A comparative study of static magnetic field (SMF) therapy against transcutaneous electrical nerve stimulation (TENS) therapy on mechanical back pain and neck pain
| ISRCTN | ISRCTN56847801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56847801 |
| Secondary identifying numbers | N0355127318 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 14/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Karen MacKrodt
Scientific
Scientific
Mid Essex Hospital Services NHS Trust
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Back pain |
| Intervention | Patients referred via the three chronic pain consultants will be entered into the study if fitting the inclusion criteria. A trial of two therapies: conventional TENS using a programmable machine and a specific programme for 2 hours three 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 25 for TENS and 25 for magnet therapy |
| Key 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) |
| Key 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 has not been clinically proven). |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mid Essex Hospital Services NHS Trust
Chelmsford
CM1 7ET
United Kingdom
CM1 7ET
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Mid Essex Hospital Services NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
