Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000927224
Ethics application status
Approved
Date submitted
21/10/2009
Date registered
28/10/2009
Date last updated
28/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilates and the effectiveness of the transversus abdominis in the individuals with low back pain
Scientific title
Pilates and the effectiveness of the transversus abdominis in the individuals with low back pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 251982 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252173 252173 0 0
Physiotherapy
Musculoskeletal 252274 252274 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research included 16 individuals (9 men and 7 women) with mechanical low back pain and age between 30 and 60 years. To increase the force of the muscle transverso was used the Pilates method.
They practiced 10 sessions of one hour of Pilates twice a week for 5 straight weeks.The effectiveness contraction of the Transversus Abdominis was evaluated through the Chattanooga Stabilizer Pressure Biofeedback for the test contraction of transversus abdominis, each individual was placed in the prone position with the arms beside the body and the stock pressure on the abdomen, navel located in the pouch and the anterior iliac spine and right upper lined the edge of the same. First, was held to familiarize the subject with the test run. The cushion was inflated to 70 mmHg which is considered the unit of pressure biofeedback. With the weight of abdominal contents on the cushion, the subjects were instructed to remove the most of your lower abdomen at the expiration of the pad without any movement of the pelvis or torso. Started normal expiration during the act of removal, the contraction was held for 10s. A successful performance test reduces the pressure of 6-10mmHg, indicating the correct localized contraction of transversus abdominis, independently of the other abdominal muscles. A depression of 6 mmHg, no change or an increase in pressure indicates an ineffective contraction of the transversus abdominis.
The level of functional capacity for the Oswestry Disability Index and the quality of life for the Short Form-36 (SF-36). Two evaluations were accomplished, before and after 10 Pilates session
Intervention code [1] 241394 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253068 0
effectiveness contraction of the Transversus Abdominis muscle will be assessed through the Chattanooga Stabilizer Pressure Biofeedback. A successful performance test reduces the pressure of 6-10mmHg, indicating the correct localized contraction of transversus abdominis, independently of the other abdominal muscles. A depression of 6 mmHg, no change or an increase in pressure indicates an ineffective contraction of the transversus abdominis
Timepoint [1] 253068 0
This outcome will also be assessed at baseline and after 10 sessions intervention
Primary outcome [2] 253069 0
level of functional capacity for the Oswestry Disability Index
Timepoint [2] 253069 0
This outcome will also be assessed at baseline and after 10 sessions intervention
Primary outcome [3] 253070 0
level of quality of life for the Short Form-36 (SF-36).
Timepoint [3] 253070 0
This outcome will also be assessed at baseline and after 10 sessions intervention
Secondary outcome [1] 257907 0
"Nil"
Timepoint [1] 257907 0
"Nil"

Eligibility
Key inclusion criteria
people with low back pain, to practised 10 sessions of one hour of the Pilates method, two times per week, during 5 weeks consecutive, to be beginning in the method
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
to carry through another treatment conservative or medicament for low back pain, to have been submitted to the previous surgery in the lumbar region, to present neurological injuries with damage of the cognitiva function

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



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2262 0
Brazil
State/province [1] 2262 0
Santa Catarina

Funding & Sponsors
Funding source category [1] 243908 0
University
Name [1] 243908 0
Universidade do Estado de Santa Catarina
Country [1] 243908 0
Brazil
Primary sponsor type
Individual
Name
Nicole Thays Albino
Address
Rua Pref. Dib Cherem, 2881 Ap. 303
Capoeiras – Florianopolis – Santa Catarina
CEP 88090-000
Country
Brazil
Secondary sponsor category [1] 251253 0
Individual
Name [1] 251253 0
Micheline Henrique Araujo da Luz koerich
Address [1] 251253 0
Paschoal Simone, 358 - Coqueiros
Florianopolis - Estado de Santa Catarina - 88080350
Country [1] 251253 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244049 0
Ethics Committee of Santa Catarina State
Ethics committee address [1] 244049 0
Universidade do Estado de Santa Catarina - Av. Madre Benvenuta, 2007 - Itacorubi - 88.035-001 - Florianopolis - SC
Ethics committee country [1] 244049 0
Brazil
Date submitted for ethics approval [1] 244049 0
Approval date [1] 244049 0
Ethics approval number [1] 244049 0

Summary
Brief summary
Background: Low back pain has become a social-economic and public health problem. It has been related with the weakness of lumbar column muscles and the Transversus Abdominis can be characterized as the main component of this group for the lumbar spine stability. Objectives: Identifying the effects of the Pilates Method on the effectiveness contraction of the Transversus Abdominis muscle, on the functional capacity and on the quality of life in people with low back pain. Methods: The research included 16 individuals (9 men and 7 women) with mechanical low back pain and age between 30 and 60 years. The effectiveness contraction of the Transversus Abdominis was evaluated through the Chattanooga Stabilizer Pressure Biofeedback, the level of functional capacity for the Oswestry Disability Index and the quality of life for the Short Form-36 (SF-36). Two evaluations were accomplished, before and after 10 Pilates session and the data had been submitted the statistics analysis with level of significance of a = 0,05
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30372 0
Address 30372 0
Country 30372 0
Phone 30372 0
Fax 30372 0
Email 30372 0
Contact person for public queries
Name 13619 0
Nicole Thays Albino
Address 13619 0
Nicole Thays Albino
Rua Pref. Dib Cherem, 2881 Ap. 303
Capoeiras – Florianopolis – Santa Catarina
CEP 88090-00
Country 13619 0
Brazil
Phone 13619 0
55(48)32487663
Fax 13619 0
Email 13619 0
[email protected]
Contact person for scientific queries
Name 4547 0
Nicole Thays Albino
Address 4547 0
Nicole Thays Albino
Rua Pref. Dib Cherem, 2881 Ap. 303
Capoeiras – Florianopolis – Santa Catarina
CEP 88090-000
Country 4547 0
Brazil
Phone 4547 0
55 (48) 33218650
Fax 4547 0
Email 4547 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
No additional documents have been identified.