Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and exercise on knee Osteoarthritis (OA): a randomised controlled trial

Completed

Conditions: Knee osteoarthritis
Musculoskeletal Diseases
Arthropathies

Registration Number: ISRCTN12912789

Lead Sponsor: niversity of the West of England (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 261

Inclusion Criteria

Patients referred to United Bristol Healthcare NHS Trust (UBHT) for physiotherapy with a diagnosis of knee OA will be invited to participate. The clinical and radiographic criteria of the American College of Rheumatology (ACR) will be applied, whereby a diagnosis of knee OA will require each patient:
1. To complain of knee pain
2. To have radiographic (X-ray) evidence of osteophytes
3. To meet at least one of the following three criteria:
3.1. 50 years or older
3.2. Morning stiffness that lasts for less than 30 minutes
3.3. Crepitus on active movement

Where available, X-rays taken within the last 12 months will be used. Otherwise, new X-rays will be ordered. Following appropriate training and assessment of competence, the principal investigator will screen all X-rays for evidence of osteophytes. All X-rays will later be reported on in detail by Professor John Kirwan (Rheumatology Consultant, UBHT) and graded for severity as described in previous work carried out at UBHT.

Exclusion Criteria

1. Co-morbidities that would prevent participation in the exercise programme (such as severe respiratory or cardiac disease)
2. Unable to mobilise independently either unaided or with the use of one stick
3. Unable to participate fully in group activities for other reasons such as dementia
4. Contraindications to TENS
5. Previous experience of using TENS

Where there is any doubt, a medical practitioner from the Rheumatology Department at UBHT will be available for advice on the inclusion of patients with co-morbidities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale (at baseline, 3, 6, 12 and 24 weeks).

Secondary Outcome Measures

Name	Time	Method
1. Total Western Ontario and McMaster Universities Osteoarthritis Index score and pain and stiffness subscale scores (at baseline, 3, 6, 12 and 24 weeks)<br>2. Knee extensor torque (quadriceps strength) (at baseline, 3, 6, 12 and 24 weeks)<br>3. Patient global assessment of change (at 3, 6, 12 and 24 weeks)<br>4. Self efficacy for exercise (at baseline and 24 weeks)<br>5. Self-reported exercise adherence (at baseline, 3, 6, 12 and 24 weeks)<br>6. Logged TENS usage time (at 6 weeks)