Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001588482
Ethics application status
Approved
Date submitted
13/11/2016
Date registered
17/11/2016
Date last updated
17/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of six-week Pilates-based exercise on chronic low back pain and related functional disability
Scientific title
Effect of six-week Pilates-based exercise on pain and functional disability in people with chronic or recurrent low back pain
Secondary ID [1] 290531 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 300952 0
Condition category
Condition code
Musculoskeletal 300748 300748 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300749 300749 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two 60 min Pilates-based movement control and body awareness small group classes per week for 6 weeks held in a private studio. One class each week mat based and one reformer based. All classes supervised by trained exercise practitioner (Pilates instructor with 5 years' experience). A record was kept of participant attendance and additional "make-up" sessions were allowed to maximise compliance.
Intervention code [1] 296381 0
Rehabilitation
Intervention code [2] 296382 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300168 0
Pain Intensity (via 11-point numeric pain rating scale)
Timepoint [1] 300168 0
7 weeks
Primary outcome [2] 300169 0
Functional Disability (via Patient Specific Functional Scale)
Timepoint [2] 300169 0
7 weeks
Primary outcome [3] 300170 0
Modified Oswestry Disability Index
Timepoint [3] 300170 0
7 weeks
Secondary outcome [1] 329233 0
Troublesomeness Scale
Timepoint [1] 329233 0
7 weeks
Secondary outcome [2] 329234 0
Fingertip to Floor Flexibility
Timepoint [2] 329234 0
7 weeks
Secondary outcome [3] 329235 0
Forward Bending Flexibility (via Schober's Index)
Timepoint [3] 329235 0
7 weeks

Eligibility
Key inclusion criteria
Current low back pain of at least 6 months duration OR
Current low back pain of less than 6 months duration with repeated pain episodes in the last year
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nerve root compression signs including leg pain to the knee or below
Recent (last 12 months) spinal fracture, spinal tumour or spinal infection
Abdominal or spinal surgery in last 12 months
Osteoporosis
Pregnancy (known or expected/anticipated)
Co-morbidities or contraindications to exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Paired-samples t-tests for normally distributed variables
Wilcoxin signed ranks test otherwise

Multiple regression models used to determine predictors of success and failure of the intervention
Receiver operating characteristic (ROC) curves and follow-up Chi-square tests used to develop clinical prediction rules for success and failure of the intervention

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/04/2009
Date of last participant enrolment
Anticipated
Actual
4/07/2009
Date of last data collection
Anticipated
Actual
11/09/2009
Sample size
Target
53
Accrual to date
Final
55
Recruitment outside Australia
Country [1] 8388 0
New Zealand
State/province [1] 8388 0
Auckland

Funding & Sponsors
Funding source category [1] 294959 0
University
Name [1] 294959 0
Unitec Institute of Technology
Country [1] 294959 0
New Zealand
Primary sponsor type
University
Name
Unitec Institute of Technology
Address
Private Bag 92025
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293779 0
Individual
Name [1] 293779 0
Robert W. Moran
Address [1] 293779 0
Unitec Institute of Technology
Private Bag 92025
Auckland 1142
Country [1] 293779 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296321 0
Unitec Research Ethics Committee
Ethics committee address [1] 296321 0
Ethics committee country [1] 296321 0
New Zealand
Date submitted for ethics approval [1] 296321 0
04/03/2009
Approval date [1] 296321 0
03/04/2009
Ethics approval number [1] 296321 0
2009-923

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70430 0
Mr Robert W. Moran
Address 70430 0
Unitec Institute of Technology
Private Bag 92025
Auckland 1142
Country 70430 0
New Zealand
Phone 70430 0
+64 (0) 9 892 8197
Fax 70430 0
Email 70430 0
[email protected]
Contact person for public queries
Name 70431 0
Robert W. Moran
Address 70431 0
Unitec Institute of Technology
Private Bag 92025
Auckland 1142
Country 70431 0
New Zealand
Phone 70431 0
+64 (0) 9 892 8197
Fax 70431 0
Email 70431 0
[email protected]
Contact person for scientific queries
Name 70432 0
Robert W. Moran
Address 70432 0
Unitec Institute of Technology
Private Bag 92025
Auckland 1142
Country 70432 0
New Zealand
Phone 70432 0
+64 (0) 9 892 8197
Fax 70432 0
Email 70432 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePredictors of functional improvement in people with chronic low back pain following a graded Pilates-based exercise programme.2019https://dx.doi.org/10.1016/j.jbmt.2018.06.007
N.B. These documents automatically identified may not have been verified by the study sponsor.