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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12912789
Enrollment
261
Registered
2007-10-03
Start date
2007-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis Musculoskeletal Diseases Arthropathies

Interventions

Participants will receive either: 1. TENS and OA knee group 2. Sham TENS and OA knee group 3. OA knee group alone TENS intervention: Those participants allocated to receive either active or sham TE

Sponsors

University of the West of England (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Secondary

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

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026