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

Osteoarthritis, Knee Clinical Trial

— ETRELKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875042
• Other study ID #: 118/11
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: April 11, 2016
• Start date: December 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• TENS
Transcutaneous electrical nerve stimulation
• Sham TENS
Sham Transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
Switzerland	Institute of Social and Preventive Medicine (ISPM), University of Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Arco Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC pain subscale		End of treatment (at 3 weeks)	No
Secondary	WOMAC global subscale		Baseline, end of treatment (at 3 weeks), 3-month follow-up	No
Secondary	WOMAC physical function subscale		Baseline, end of treatment (at 3 weeks), 3-month follow-up	No
Secondary	Overall pain measured on VAS		Baseline, end of treatment (at 3 weeks), 3-month follow-up	No
Secondary	Hospital anxiety and depression scale		Baseline, end of treatment (at 3 weeks), 3-month follow-up	No
Secondary	Aberdeen measure of participation		Baseline, end of treatment (at 3 weeks), 3-month follow-up	No
Secondary	Mean analgesic intake per patient		Baseline, end of treatment (at 3 weeks), 3-month follow-up	No
Secondary	Number of drop-outs because of adverse events		End of treatment (at 3 weeks), 3-month follow-up	Yes
Secondary	Number of patients experiencing local adverse events		End of treatment (at 3 weeks), 3-month follow-up	Yes
Secondary	Number of patients experiencing any side effects		End of treatment (at 3 weeks), 3-month follow-up	Yes
Secondary	Number of patients experiencing serious side effects		End of treatment (at 3 weeks), 3-month follow-up	Yes
Secondary	Number of drop-outs		End of treatment (at 3 weeks), 3-month follow-up	No
Secondary	WOMAC pain subscale		Baseline, third treatment session, 3-month follow-up	No