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ISRCTN
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ISRCTN56847801
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ClinicalTrials.gov identifier
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Public title
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A comparative study of static magnetic field (SMF) therapy against Transcutaneous Electrical Nerve Stimulation (TENS) therapy on mechanical back pain and neck pain.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0355127318
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Musculoskeletal Diseases: Back pain
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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).
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Anticipated start date
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01/08/2003
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Anticipated end date
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30/04/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Mid Essex Hospital Services NHS Trust
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Trial website
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Publications
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Contact name
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Ms
Karen
MacKrodt
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Address
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Mid Essex Hospital Services NHS Trust
Broomfield Hospital
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City/town
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Chelmsford
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Zip/Postcode
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CM1 7ET
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Country
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United Kingdom
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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21/11/2005
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Date ISRCTN assigned
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30/09/2004
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