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Trial registered on ANZCTR


Registration number
ACTRN12606000151538
Ethics application status
Approved
Date submitted
27/04/2006
Date registered
2/05/2006
Date last updated
20/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Swiss Ball Exercise versus Floor Exercise for patients with chronic low back pain: Effect on Trunk Muscle Endurance and Control of Lumbopelvic Posture
Scientific title
Swiss Ball exercise versus floor exercise for patients with chronic low back pain: Effect on Trunk Muscle Endurance and Control of Lumbopelvic Posture
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chonic low back pain 1123 0
Chronic low back pain 2235 0
New health condition. Please modify. 2236 0
Condition category
Condition code
Musculoskeletal 1201 1201 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Swiss ball exercise group: Supervised exercise training using the Swiss ball, 45 minutes per session, 3 times/week for 8 weeks
Intervention code [1] 1004 0
Rehabilitation
Intervention code [2] 1945 0
Other interventions
Intervention code [3] 1946 0
Other interventions
Comparator / control treatment
Floor exercise group: Supervised floor-based exercise training, 45 minutes per session, 3 times/week for 8 weeks
Control group
Active

Outcomes
Primary outcome [1] 1629 0
Trunk muscle endurance
Timepoint [1] 1629 0
Assessed at baseline and within 7 days of completion of the intervention.
Primary outcome [2] 1630 0
Control of lumbopelvic posture
Timepoint [2] 1630 0
Assessed at baseline and within 7 days of completion of the intervention.
Secondary outcome [1] 2921 0
Roland-Morris questionnaire
Timepoint [1] 2921 0
Administered at baseline and within 7 days of completion of the intervention.
Secondary outcome [2] 2922 0
Patient-specific functional scale
Timepoint [2] 2922 0
Administered at baseline and within 7 days of completion of the intervention.
Secondary outcome [3] 2923 0
Pain VAS scale
Timepoint [3] 2923 0
Administered at baseline and within 7 days of completion of the intervention.
Secondary outcome [4] 2924 0
International Physical Activity questionnaire
Timepoint [4] 2924 0
Administered at baseline and within 7 days of completion of the intervention.

Eligibility
Key inclusion criteria
Non-specific low back pain with the current episode lasting for at least 3 months duration but no longer than one year and the pain is present for at least 50% of the time; expects to continue residing in the Illawara region for study duration.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspected or confirmed serious spinal pathology; suspected or confirmed pregnancy; previous spinal surgery; scheduled for major surgery during treatment or follow-up period; high blood pressure; known cardiovascular disease.

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)
Allocation to group is done via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by computer program. No stratification.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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] 1314 0
University
Name [1] 1314 0
University of Sydney
Address [1] 1314 0
Camperdown
Country [1] 1314 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown
Country
Australia
Secondary sponsor category [1] 1161 0
None
Name [1] 1161 0
nil
Address [1] 1161 0
Country [1] 1161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2643 0
University of Sydney
Ethics committee address [1] 2643 0
Ethics committee country [1] 2643 0
Australia
Date submitted for ethics approval [1] 2643 0
Approval date [1] 2643 0
13/12/2005
Ethics approval number [1] 2643 0
12-2005/1/8753

Summary
Brief summary
The aim of this study is to compare the efficacy of two commonly used clinical exercise interventions for patients with chronic low pain; Swiss ball exercise and floor-based exercise. We hypothesise that there will be no difference between the two exercise programs in terms of improving trunk muscle endurance and lumbopelvic posture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35521 0
Address 35521 0
Country 35521 0
Phone 35521 0
Fax 35521 0
Email 35521 0
Contact person for public queries
Name 10193 0
Jacqui Raymond
Address 10193 0
School of Exercise and sport Science
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 10193 0
Australia
Phone 10193 0
+61 2 9351 9528
Fax 10193 0
Email 10193 0
J.Raymond@fhs.usyd.edu.au
Contact person for scientific queries
Name 1121 0
Dr Jacqui Raymond
Address 1121 0
School of Exercise and sport Science
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 1121 0
Australia
Phone 1121 0
+61 2 9351 9528
Fax 1121 0
Email 1121 0
J.Raymond@fhs.usyd.edu.au

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