Naturopathic Care for Low Back Pain: a randomised controlled trial

ISRCTN	ISRCTN41920953
DOI	https://doi.org/10.1186/ISRCTN41920953
Protocol serial number	LBPT01
Sponsor	The Canadian College of Naturopathic Medicine (Canada)
Funders	Canada Post Corporation, Canadian Union of Postal Workers, The Canadian College of Naturopathic Medicine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Edward Mills
Scientific

Department of Clinical Epidemiology
The Canadian College of Naturopathic Medicine
1255 Sheppard Ave. E.
Toronto
M2K 1E2
Canada

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	NCLBP
Study objectives	Will naturopathic care including acupuncture, diet counselling, and deep breathing be equally or more effective than a physiotherapy equivalent?
Ethics approval(s)	Internal Review Board of The Canandian College of Naturopathic Medicine. Obtained in January 2005.
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	Active: acupuncture, dietary counseling, relaxation exercises Control: education on physiotherapy exercises
Intervention type	Other
Primary outcome measure(s)	Oswestry, Roland and Morris Disability Questionnaire
Key secondary outcome measure(s)	1. Short Form health survey (SF-36) 2. Spinal Forward Flexion 3. Medication and adjunctive treatment usage
Completion date	01/09/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	75
Key inclusion criteria	1. Mentally competent volunteers 18 to 65, male or female 2. Low back pain of more than six weeks duration 3. Normal on physical examination at the pre-study physical
Key exclusion criteria	1. History of spinal operations 2. Current history of herniated disk 3. Current history of systemic rheumatological disease, ankylosing spondylitis, tumors, infection 4. Pregnancy
Date of first enrolment	01/01/2005
Date of final enrolment	01/09/2005

Department of Clinical Epidemiology

Toronto
M2K 1E2
Canada

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	19/09/2007		Yes	No