Condition category
Musculoskeletal Diseases
Date applied
19/12/2006
Date assigned
16/01/2007
Last edited
19/09/2007
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 Edward Mills

ORCID ID

Contact details

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

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

http://www.ccnm.edu/

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

Publication citations

Additional files

Editorial Notes