Status:
COMPLETED
Effect of Transcutaneous Electrostimulation (TENS) on Pain and Physical Function in Patients With Knee Osteoarthritis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Arco Foundation
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ag...
Detailed Description
Background Osteoarthritis (OA) is the most common arthritic condition, which is one of the leading causes of disability in adults. Currently, no treatment can stop or reverse the progressive joint de...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Men and women of at least 18 years of age
- Clinical or radiological diagnosis of knee OA according to the criteria of the American College of Rheumatology
- Knee pain lasting for six months or longer
- Radiographic evidence of at least one osteophyte at the tibiofemoral joint (Kellgren-Lawrence grade ≥ 2) or one or more of the following signs and symptoms in the knee; restricted range of motion, pain in motion, crepitations, morning stiffness
- Written informed consent
- Exclusion Criteria
- Patients diagnosed with rheumatoid arthritis or other musculoskeletal diseases affecting lower extremities
- Relevant effusion in the index knee
- Known current or remittent cancer
- Carry cardiac pacemaker or defibrillator in situ
- Knee surgery in previous 6 months
- Received treatment with arthrocentesis
- Intra-articular injection of steroids in previous 3 months
- Inability to understand instructions or to give informed consent
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01875042
Start Date
December 1 2012
End Date
January 1 2015
Last Update
April 12 2016
Active Locations (1)
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1
Institute of Social and Preventive Medicine (ISPM), University of Bern
Bern, Canton of Bern, Switzerland, 3012