An interventional study of TENS and Sham TENS in Osteoarthritis, Knee, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-12.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 220 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 737 studies on the registry; 178 are open to participants now.
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Exclusion Criteria
Transcutaneous Electrical Nerve Stimulation
Device: TENS
Sham Transcutaneous Electrical Nerve Stimulation
Device: Sham TENS
Transcutaneous electrical nerve stimulation
Sham Transcutaneous electrical nerve stimulation
WOMAC pain subscale
Time frame: End of treatment (at 3 weeks)
WOMAC global subscale
Time frame: 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
Overall pain measured on VAS
Time frame: 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
Aberdeen measure of participation
Time frame: 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
Number of drop-outs because of adverse events
Time frame: 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
Number of patients experiencing any side effects
Time frame: 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
Number of drop-outs
Time frame: End of treatment (at 3 weeks), 3-month follow-up
WOMAC pain subscale
Time frame: Baseline, third treatment session, 3-month follow-up
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern →