Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000929404 |
Date of registration:
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12/07/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effects of sleeping postures on back pain, quality of life and sleep quality
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Scientific title:
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Effects of sleeping postures on back pain, quality of life and sleep quality in young adults |
Date of first enrolment:
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13/01/2013 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616000929404.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Prof Gustavo Desouzart
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Address:
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Polytechnic Institute of Leiria-Campus 2-Morro do Lena-Alto do Vieiro-Apartado 4137 2411-901 Leiria - Portugal
Portugal |
Telephone:
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+351911973370 |
Email:
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gustavodesouzart@gmail.com |
Affiliation:
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Name:
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Prof Gustavo Desouzart
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Address:
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Polytechnic Institute of Leiria-Campus 2-Morro do Lena-Alto do Vieiro-Apartado 4137 2411-901 Leiria - Portugal
Portugal |
Telephone:
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+351911973370 |
Email:
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gustavodesouzart@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: - Clinical diagnosis nonspecific chronic back pain
- Young adults aged between 18 and 25 years old
- Lived in collective residences (such as the case of university students and the Air Force Military)
Exclusion criteria: - Presenting a limiting clinical diagnosis (e.g. Spinal disc herniation)
- Undergoing rehabilitation
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Non specific chronic back pain;Sleep disorders; Non specific chronic back pain Sleep disorders
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Physical Medicine / Rehabilitation - Physiotherapy
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Musculoskeletal - Other muscular and skeletal disorders
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Intervention(s)
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To check the hypothesis related to differences in back pain, quality of life indices and sleep quality indices, three groups were created after an initial analysis of postural behaviors during sleep period. All participants (males and females, students and military) were separated into 3 groups, conveniently chosen according to the self-related level of back pain and quality of life indices to homogenize the sample. So, each group was linear at baseline with four male and four female in each group: i) Experimental Group (EG); ii) Placebo Group (PG) and; iii) Control Group (CG). i) Experimental Group (EG) Based on Gracovetsky (1987), Haex (2005) and Tetley (2000), individuals in the Experimental Group (EG) were instructed according to the method used in this study, which represents the recommendations of the ideal sleeping posture with the optimal quantity and place of use of pillows (using a pillow in mixed position) considering the pathological problems or the amount of back pain reported (Intervention program). Firstly, the principal investigator gave to the participants initial instructions in a lecture for a small group with 30 minutes of duration. Second, weekly positive reinforcement with 15 minutes of duration plus sending the presented material and informal contact through e-mail and phone, as preferred by the participant, were given. Thus, participants in EG (Group I – Experimental), altered the initial body posture while sleeping to: a) Lateral decubitus right or left, for participants with neck and dorsal pain, the use of a pillow under the lateral head / neck with height of the distance between the shoulder and the neck of each participant, a pillow between the knees and a pillow between the arms or; b) Supine, for participants with low back
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Primary Outcome(s)
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Observations of sleeping posture behaviour in 24 young adults assessed over three nights using video analysis and iSEE software.[Three consecutive nights at baseline and 3 months after recommendations of sleeping positions are given]
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Secondary Outcome(s)
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Analysis of intervention ergonomic program in sleep period with questionnaire about severity of back pain, assessed by visual analogue scale (VAS).[Weekly throughout the 3 month study period by personal contact or by phone or email contact.]
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Analysis of intervention ergonomic program in sleep period with questionnaire about severity of Sleep quality, assessed by Pittsburg Sleep Quality Index (PSQI).[Weekly throughout the 3 month study period by personal contact or by phone or email contact.]
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Analyze adherence to postural recommendations, assessed over three nights using video and iSEE software.[three consecutive nights 3 months after recommendations of sleeping positions are given.]
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Analysis of intervention ergonomic program in sleep period with questionnaire about severity of Quality of life, assessed by WHOQOL-Bref.[Weekly throughout the 3 month study period by personal contact or by phone or email contact.]
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Source(s) of Monetary Support
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Self funded/Unfunded
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Council of the Faculty of Human Kinetics, University of Lisbon
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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