Effect of Transcutaneous Electrostimulation (TENS) on Pain and Physical Function in Patients With Knee Osteoarthritis
NCT01875042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2016-04-12
Summary
The proposed study is a multi-center, randomized, double blind (patient and assessor), sham controlled clinical trial using a parallel 2 group design recruiting 220 patients of at least 18 years of age. The investigators will include patients presenting with clinically and radiologically diagnosed knee OA according to the criteria of the American College of Rheumatology, who experienced knee pain lasting for at least six months, and were diagnosed with radiographic severity of ≥ 2 on the Kellgren-Lawrence grading system or had one or more of the following signs and symptoms in the knee; restricted range of motion, pain in motion, crepitations, morning stiffness. Patients will be randomly allocated to receive TENS or sham TENS for 3 weeks.
Conditions
- Osteoarthritis, Knee
Interventions
- DEVICE
-
TENS
Transcutaneous electrical nerve stimulation
- DEVICE
-
Sham TENS
Sham Transcutaneous electrical nerve stimulation
Sponsors & Collaborators
-
Arco Foundation
collaborator UNKNOWN -
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
Stephan Reichenbach, MD · Institute of Social and Preventive Medicine (ISPM), University of Bern
-
Peter Jüni, Prof. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Canada
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2014-11-30
- Completion
- 2015-01-31
Countries
- Switzerland
Study Locations
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