Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
RS Medical Accelerated Care Plus Research Institute of Health and Science (RIHSE) |
---|---|
Information provided by: | RS Medical |
ClinicalTrials.gov Identifier: | NCT00701506 |
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 assess the benefit of PENS in the alleviation of symptoms of osteoarthritis and elucidating the mechanism of action of PENS.
Condition | Intervention | Phase |
---|---|---|
Knee Osteoarthritis |
Device: Patterned Electrical Neuromuscular Stimulation Device: Placebo PENS |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Patterned Electrical Neuromuscular Stimulation and Therapeutic Exercise for Osteoarthritis of the Knee: Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
15 Patients (may be expanded) will receive stimulation with the following parameters:
|
Device: Patterned Electrical Neuromuscular Stimulation
|
2: Placebo Comparator
5 Patients (may be expanded) will receive stimulation with the following parameters:
|
Device: Placebo PENS
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Natalia Homestead, M.S. CCRA | 800-929-6581 | nhomeste@rsmedical.com |
Japan | |
Osaka General Medical Center | Recruiting |
Osaka, Japan | |
Contact: Akio Kobayashi, MD | |
Principal Investigator: Akio Kobayashi, MD |
Study Director: | William Carroll | RS Medical |
Responsible Party: | RS Medical ( William Carroll / Vice President of Reasearch and Product Development ) |
Study ID Numbers: | RSMED-OA-02 |
Study First Received: | June 17, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00701506 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Knee Osteoarthritis Treatment Electrostimulation |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |