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Trial registered on ANZCTR


Registration number
ACTRN12610000891022
Ethics application status
Approved
Date submitted
1/09/2010
Date registered
20/10/2010
Date last updated
20/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of a stretching activity program on musculoskeletal function in workers with low back pain.
Scientific title
Controlled clinical trial to assess the effect of a stretching activity program on muscle pain and fuction in male workers with low back pain.
Secondary ID [1] 252605 0
Nil.
Universal Trial Number (UTN)
U1111-1116-6738
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain. 258018 0
Condition category
Condition code
Musculoskeletal 258188 258188 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The stretching program is usually offered by the industry three times a week, 30 minutes a day, in group, with a physioterapist orientation. This was not an obligatory program. Workers mechanics that participated of this program for 32 weeks or more were included in the case group, and those that didn't participate of this program were included in the control group.
Intervention code [1] 257063 0
Rehabilitation
Intervention code [2] 257125 0
Prevention
Intervention code [3] 257333 0
Treatment: Other
Comparator / control treatment
This group of workers do not take part in the stretching program.
Control group
Active

Outcomes
Primary outcome [1] 259121 0
Lower back pain was measured by using the visual analog scale (VAS).
Timepoint [1] 259121 0
At the baseline.
Primary outcome [2] 259122 0
Fatigue was measured using the questionnaire of perception of fatigue.
Timepoint [2] 259122 0
At the baseline.
Primary outcome [3] 259123 0
Lumbar flexibility was assessed by measuring the flexion of the torso toward the floor using a simple universal goniometer.
Timepoint [3] 259123 0
At the baseline.
Secondary outcome [1] 265438 0
Blood samples from fasting volunteers was collected through the brachial venipuncture.
Timepoint [1] 265438 0
At baseline.
Secondary outcome [2] 265439 0
Functional capacity was evaluated by the index of work ability (WAI), which iis composed of 60 questions. The answers are converted into numerical values and then weighted. The results can range from 7 (low work capacity) to 49 points (optimal capacity of the work).
Timepoint [2] 265439 0
At baseline.

Eligibility
Key inclusion criteria
Be a participant or not in the stretching program offered freely by the company (for a period greater or equal 32 weeks), ii) having at least one event of occupational low back pain (medical leave) prior to the study, iii) have obtained values equal to 5 the questionnaire Roland Morris (RM) by Nusbaum et al.
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
As exclusion criteria were defined: i) event of low back pain in a period less or equal than 32 weeks or during the study, ii) a history of direct trauma and any type of surgery in the abdomen, chest, legs and spine, iii) a history of cardiopulmonary disorders, metabolic or neurological in the 32 weeks preceding the survey, iv) a history of infectious diseases in the 32 weeks preceding the study.

Study design
Purpose of the study
Prevention
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2827 0
Brazil
State/province [1] 2827 0

Funding & Sponsors
Funding source category [1] 257565 0
Self funded/Unfunded
Name [1] 257565 0
Address [1] 257565 0
Country [1] 257565 0
Brazil
Primary sponsor type
Individual
Name
Cintia Helena Santuzzi
Address
R. Milthor de Oliveira Fernandes, n. 50, Jardim Camburi, Vitoria - ES. CEP:29090-760
Country
Brazil
Secondary sponsor category [1] 256790 0
None
Name [1] 256790 0
Address [1] 256790 0
Country [1] 256790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259591 0
Ethics Committee of the Federal University of Espirito Santo
/ UFES
Ethics committee address [1] 259591 0
Av. Marechal Campos, 1468, Campos de Maruipe, predio da administracao, Vitoria - ES.
CEP: 29040090
Ethics committee country [1] 259591 0
Brazil
Date submitted for ethics approval [1] 259591 0
15/07/2006
Approval date [1] 259591 0
06/10/2006
Ethics approval number [1] 259591 0
(parecer n. 09/2006)

Summary
Brief summary
Technological advances and new market demands have subjected workers at a fast pace, with great physical strain, contributing to the increase in musculoskeletal injuries such as back pain.
Recent studies that concern the health of the worker seek ways to diagnose their risk factors and mechanisms that can mitigate them.
This study evaluated the effects of a stretching program for workers through an analysis of the parameters pain, perception of fatigue, lumbar flexibility, muscle damage marker creatine kinase (CK) and index of work ability (WAI).
The results showed that the group that participated in the stretching program showed a reduction of pain parameters and perception of fatigue, increased lumbar flexibility, and decrease of CK increase of WAI, suggesting that a stretching program provides an improvement of musculoskeletal conditions and may act by reducing the risk of occupational diseases. It is suggested further studies to confirm our findings.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 31553 0
Address 31553 0
Country 31553 0
Phone 31553 0
Fax 31553 0
Email 31553 0
Contact person for public queries
Name 14800 0
Cintia Helena Santuzzi
Address 14800 0
R. Milthor de Oliveira Fernandes, n. 50, apt. 404-A, Jardim Camburi - Vitoria, ES. CEP: 29090-760
Country 14800 0
Brazil
Phone 14800 0
55 (27) 9944 1177
Fax 14800 0
Email 14800 0
csantuzzi@terra.com.br
Contact person for scientific queries
Name 5728 0
Fernanda Mayrink Goncalves Zerbini
Address 5728 0
Rua Doutor Moacir Goncalves, n 255, apt 302, Jardim da Penha, Vitoria, Espirito Santo. CEP: 29060-445
Country 5728 0
Brazil
Phone 5728 0
55 (27) 8135 8610
Fax 5728 0
Email 5728 0
nandamayrink@yahoo.com.br

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