Condition category
Musculoskeletal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Karen MacKrodt

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0355127318

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2003

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

25 for TENS and 25 for magnet therapy

Participant 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).

Recruitment start date

01/08/2003

Recruitment end date

30/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Mid Essex Hospital Services NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes