Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LBPT01
Study information
Scientific title
Acronym
NCLBP
Study hypothesis
Will naturopathic care including acupuncture, diet counselling, and deep breathing be equally or more effective than a physiotherapy equivalent?
Ethics approval
Internal Review Board of The Canandian College of Naturopathic Medicine. Obtained in January 2005.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Chronic low back pain
Intervention
Active: acupuncture, dietary counseling, relaxation exercises
Control: education on physiotherapy exercises
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Oswestry, Roland and Morris Disability Questionnaire
Secondary outcome measures
1. Short Form health survey (SF-36)
2. Spinal Forward Flexion
3. Medication and adjunctive treatment usage
Overall trial start date
01/01/2005
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
01/09/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Department of Clinical Epidemiology
Toronto
M2K 1E2
Canada
Sponsor information
Organisation
The Canadian College of Naturopathic Medicine (Canada)
Sponsor details
1255 Sheppard Ave E.
Toronto
M2K 1E2
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canada Post Corporation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canadian Union of Postal Workers
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Canadian College of Naturopathic Medicine
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
Results on http://www.plosone.org/article/fetchArticle.action?articleURI=info:doi/10.1371/journal.pone.0000919