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
Protocol serial number	N0355127318
Sponsor	Department of Health
Funder	Mid Essex Hospital Services NHS Trust (UK)

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

Mid Essex Hospital Services NHS Trust
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	50
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

United Kingdom
England

Study participating centre

Mid Essex Hospital Services NHS Trust

Chelmsford
CM1 7ET
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan