Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000962235
Ethics application status
Approved
Date submitted
17/08/2009
Date registered
9/11/2009
Date last updated
10/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effectiveness of Global Postural Reeducation Method (GPR) and Conventional Kinesiotherapy on the Treatment of Spine Chronic Pain: Controlled Randomized Trial.
Scientific title
The effectiveness of Global Postural Reeducation Method (GPR) and conventional kinesiotherapy on pain, quality of life and functional disability in subjects with chronic spine pain.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spine chronic pain 243524 0
chronic low back pain 243525 0
chronic neck pain 243526 0
chronic thoracic pain 243527 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239824 239824 0 0
Physiotherapy
Musculoskeletal 239825 239825 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Group 1: subjects were submitted to two sessions per week (each session during one hour) for a total of 16 individual sessions of the Global Postural Reeducation Method led by an expert physiotherapist [Global Postural Reeducation Method uses various global postures to stretch the muscle chains. These postures are sustained actively by the patient, making the muscles that are being stretched maintain excentric isometric contraction. The physiotherapist leads the therapy, not allowing compensations, making the patient correct him(her)self and requesting brief and soft isometric contractions of muscles that are in pain during the postures. It is a proprioceptive inhibition method that aims muscle relaxation and stretching, pain relief, breathing release and postural rebalance];
- Group 2: subjects were submitted to two individual sessions per week (each session during one hour) for a total of 16 sessions of Conventional Kinesiotherapy (segmental stretch exercise) [The Conventional Kinesiotherapy consists in segmentar stretching exercises of various muscles involved in body posture. These stretching exercises were performed in active and assisted-active ways. Each one was performed five times and sustained for thirty seconds in each repetition. Examples of stretched muscles: paravertebrals, ischiotibials, among others];
- Group 3: control - no treatment.
Intervention code [1] 241136 0
Rehabilitation
Comparator / control treatment
- Group 1: subjects were submitted to 16 sessions of Global Postural Reeducation Method twice a week;
- Group 2: subjects were submitted to 16 sessions of Conventional Kinesiotherapy (segmental stretch exercise) twice a week;
- Group 3: control - no treatment.

The following comparations will be performed:
- Group 1 versus Group 2;
- Group 1 versus Group 3;
- Group 2 versus Group 3.
Control group
Active

Outcomes
Primary outcome [1] 240588 0
Intensity of Pain: Visual Analogue Scale and a portuguese version of the McGill Pain Questionnaire.
Timepoint [1] 240588 0
At baseline, endpoint (right after the end of the treatment) and follow-up (two months after the end of the treatment).
Primary outcome [2] 240589 0
Quality of Life: Brazilian version of SF-36 Questionnaire (all domains).
Timepoint [2] 240589 0
At baseline, endpoint (right after the end of the treatment) and follow-up (two months after the end of the treatment).
Primary outcome [3] 240590 0
Functional Disability: Brazilian version of Roland-Morris Questionnaire.
Timepoint [3] 240590 0
At baseline, endpoint (right after the end of the treatment) and follow-up (two months after the end of the treatment).
Secondary outcome [1] 257219 0
Postural Evaluation measured by Computerized Photogrammetry made with ALCImagem Software.
Timepoint [1] 257219 0
At baseline, endpoint (right after the end of the treatment) and follow-up (two months after the end of the treatment).
Secondary outcome [2] 257220 0
Anterior Spine Flexion Measure:
- forefinger-to-floor index;
- computerized photogrammetry.
Timepoint [2] 257220 0
At baseline, endpoint (right after the end of the treatment) and follow-up (two months after the end of the treatment).
Secondary outcome [3] 262188 0
Respiratory Function Evaluation performed by: Manovacuometry, Expiratory Peak Flow and Thoracic Perimetry.
Timepoint [3] 262188 0
At baseline, endpoint (right after the end of the treatment) and follow-up (two months after the end of the treatment).

Eligibility
Key inclusion criteria
Subjects who have mechanical chronic pain in any segment of the spine (neck, thorax and/or low back) lasting at least three months.
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- bearer of fibromyalgia;
- bearer of respiratory diseases;
- bearer of rheumatic autoimmune diseases;
- bearer of uncontrolled hypothyroidism or hyperthryroidism;
- subjects already submitted to spinal surgical proceedures;
- baearers of orthopedic or traumatic injuries in other joints/regions;
- bearer of psychiatric and/or cognitive illness

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 computerized randomization, the sequential numbers were kept in opaque non-translucent closed envelopes. As the patients were evaluated, they were allocated in one of the three groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence were obtained using GraphPad Statmate 1.0 software.
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
Active, not recruiting
Date of first participant enrolment
Anticipated
5/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 1954 0
Brazil
State/province [1] 1954 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 237509 0
Self funded/Unfunded
Name [1] 237509 0
Country [1] 237509 0
Primary sponsor type
Individual
Name
Marilene Mendes dos Santos
Address
Avenida Padre Francis Cletus Cox, 1661 - Jardim Country Club
Poços de Caldas/MG
CEP: 37701-355
Country
Brazil
Secondary sponsor category [1] 236988 0
University
Name [1] 236988 0
UNIFESP - Universidade Federal de Sao Paulo (In English: "Sao Paulo Federal University")
Address [1] 236988 0
Rua Pedro de Toledo, 598
Vila Clementino - Sao Paulo - SP
CEP: 04039-001
Country [1] 236988 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243638 0
Comite de Etica da Universidade Federal de Sao Paulo (In English: "Sao Paulo Federal University Ethics Commitee"
Ethics committee address [1] 243638 0
Rua Botucatu, 572, 1 andar, conjunto 14
Sao Paulo - SP
CEP: 04023-900
Ethics committee country [1] 243638 0
Brazil
Date submitted for ethics approval [1] 243638 0
Approval date [1] 243638 0
30/03/2007
Ethics approval number [1] 243638 0
1/07/0350

Summary
Brief summary
Primary purpose of the study: to assess the effectiveness of Global Posture Reeducation Method in the treatment of chronic spine pain.

Hypothesis: The Global Posture Reeducation Method presents better results when compared to Conventional Kinesiotherapy and to no treatment of chronic spine pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30057 0
Address 30057 0
Country 30057 0
Phone 30057 0
Fax 30057 0
Email 30057 0
Contact person for public queries
Name 13304 0
Marilene Mendes dos Santos
Address 13304 0
Avenida Padre Francis Cletus Cox, 1661 - Jardim Country Club
Pocos de Caldas/MG
CEP: 37701-355
Country 13304 0
Brazil
Phone 13304 0
+55 35 3729 9252
Fax 13304 0
+55 35 3729 9201
Email 13304 0
[email protected] / [email protected]
Contact person for scientific queries
Name 4232 0
Marilene Mendes dos Santos
Address 4232 0
Avenida Padre Francis Cletus Cox, 1661 - Jardim Country Club
Pocos de Caldas/MG
CEP: 37701-355
Country 4232 0
Brazil
Phone 4232 0
+55 35 3729 9252
Fax 4232 0
+55 35 3729 9201
Email 4232 0
[email protected] / [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

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