| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN56847801 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0355127318 |
| Public title | A comparative study of static magnetic field (SMF) therapy against Transcutaneous Electrical Nerve Stimulation (TENS) therapy on mechanical back pain and neck pain. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Back pain |
| Study hypothesis | The project aims to identify
1. The efficacy of magnet therapy for treating chronic mechanical back and neck pain
2. The efficacy of magnet therapy against traditional TENS therapy for treating chronic mechanical back and neck pain
Hypothesis: Using magnetic therapy will decrease pain and improve quality of life, sleep, reduce analgesic intake more than traditional TENS therapy on mechanical back and neck pain. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Chronic pain consultants referrals only
2. Patients normally eligible for TENS therapy
3. Ability to understand simple instructions
4. Ability to apply therapies by self/significant other
5. Patients with a diagnosis of mechanical back or neck pain only (no neurological deficits) |
| Participants - exclusion criteria | 1. Patients who have a pacemaker
2. Have intracranial clips/aneurysms
3. Would not be able to apply therapies by self or have no help for applying
5. Are outside the age range
6. Are pregnant or may be trying to get pregnant
Reasons include: magnets can increase the failure of pacemakers, having metal work within the head area. Pregnancy: magnets may be harmful to the unborn child (although it hasn¿t been clinically proven). |
| Patient information material |
|
| Anticipated start date | 01/08/2003 |
| Anticipated end date | 30/04/2004 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients referred via the 3 chronic pain consultants will be entered into the study if fitting the inclusion criteria. Twenty-five for TENS and 25 for magnet therapy. A trial of two therapies: conventional TENS using a programmable machine and a specific programme for 2 hours 3 times a day or a magnetic belt which will work continuously between rising and bedtime. They will be randomly selected for a trial of a TENS machine or magnetic belt for a period of 6 weeks. There will be a week¿s window before the cross-over therapy for a further 6 weeks. At each completion of the therapy a short evaluation questionnaire will be completed. Normal analgesics can be continued throughout the trial but they are advised that if they receive benefit from the therapy they can reduce their analgesic intake. |
| Primary outcome measure(s) | We have developed a short questionnaire to be completed at the end of each therapy to identify if there has been any change in the pain or their behaviour. We are looking for differences in:
1. Level of pain
2. Functional activity
3. Medication reduction
4. Sleep activity
5. Quality of Life
Each section can score a maximum of 20, the lowest number of 0 being the best outcome. The total of all sections are calculated to a maximum of 100. The higher the score the worse the outcome. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Mid Essex Hospital Services NHS Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Ms Karen MacKrodt |
| Contact details | Mid Essex Hospital Services NHS Trust
Broomfield Hospital
Chelmsford
United Kingdom
CM1 7ET |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN56847801 |
| Date last extracted from ISRCTN register | 17/04/2008 |
