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
Protocol serial number	M0001078851
Sponsor	Department of Health (UK)
Funder	The West London Research Network (WeLReN) (UK)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/06/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Kilburn Park Medical Centre

London
NW6 5AY
United Kingdom

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

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