Clinical trial NCT01875042: Effect of Transcutaneous Electrostimulation (TENS) on Pain and Physical Function in Patients With Knee Osteoarthritis
Official title: Does Transcutaneous Electrical Nerve Stimulation (TENS) Affect Pain and Function in Patients With Osteoarthritis of the Knee? ETRELKA, a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Arco Foundation
First posted: 2013-06-11
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: WOMAC pain subscale
timeFrame: End of treatment (at 3 weeks)
Secondary outcomes:
measure: WOMAC global subscale
timeFrame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
measure: WOMAC physical function subscale
timeFrame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
measure: Overall pain measured on VAS
timeFrame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
measure: Hospital anxiety and depression scale
timeFrame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
measure: Aberdeen measure of participation
timeFrame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
measure: Mean analgesic intake per patient
timeFrame: Baseline, end of treatment (at 3 weeks), 3-month follow-up
measure: Number of drop-outs because of adverse events
timeFrame: End of treatment (at 3 weeks), 3-month follow-up
measure: Number of patients experiencing local adverse events
timeFrame: End of treatment (at 3 weeks), 3-month follow-up
measure: Number of patients experiencing any side effects
timeFrame: End of treatment (at 3 weeks), 3-month follow-up
measure: Number of patients experiencing serious side effects
timeFrame: End of treatment (at 3 weeks), 3-month follow-up
measure: Number of drop-outs
timeFrame: End of treatment (at 3 weeks), 3-month follow-up
measure: WOMAC pain subscale
timeFrame: Baseline, third treatment session, 3-month follow-up
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Institute of Social and Preventive Medicine (ISPM), University of Bern
Study officials:
affiliation: Institute of Social and Preventive Medicine (ISPM), University of Bern
name: Stephan Reichenbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Peter Jüni, Prof.
role: STUDY_DIRECTOR
References:
citation: Reichenbach S, Juni P, Hincapie CA, Schneider C, Meli DN, Schurch R, Streit S, Lucas C, Mebes C, Rutjes AWS, da Costa BR. Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial. Osteoarthritis Cartilage. 2022 Mar;30(3):426-435. doi: 10.1016/j.joca.2021.10.015. Epub 2021 Nov 23.