Condition category
Musculoskeletal Diseases
Date applied
25/07/2007
Date assigned
03/10/2007
Last edited
24/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shea Palmer

ORCID ID

Contact details

Faculty of Health and Social Care
University of the West of England
Blackberry Hill
Bristol
BS16 1DD
United Kingdom
+44 (0)117 328 8919
Shea.Palmer@uwe.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PRF/06/1

Study information

Scientific title

Acronym

Study hypothesis

Null Hypothesis:
There is no statistically significant difference in assessed outcomes between the effects of TENS and OA knee group, sham TENS and OA knee group or OA knee group alone in people with knee OA.

Ethics approval

Ethics approval received from the Cambridgeshire 2 Research Ethics Committee on the 5th September 2007 (ref: 07/H0308/209). Site-specific approval added 11th September 2007.

Study design

A randomised sham-controlled trial with three parallel arms.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Knee osteoarthritis

Intervention

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 TENS will receive a 30-minute appointment to be trained in the use of their TENS machine. They will receive a TENS device for their personal use from the date of TENS instruction and throughout the 6 week duration of the OA knee group. Information will detail the existence of different TENS devices, that some do not produce perceptible sensations, and that participants may receive an active or inactive device (in line with principles of fully informed consent). Those patients receiving active TENS will be instructed to select parameters that generate a 'strong but comfortable' tingling sensation within or close to the site of pain. Those receiving sham TENS will be instructed to select parameters that are within the middle range of those available. Dummy devices (the displays are active but there is no current output) will be used to administer sham TENS. All patients will be instructed to use the device as much as needed. Telephone support will be provided by the TENS instructor as requested by participants and this will be logged.

OA knee group:
Two senior therapists will be trained to deliver the OA knee groups. To maximise consistency, the same therapist will aim to lead all six sessions of each group and a standardised instruction protocol supporting PowerPoint slides will be used for the education component. All participants will take part in the OA knee group. This will involve a group of up to 12 patients attending for 1 hour (30 minutes of education and 30 minutes of group exercise) on six consecutive weeks. The education programme aims to enhance patients' ability to self-manage their knee OA. It includes setting personal objectives, advice on pacing, managing flare-ups, information about diet, medical management of OA and local community exercise opportunities, alongside advice about long-term adherence to exercise. The exercise component includes 5 minute warm up, followed by a circuit of twelve exercises aimed at improving lower limb strength, proprioception and function. Each exercise has specific ideas for progression which patients advance onto as able over the 6-week programme. During the first session each exercise is performed for 1 minute, with 1 minute between exercises to move to the next station. On the subsequent five sessions each exercise is performed for 2 minutes with 1 minute in between. All patients are taught home exercises during the second session and advised to perform them daily.

Performance of home exercises is checked on week 3 and as requested by the patients thereafter.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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)

Overall trial start date

01/10/2007

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

261 (87 in each arm)

Participant 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.

Recruitment start date

01/10/2007

Recruitment end date

30/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Health and Social Care
Bristol
BS16 1DD
United Kingdom

Sponsor information

Organisation

University of the West of England (UK)

Sponsor details

Coldharbour Lane
Bristol
BS16 1QY
United Kingdom
+44 (0)117 965 6261
Robin.Means@uwe.ac.uk

Sponsor type

University/education

Website

http://www.uwe.ac.uk

Funders

Funder type

Research organisation

Funder name

Physiotherapy Research Foundation (UK) (ref: PRF/06/1)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23983090

Publication citations

  1. Results

    Palmer S, Domaille M, Cramp F, Walsh N, Pollock J, Kirwan J, Johnson MI, Transcutaneous electrical nerve stimulation as an adjunct to education and exercise for knee osteoarthritis: a randomized controlled trial., Arthritis Care Res (Hoboken), 2014, 66, 3, 387-394, doi: 10.1002/acr.22147.

Additional files

Editorial Notes