Trial registered on ANZCTR


Trial ID
ACTRN12605000053628
Ethics application status
Approved
Date submitted
28/07/2005
Date registered
29/07/2005
Date last updated
29/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of exercise and spinal manipulative therapy for chronic LBP
Scientific title
A comparison of the effects of spinal manipulative therapy versus exercise on pain and disability in subjects with chronic LBP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic LBP 124 0
Condition category
Condition code
Alternative and complementary medicine 139 139 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled trial with 240 subjects randomised to one of three groups(i) spinal manipulative therapy (max 12 sessions)
(ii) general exercise (12 sessions over 8 weeks)
(iii) specific stabilisation exercises (12 sessions over 8 weeks
Intervention code [1] 76 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 179 0
Disability
Timepoint [1] 179 0
Measured at 8 wks, 6 & 12 months
Primary outcome [2] 180 0
Pain
Timepoint [2] 180 0
Measured at 8 wks, 6 & 12 months
Secondary outcome [1] 384 0
Global Perceived Effect
Timepoint [1] 384 0
8 wks, 6 & 12 months.
Secondary outcome [2] 385 0
Generic disability measure
Timepoint [2] 385 0
8 wks, 6 & 12 months.

Eligibility
Key inclusion criteria
Non specific LBP of greater than 3 months duration
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Spinal surgery past 12 months, suspected or diagnosed serious spinal pathology, nerve root compromise, contraindications to exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered, sealed opaque envelope to conceal allocation from the referring physiotherapist and the trial staff member determining eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation schedule generated by computer with blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 192 0
Charities/Societies/Foundations
Name [1] 192 0
Arthritis Foundation
Address [1] 192 0
Country [1] 192 0
Australia
Funding source category [2] 193 0
Government body
Name [2] 193 0
Motor Accidents Authority
Address [2] 193 0
Country [2] 193 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 143 0
None
Name [1] 143 0
Nil
Address [1] 143 0
Country [1] 143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 954 0
Liverpool and Westmead Hospitals
Ethics committee address [1] 954 0
Ethics committee country [1] 954 0
Australia
Date submitted for ethics approval [1] 954 0
Approval date [1] 954 0
Ethics approval number [1] 954 0

Summary
Brief summary
Low back pain affects most people at some stage in their life and is a major cause of chronic absenteeism and disability. Three common treatments for chronic LBP are spinal manipulative therapy, general exercise, and specific stabilisation exercise. While there is evidence that they are effective, to date there has been no head to head comparison of these treatments. We propose to conduct a definitive trial to investigate the effects of these interventions in a population suffering from chronic low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35975 0
Address 35975 0
Country 35975 0
Phone 35975 0
Fax 35975 0
Email 35975 0
Contact person for public queries
Name 9265 0
Dr Jane Latimer
Address 9265 0
School of Physiotherapy
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 9265 0
Australia
Phone 9265 0
+61 2 93519191
Fax 9265 0
Email 9265 0
J.Latimer@fhs.usyd.edu.au
Contact person for scientific queries
Name 193 0
Associate Professor Chris Maher
Address 193 0
School of Physiotherapy
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 193 0
Australia
Phone 193 0
+61 2 93519192
Fax 193 0
Email 193 0
C.Maher@fhs.usyd.edu.au