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

ISRCTN	ISRCTN61808774
DOI	https://doi.org/10.1186/ISRCTN61808774
Secondary identifying numbers	M0001078851

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 28/03/2018

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

Dr Paul Thomas
Scientific

Kilburn Park Medical Centre
12 Cambridge Gardens
Kilburn
London
NW6 5AY
United Kingdom

Phone	+44 (0)20 7624 2414
Email	p.r.thomas@imperial.ac.uk

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	A randomised controlled trial of the effect on chronic low back pain of a naturopathic osteopathy intervention
Study objectives	Does a naturopathic osteopathy intervention improve pain, disability and sense of well being in chronic low back pain?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2000
Completion date	01/06/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	240
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/04/2000
Date of final enrolment	01/06/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Kilburn Park Medical Centre

London
NW6 5AY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Research organisation

The West London Research Network (WeLReN) (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

Editorial Notes

28/03/2018: No publications found, verifying study status with principal investigator.
09/02/2016: No publications found, study status unverified.