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Osteoarthritis, KneeETRELKANCT01875042

Effect of Transcutaneous Electrostimulation (TENS) on Pain and Physical Function in Patients With Knee Osteoarthritis

A study testing TENS in people with Osteoarthritis, Knee, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
TENS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteSwitzerland
Study dates
Dec 2012to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Institute of Social and Preventive Medicine (ISPM), University of Bern

    Bern, Canton of Bern, 3012

Other trials in Switzerland

About this study

Official title: Does Transcutaneous Electrical Nerve Stimulation (TENS) Affect Pain and Function in Patients With Osteoarthritis of the Knee? ETRELKA, a Randomised Controlled Trial

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.

Read the 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.

Being tested
TENS, Sham TENS
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TENSDevice

    Transcutaneous electrical nerve stimulation

  • Sham TENSDevice

    Sham Transcutaneous electrical nerve stimulation

Study groups in NCT01875042
Study groupRoleWhat they receive
TENSExperimentalTranscutaneous Electrical Nerve Stimulation
Receives: Device: TENS
Sham TENSSham comparatorSham Transcutaneous Electrical Nerve Stimulation
Receives: Device: Sham TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC pain subscale

    Measured: End of treatment (at 3 weeks)

Secondary outcomes (12)

  1. WOMAC global subscale

    Measured: Baseline, end of treatment (at 3 weeks), 3-month follow-up

  2. WOMAC physical function subscale

    Measured: Baseline, end of treatment (at 3 weeks), 3-month follow-up

  3. Overall pain measured on VAS

    Measured: Baseline, end of treatment (at 3 weeks), 3-month follow-up

  4. Hospital anxiety and depression scale

    Measured: Baseline, end of treatment (at 3 weeks), 3-month follow-up

  5. Aberdeen measure of participation

    Measured: Baseline, end of treatment (at 3 weeks), 3-month follow-up

  6. Mean analgesic intake per patient

    Measured: Baseline, end of treatment (at 3 weeks), 3-month follow-up

  7. Number of drop-outs because of adverse events

    Measured: End of treatment (at 3 weeks), 3-month follow-up

  8. Number of patients experiencing local adverse events

    Measured: End of treatment (at 3 weeks), 3-month follow-up

  9. Number of patients experiencing any side effects

    Measured: End of treatment (at 3 weeks), 3-month follow-up

  10. Number of patients experiencing serious side effects

    Measured: End of treatment (at 3 weeks), 3-month follow-up

  11. Number of drop-outs

    Measured: End of treatment (at 3 weeks), 3-month follow-up

  12. WOMAC pain subscale

    Measured: Baseline, third treatment session, 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionNov 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01875042
Sponsor's protocol ID
118/11
Acronym
ETRELKA
Status last verified
Apr 2016
First submitted
30 May 2013
Last updated
12 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34826572

Questions about this trial

What is this clinical trial studying?

A study testing TENS in people with Osteoarthritis, Knee, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC pain subscale (time frame: End of treatment (at 3 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01875042, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.

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