Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001365459
Ethics application status
Approved
Date submitted
30/06/2016
Date registered
30/09/2016
Date last updated
30/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Postural education in the musculoskeletal pain in children of basic education
Scientific title
Postural education: the relationship between Postural habits and musculoskeletal pain in children of basic education
Secondary ID [1] 288716 0
None
Universal Trial Number (UTN)
U1111-1180-5145
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal pain 297952 0
postural changes 297953 0
Condition category
Condition code
Musculoskeletal 298113 298113 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Considered the best way in order to maintain a healthy body and pain-free, maintaining perfect posture, along with regular physical activity, increase awareness to design an educational program of preventive approach, designed to be implemented in the environment school. This program, as well as the back-school, developed and implemented by Zachrisson (1981), aims to reduce the number of musculoskeletal complaints, especially in the spine area, presented by school children. It is believed that postural educational habits also play an essential role in the health of children, the Back-school program is responsible for bringing postural education for the school context, with different preventive strategies for children to apply in their daily lives.
This back-school education program recommends the following postural habits - Seated; standing; lying; backpack and transportation; Weight of transport:
- Sitting: Maintenance of standing back against the back of the chair; positioning the region of the closest possible glutes of the chair and your feet flat on the floor. Where the chair did not allow proper support of the feet on the ground, the students were asked to put a support (books, shoe box);
- Standing with the upright head; back straight and feet apart at shoulder width;
- Lying in lateral decubitus cushion in the head with a height equal to distance between the shoulder and neck and pillow between your legs;
- Carry a backpack with a strap on each shoulder, avoid carrying more than 10% by body weight.
- Survey and object transfer: proper way to pick up objects on the floor: perform the activity bending your knees and not the spine; correct way to transfer objects from one place to another, stand in front of the object, hold it with both hands and close to the body, avoiding twisting the trunk.
This program is carried out during physical education classes, with a frequency of 30 minutes 3 times a week for 4 weeks. The sessions with students were always carried out by the principal investigator, PhD in Human Kinetics, and the only teacher the role of observer. Before these sessions with students, the principal investigator instructed the teachers to the same rules to be passed to students, these sessions began a week before the investigation period and lasted until the end of it. These sessions were always conducted by the principal investigator and were conducted only for teachers in lectures with a frequency of 1 time 1 time per week for 5 weeks, giving indications of the positions that should guide their students during the class period.
These attitudes were reinforced with meetings held by the principal investigator, and teachers role of observing the posture of his students and guides them when they are inadequate, indicating the ideas postures provided in study sessions.
Intervention code [1] 294153 0
Lifestyle
Comparator / control treatment
Maintaning the same postural habits and aanswer the questionaire at baseline and after 1 month.
Control group
Active

Outcomes
Primary outcome [1] 297678 0
Analysis a musculoskeletal pain assessment in school age children using questionnaire according to Body Discomfort Scale (Corlett and Bishop, 1976) in order to verify and categorize the pain felt (where 0 corresponded to no pain and 5 to the full amount of pain felt by the subject), and its duration (acute pain, subacute or chronic pain).
Timepoint [1] 297678 0
At baseline and after 1 month
Primary outcome [2] 299609 0
Analysis an initial postural behavior assessment in school age children using questionnaire according to Body Discomfort Scale (Corlett and Bishop, 1976) and postural habits and changes during the school year.
Timepoint [2] 299609 0
At baseline and after 1 month
Secondary outcome [1] 321801 0
Analyse whether ergonomics postural recommended were implemented.
Timepoint [1] 321801 0
Twice a weeks during four weeks after ergonomics postural recommended, there was a personal or telephone contact with teachers and parents
Secondary outcome [2] 321802 0
Correlation between musculoskeletal pain and postural behaviour when ergonomics postural recommended was implemented using questionnaire according to Body Discomfort Scale (Corlett and Bishop, 1976).
Timepoint [2] 321802 0
One month after postural recommendations are given

Eligibility
Key inclusion criteria
- Young and teenager,
- Belonging to the2nd Basic Education Cycle (5th grade) and the 3rd Basic Education Cycle (9th grade);
- Belonging to the Basic School 2/3 D. Dinis
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria
All students that the parents consented, were analyzed

Study design
Purpose of the study
Educational / counselling / training
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For this purpose, all students in the 5th grade and 9th grade were invited to participate in this study.
In a population of 259 students (121 of 5th grade and 138 of the 9th grade) participated 204 students (78.8%) and 102 students of the 5th grade (84.3%) and 102 students in the 9th grade (73.9% ).
SPSS, 20.0 version was used in order to treat all the statistical data, for normality verification Kolmogorov-Smirnov test was applied before a descriptive analysis. This last, was calculated based upon standard methods. In order to analyze any characteristically difference between both groups, the t test was applied. In order to find variable relations Pearson’s correlate coefficient (r) was applied. The statistically level of significance was establish in p = 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/03/2014
Date of last participant enrolment
Anticipated
Actual
2/05/2014
Date of last data collection
Anticipated
Actual
13/06/2014
Sample size
Target
200
Accrual to date
Final
204
Recruitment outside Australia
Country [1] 7978 0
Portugal
State/province [1] 7978 0
Leiria

Funding & Sponsors
Funding source category [1] 293880 0
University
Name [1] 293880 0
Research Centre for Human Movement Sciences (CIMH) of the Polytechnic Institute of Leiria
Country [1] 293880 0
Portugal
Primary sponsor type
University
Name
Research Centre for Human Movement Sciences (CIMH) of the Polytechnic Institute of Leiria
Address
Polytechnic Institute of Leiria-Campus 2 - Morro do Lena – Alto do Vieiro - Apartado 4163 - 2411-901 Leiria
Country
Portugal
Secondary sponsor category [1] 292708 0
None
Name [1] 292708 0
none
Address [1] 292708 0
none
Country [1] 292708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295296 0
Research Centre for Human Movement Sciences (CIMH)
Ethics committee address [1] 295296 0
Ethics committee country [1] 295296 0
Portugal
Date submitted for ethics approval [1] 295296 0
06/01/2014
Approval date [1] 295296 0
24/02/2014
Ethics approval number [1] 295296 0
CIMH Approval Number: 3/2014

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

Contacts
Principal investigator
Name 64238 0
Prof Gustavo Coutinho Desouzart
Address 64238 0
Polythecnic Institute of Leiria - Campus 2 - Morro do Lena – Alto do Vieiro - Apartado 4163. 2411-901 Leiria – Portugal
Country 64238 0
Portugal
Phone 64238 0
+351911973370
Fax 64238 0
+351244845300
Email 64238 0
[email protected]
Contact person for public queries
Name 64239 0
Gustavo Coutinho Desouzart
Address 64239 0
Polythecnic Institute of Leiria - Campus 2 - Morro do Lena – Alto do Vieiro - Apartado 4163. 2411-901 Leiria – Portugal
Country 64239 0
Portugal
Phone 64239 0
+351244845300
Fax 64239 0
+351244845300
Email 64239 0
[email protected]
Contact person for scientific queries
Name 64240 0
Gustavo Coutinho Desouzart
Address 64240 0
Polythecnic Institute of Leiria - Campus 2 - Morro do Lena – Alto do Vieiro - Apartado 4163. 2411-901 Leiria – Portugal
Country 64240 0
Portugal
Phone 64240 0
+351911973370
Fax 64240 0
+351244845300
Email 64240 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes jan/jun 2020 - Desouzart, G., Santos, C., & Filgue... [More Details]
Study results articleYes jan/jun 2020 - Desouzart, G., Santos, C., & Filgue... [More Details]

Documents added automatically
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