NCT01875042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

May 30, 2013

Last Update Submit

April 11, 2016

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • WOMAC pain subscale

    End of treatment (at 3 weeks)

Secondary Outcomes (12)

  • WOMAC global subscale

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

  • WOMAC physical function subscale

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

  • Overall pain measured on VAS

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

  • Hospital anxiety and depression scale

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

  • Aberdeen measure of participation

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

  • +7 more secondary outcomes

Study Arms (2)

TENS

EXPERIMENTAL

Transcutaneous Electrical Nerve Stimulation

Device: TENS

Sham TENS

SHAM COMPARATOR

Sham Transcutaneous Electrical Nerve Stimulation

Device: Sham TENS

Interventions

TENSDEVICE

Transcutaneous electrical nerve stimulation

TENS
Sham TENSDEVICE

Sham Transcutaneous electrical nerve stimulation

Sham TENS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bern, Canton of Bern, 3012, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 34826572DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Stephan Reichenbach, MD

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

    PRINCIPAL INVESTIGATOR

  • Peter Jüni, Prof.

    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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 11, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations

CH(1)