- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875042
Effect of Transcutaneous Electrostimulation (TENS) on Pain and Physical Function in Patients With Knee Osteoarthritis (ETRELKA)
Does Transcutaneous Electrical Nerve Stimulation (TENS) Affect Pain and Function in Patients With Osteoarthritis of the Knee? ETRELKA, a Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 degeneration caused by OA. Most clinical interventions aim to improve pain and physical function. Transcutaneous electrical nerve stimulation (TENS) is widely used in the management of knee OA to relieve osteoarthritic pain and facilitate the performance of therapeutic activities in order to maintain or improve physical function. Although its use is widespread, the available evidence is of questionable quality. An adequately sized and well conducted randomized controlled trial (RCT) investigating the effectiveness and safety of TENS as treatment modality for knee OA is warranted to assist clinicians and policy makers to make decisions that are based on high-quality evidence, ultimately optimizing delivery of health-care in knee OA.
Objective
To determine TENS safety and effectiveness on pain and physical function compared to sham TENS in patients with knee OA.
Methods
Multi-center, randomized, double blind (patient and assessor), sham controlled clinical trial using a parallel 2 group design. Patients will be randomly allocated to receive TENS or sham TENS for 3 weeks. Informed consent of eligible patients will be obtained prior to randomization. Patients will be assigned on a 1:1 basis to the TENS or sham TENS group. Randomization will be centralized using randomization software and an electronic randomization form, generated by the trial coordinating centre (CTU Bern). Patients will be randomized once demographic data and selection criteria are completed by the recruiting physician in an electronic form. Randomization will be stratified according to treatment centre, TENS naivety and clinical severity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bern, Switzerland, 3012
- Institute of Social and Preventive Medicine (ISPM), University of Bern
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TENS
Transcutaneous Electrical Nerve Stimulation
|
Transcutaneous electrical nerve stimulation
|
SHAM_COMPARATOR: Sham TENS
Sham Transcutaneous Electrical Nerve Stimulation
|
Sham Transcutaneous electrical nerve stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
WOMAC pain subscale
Time Frame: End of treatment (at 3 weeks)
|
End of treatment (at 3 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
WOMAC global subscale
Time Frame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
WOMAC physical function subscale
Time Frame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Overall pain measured on VAS
Time Frame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Hospital anxiety and depression scale
Time Frame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Aberdeen measure of participation
Time Frame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Mean analgesic intake per patient
Time Frame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Baseline, end of treatment (at 3 weeks), 3-month follow-up
|
Number of drop-outs because of adverse events
Time Frame: End of treatment (at 3 weeks), 3-month follow-up
|
End of treatment (at 3 weeks), 3-month follow-up
|
Number of patients experiencing local adverse events
Time Frame: End of treatment (at 3 weeks), 3-month follow-up
|
End of treatment (at 3 weeks), 3-month follow-up
|
Number of patients experiencing any side effects
Time Frame: End of treatment (at 3 weeks), 3-month follow-up
|
End of treatment (at 3 weeks), 3-month follow-up
|
Number of patients experiencing serious side effects
Time Frame: End of treatment (at 3 weeks), 3-month follow-up
|
End of treatment (at 3 weeks), 3-month follow-up
|
Number of drop-outs
Time Frame: End of treatment (at 3 weeks), 3-month follow-up
|
End of treatment (at 3 weeks), 3-month follow-up
|
WOMAC pain subscale
Time Frame: Baseline, third treatment session, 3-month follow-up
|
Baseline, third treatment session, 3-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephan Reichenbach, MD, Institute of Social and Preventive Medicine (ISPM), University of Bern
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 118/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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