The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000036617
Ethics application status
Approved
Date submitted
22/07/2005
Date registered
22/07/2005
Date last updated
5/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical trial of manipulative therapy and/or NSAIDs for significant acute low back pain
Scientific title
A randomised controlled trial to evaluate the effect of spinal manipulative therapy and/or NSAIDs on time to recovery of pain for patients with acute low back pain who have received general practitioner advice and paracetamol
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute low back pain 99 0
Condition category
Condition code
Alternative and Complementary Medicine 120 120 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study group 1: NSAIDs (Diclofenac 50 mg bd) and spinal manipulative therapy for up to 4 weeks
Study group 2: NSAIDs (Diclofenac 50 mg bd) and placebo spinal manipulative therapy for up to 4 weeks
Study group 3: Placebo NSAIDs and spinal manipulative therapy for up to 4 weeks
Intervention code [1] 47 0
Treatment: Other
Comparator / control treatment
Control group: Placebo NSAIDs and placebo spinal manipulative therapy for up to 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 151 0
The primary outcome is the number of days to recovery with recovery defined in two ways. Firstly recovery is defined as a pain score of 0 or 1 on a 0-10 pain scale (numerical pain rating scale) that is maintained for seven consecutive days. Secondly recovery is defined as the first day that the patient has a pain score or 0 or 1 on a 0 to 10 pain scale.
Timepoint [1] 151 0
Secondary outcome [1] 332 0
Pain
Timepoint [1] 332 0
Measured at baseline, 1 week, 2 weeks, 4 weeks and 3 months
Secondary outcome [2] 333 0
Disability
Timepoint [2] 333 0
Measured at baseline, 1 week, 2 weeks, 4 weeks and 3 months
Secondary outcome [3] 334 0
Global perceived effect and satisfaction/beliefs about treatment.
Timepoint [3] 334 0
Measured at baseline, 1 week, 2 weeks, 4 weeks and 3 months

Eligibility
Key inclusion criteria
1) Primary complaint of pain extending in an area between the 12th rib and buttock crease. This may or may not be accompanied by leg pain. 2) New episode of low back pain. 3) Pain of less than 6 weeks duration (in accordance with the Cochrane Collaboration Back Review Group definition for acute pain). 4) Low back pain severe enough to cause moderate pain and moderate interference with normal work including work outside the home and housework (as measured by adaptations of items 7 and 8 of the SF-36).
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) known or suspected serious spinal pathology (metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture). 2) nerve root compromise evidenced by at least two of the following (i) myotomal weakness, (ii) dermatomal or widespread sensory loss, (iii) hypo or hyperreflexia of the lower limb reflexes; 3) currently taking NSAIDs. 4) currently receiving SMT. 5) spinal surgery within the preceding 6 months; 6) history of peptic ulcer; 7) allergy to aspirin; 8) currently receiving anticoagulant therapy; 9) serious co-morbidities preventing prescription of NSAIDs or paracetamol eg: cardiac, liver or renal failure

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
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] 165 0
Government body
Name [1] 165 0
NHMRC project grant
Address [1] 165 0
Country [1] 165 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 120 0
University
Name [1] 120 0
Back Pain Research Group, University of Sydney
Address [1] 120 0
Country [1] 120 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 911 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 911 0
Ethics committee country [1] 911 0
Australia
Date submitted for ethics approval [1] 911 0
Approval date [1] 911 0
01/03/2005
Ethics approval number [1] 911 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Hancock MJ, Maher CG, Latimer J, McLachlan AJ, Cooper CW, Day RO, Spindler MF and McAuley JH (2007). Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial. Lancet 370: 1638-1643

Hancock MJ, Maher CG, Latimer J, McLachlan AJ, Cooper CW, Day RO, Spindler MF and McAuley JH (2005). Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617]. BMC Musculoskeletal Disorders. 6:57

Public notes

Contacts
Principal investigator
Name 35984 0
Address 35984 0
Country 35984 0
Phone 35984 0
Fax 35984 0
Email 35984 0
Contact person for public queries
Name 9236 0
Mr Mark Hancock
Address 9236 0
School of Physiotherapy
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 9236 0
Australia
Phone 9236 0
+61 2 93519671
Fax 9236 0
+61 2 93519681
Email 9236 0
M.Hancock@fhs.usyd.edu.au
Contact person for scientific queries
Name 164 0
Associate Professor Chris Maher
Address 164 0
School of Physiotherapy
University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 164 0
Australia
Phone 164 0
+61 2 93519192
Fax 164 0
+61 2 93519681
Email 164 0
C.Maher@fhs.usyd.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary