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Trial registered on ANZCTR


Registration number
ACTRN12609000536268
Ethics application status
Approved
Date submitted
28/06/2009
Date registered
3/07/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Clinical Pilates versus general exercise for chronic low back pain: a randomised controlled trial.
Scientific title
Effect on low back function of Clinical Pilates versus general exercise in adults with chronic low back pain
Secondary ID [1] 252114 0
Effect on chronic low back pain and function of Clinical Pilates
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 237107 0
Condition category
Condition code
Musculoskeletal 237435 237435 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with chronic low back pain will be screened via telephone and undergo a physical screening. Baseline testing will be performed at The University of Melbourne and the participant randomised into one of two groups (i) Clinical Pilates (ii) General Exercise. the intervention will last for 6 weeks after which all participants will be reassessed by the same blinded assessor. Both interventions will comprise 12X1 hour visits for supervised exercise over 6 weeks (2 per week) to the trial clinic plus home exercises daily. The supervised sessions will be conducted by a physiotherapist in small group format with up to four participants. An exercise diary will be kept and monitored by the supervising physiotherapist. The Clinical Pilates programs are tailor-made Pilates exercises based on a history and physical assessment. The exercises are chosen according to findings on assessment and are performed on pilates equipment, with home exercises prescribed as an adjunct to the equipment-based exercises.
Intervention code [1] 236827 0
Treatment: Other
Comparator / control treatment
The general exercise program is a standardised set of exercises including exercise bike, abdominal, back and limb strengthening using weights, exercise ball and theraband tubing.
Control group
Active

Outcomes
Primary outcome [1] 238232 0
Quebec Low back Pain questionnaire
Timepoint [1] 238232 0
Baseline and 6 weeks following randomisation, with follow up at 3 months and 6 months following completion of (6 week) program
Secondary outcome [1] 244643 0
Low Back pain with a Visual Analogue Scale (VAS)
Timepoint [1] 244643 0
Baseline and 6 weeks following randomisation, with follow up at 3 months and 6 months following completion of (6 week) program
Secondary outcome [2] 244644 0
Function with a Patient Specific Functional Scale (PSFS)
Timepoint [2] 244644 0
Baseline and 6 weeks following randomisation, with follow up at 3 months and 6 months following completion of (6 week) program
Secondary outcome [3] 244645 0
Quality of Life with a 36-Item Short-Form Health Survey (SF 36)
Timepoint [3] 244645 0
Baseline and 6 weeks following randomisation, with follow up at 3 months and 6 months following completion of (6 week) program
Secondary outcome [4] 244646 0
Self Efficacy with a Pain Self Efficacy Questionnaire
Timepoint [4] 244646 0
Baseline and 6 weeks following randomisation, with follow up at 3 months and 6 months following completion of (6 week) program
Secondary outcome [5] 244647 0
Saggital Spinal Posture and Range of Motion with a Digital Dual Inclinometer
Timepoint [5] 244647 0
Baseline and 6 weeks following randomisation

Eligibility
Key inclusion criteria
Low back pain with or without leg pain on most days for the last three months, pain greater than 4/10,
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Back Surgery, Spinal Infection, Fractures , Osteoporosis, Hip Osteoarthritis, Ankylosing Spondylitis, Rheumatoid Arthritis, Low back pain of non-musculoskeletal origin, Workcover, Transport Accident Commission or legal claim, Pregnancy, Acute disc prolapse, treatment involving exercise in the last six months

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)
After screening procedures, eligible volunteers allocated to a group at random. Sealed opaque envelopes kept in central location and opened after baseline testing by administrator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation , computer generated random number list. Variable block sizes will be used , stratified for age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Independent blinded assessor
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 237218 0
Commercial sector/Industry
Name [1] 237218 0
DMA Clinical Pilates
Address [1] 237218 0
1 Yarra Street South Yarra Victoria 3141
Country [1] 237218 0
Australia
Primary sponsor type
Individual
Name
Henry Wajswelner
Address
Centre for Health Exercise and Sports Medicine, Melbourne Physiotherapy School, The University of Melbourne 200 Berkeley Street Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 4710 0
Individual
Name [1] 4710 0
Professor Kim Bennell
Address [1] 4710 0
Centre for Health Exercise and Sports Medicine, Melbourne Physiotherapy School, The University of Melbourne 200 Berkeley Street Carlton VIC 3053
Country [1] 4710 0
Australia
Other collaborator category [1] 728 0
Individual
Name [1] 728 0
Mr Tim Wrigley
Address [1] 728 0
Centre for Health Exercise and Sports Medicine, Melbourne Physiotherapy School, The University of Melbourne 200 Berkeley Street Carlton VIC 3053
Country [1] 728 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239316 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 239316 0
Melbourne Research Office
The University of Melbourne
Level 5, Alan Gilbert Building
VIC 3010
Ethics committee country [1] 239316 0
Australia
Date submitted for ethics approval [1] 239316 0
16/06/2009
Approval date [1] 239316 0
24/06/2009
Ethics approval number [1] 239316 0
0931800

Summary
Brief summary
In people with chronic low back pain, a randomised controlled trial comparing the effect of a six week clinical pilates program with a general exercise program on back function with a 3 and 6 month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29805 0
Address 29805 0
Country 29805 0
Phone 29805 0
Fax 29805 0
Email 29805 0
Contact person for public queries
Name 13052 0
Henry Wajswelner
Address 13052 0
617 Canning street North Carlton VIC 3054
Country 13052 0
Australia
Phone 13052 0
+61 3 93889387
Fax 13052 0
Email 13052 0
waj5@me.com
Contact person for scientific queries
Name 3980 0
Henry Wajswelner
Address 3980 0
617 Canning street North Carlton VIC 3054
Country 3980 0
Australia
Phone 3980 0
+61 428292265
Fax 3980 0
Email 3980 0
waj5@me.com

No information has been provided regarding IPD availability
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