|
Welcome
|
|
12 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
|
| [ ...Back to search results ] | [ Print-friendly version ] |
| Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and exercise on knee Osteoarthritis (OA): a randomised controlled trial |
| Source of record | UK Trials |
| ISRCTN | ISRCTN12912789 |
| Date ISRCTN assigned | 03/10/2007 |
| Local reference number(s) | PRF/06/1 |
| Public title | Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and exercise on knee Osteoarthritis (OA): a randomised controlled trial |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Knee osteoarthritis |
| 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. |
| Design/methodology | A randomised, sham-controlled trial with three parallel arms. |
| Research ethics review | 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. |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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. |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Ongoing |
| Target number of participants | 261 (87 in each arm) |
| 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 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. |
| Primary outcome measure(s) | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale (at baseline, 3, 6, 12 and 24 weeks). |
| Secondary outcome measure(s) | 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) |
| Sources of funding | Physiotherapy Research Foundation (UK) (ref: PRF/06/1) |
| Sponsor name | University of the West of England (UK) |
| Sponsor details | Coldharbour Lane Bristol United Kingdom BS16 1QY |
| Sponsor telephone | +44 (0)117 965 6261 |
| Sponsor email | Robin.Means@uwe.ac.uk |
| Sponsor website | http://www.uwe.ac.uk |
| Contact name | Dr Shea Palmer |
| Contact details | Faculty of Health and Social Care University of the West of England Blackberry Hill Bristol United Kingdom BS16 1DD |
| Contact telephone | +44 (0)117 328 8919 |
| Contact email | Shea.Palmer@uwe.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN12912789 |
| Date last extracted from ISRCTN register | 17/04/2008 |
|
|
|
|
|
| © 2012 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | |
|
|
|
|