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Trial registered on ANZCTR


Registration number
ACTRN12610000523000
Ethics application status
Approved
Date submitted
24/06/2010
Date registered
24/06/2010
Date last updated
24/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of the addition of the Pilates Method over a minimal intervention on disability, kinesiofobia, pain intensity and global-perceived effect in patients with chronic non-specific low back pain: A randomised controlled trial.
Scientific title
The efficacy of the addition of the Pilates Method over a minimal intervention on disability, kinesiofobia, pain intensity and global-perceived effect in patients with chronic non-specific low back pain: A randomised controlled trial.
Secondary ID [1] 252093 0
not applicable
Universal Trial Number (UTN)
U1111-1115-6077
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 257640 0
Condition category
Condition code
Musculoskeletal 257818 257818 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilates Group + Minimal intervention

Patients allocated to the Pilates group will receive specific exercises based upon the Pilates method. The Pilates version that will be used on this study will be the "Mat Pilates version" which consists of all usual Pilates exercises performed on a mat (i.e. no special equipment will be used). The patients will receive individualised treatment for 1 hour a day, twice a week over six weeks (i.e. 12 sessions of treatment in total). The progression of the exercises will be performed on an individual basis, based upon the patient´s presentation.

These patients will also receive all components of the minimal intervention group as described below:

Patients will receive instructions from a booklet that contains information on low back pain, anatomy of the lumbar spine and pelvis plus advice on posture and movements related to activities of daily living.
Intervention code [1] 256716 0
Treatment: Other
Comparator / control treatment
Minimal intervention

Patients allocated to the minimal intervention group will receive instructions from a booklet that contains information on low back pain, anatomy of the lumbar spine and pelvis plus advice on posture and movements related to activities of daily living.
Control group
Active

Outcomes
Primary outcome [1] 258679 0
Pain Intensity measured by the Pain Numerical Rating Scale
Timepoint [1] 258679 0
Baseline, 6 weeks and 6 months
Primary outcome [2] 258680 0
Disability measured by the Roland Morris Disability Questionnaire
Timepoint [2] 258680 0
Baseline, 6 weeks and 6 months
Secondary outcome [1] 264688 0
Function measured by the Patient-Specific Functional Scale
Timepoint [1] 264688 0
Baseline, 6 weeks and 6 months
Secondary outcome [2] 264689 0
Kinesiophobia measured by the Tampa Scale of Kinesiophobia
Timepoint [2] 264689 0
Baseline, 6 weeks and 6 months
Secondary outcome [3] 264690 0
Global Perceived Effect measured by the Global Perceived Effect Scale
Timepoint [3] 264690 0
Baseline, 6 weeks and 6 months

Eligibility
Key inclusion criteria
Low back pain longer than three months
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy, contra-indications to exercise, nerve root compromise and serious spinal pathology

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation schedule generated by computer (Excel for Windows).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment outside Australia
Country [1] 2722 0
Brazil
State/province [1] 2722 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257194 0
Self funded/Unfunded
Name [1] 257194 0
Country [1] 257194 0
Brazil
Primary sponsor type
Individual
Name
Cristina Cabral
Address
Masters in Physical Therapy Program - Universidade Cidade de Sao Paulo (UNICID)
Brazil Rua Cesario Galeno 448 Tatuape Sao Paulo CEP 03071-000
Country
Brazil
Secondary sponsor category [1] 256448 0
University
Name [1] 256448 0
UNICID Universidade Cidade de Sao Paulo
Address [1] 256448 0
Rua Cesario Galeno 448 Tatuape Sao Paulo CEP 03071-000
Country [1] 256448 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259222 0
Comite de etica em pesquisa (CEP) UNICID
Ethics committee address [1] 259222 0
Ethics committee country [1] 259222 0
Brazil
Date submitted for ethics approval [1] 259222 0
Approval date [1] 259222 0
21/06/2010
Ethics approval number [1] 259222 0
13508130

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

Contacts
Principal investigator
Name 31332 0
Address 31332 0
Country 31332 0
Phone 31332 0
Fax 31332 0
Email 31332 0
Contact person for public queries
Name 14579 0
Cristina Cabral
Address 14579 0
Rua Cesario Galeno 448 Tatuape Sao Paulo CEP 03071-000
Country 14579 0
Brazil
Phone 14579 0
+551121781479
Fax 14579 0
Email 14579 0
ccabral@edu.unicid.br
Contact person for scientific queries
Name 5507 0
Cristina Cabral
Address 5507 0
Rua Cesario Galeno 448 Tatuape Sao Paulo CEP 03071-000
Country 5507 0
Brazil
Phone 5507 0
+551121781479
Fax 5507 0
Email 5507 0
ccabral@edu.unicid.br

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
No additional documents have been identified.