteoarthritis. The rationale for this investigation is to ass...
Detailed Description
There will be two study conditions; patients will be assigned to PENS treatment or to the control group. Study arm 1 - 15 Patients (may be expanded) will receive stimulation with the following parame...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00701506
Start Date
May 1 2008
End Date
November 1 2010
Last Update
December 9 2011
Active Locations (1)
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1
Osaka General Medical Center
Osaka, Japan