Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
09/02/2016
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

Dr Paul Thomas

ORCID ID

Contact details

Kilburn Park Medical Centre
12 Cambridge Gardens
Kilburn
London
NW6 5AY
United Kingdom
+44 (0)20 7624 2414
p.r.thomas@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M0001078851

Study information

Scientific title

A randomised controlled trial of the effect on chronic low back pain of a naturopathic osteopathy intervention

Acronym

Study hypothesis

Does a naturopathic osteopathy intervention improve pain, disability and sense of well being in chronic low back 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

Questionnaire inquiry of disability, pain and sense of well being administered at recruitment, 3, 6, 12 months, and at 5 years. Half will be randomised to an intervention arm that comprises treatment at the British College of Naturopathy and Osteopathy (BCNO) by third/fourth year students under the supervision of experienced trainer practitioners. This intervention will be naturopathic osteopathy and include patient diaries. Up to seven treatments will be given, expecting an average of five weekly treatments.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Assessment of:
1. Disability using the Roland Morris Score
2. Self competence using the Perceived Pain Management Competence Scale
3. Beliefs using the Back Beliefs Questionnaire
4. Pain using the Von Korff questionnaire
5. Well-being using the SF12.

All of these are self-administered questionnaires.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2000

Overall trial end date

01/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

240 clients aged between 20 and 65 presenting at ten general practices in Brent in the summer of 2000 with low back pain of over three months duration. Random allocation to an intervention arm and usual care.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/2000

Recruitment end date

01/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kilburn Park Medical Centre
London
NW6 5AY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Research organisation

Funder name

The West London Research Network (WeLReN) (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

09/02/2016: No publications found, study status unverified.