Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000929404
Ethics application status
Approved
Date submitted
11/01/2016
Date registered
12/07/2016
Date last updated
12/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of sleeping postures on back pain, quality of life and sleep quality
Scientific title
Effects of sleeping postures on back pain, quality of life and sleep quality in young adults
Secondary ID [1] 288268 0
None
Universal Trial Number (UTN)
U1111-1178-2799
Trial acronym
EofSPonBPQOLSQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non specific chronic back pain 297212 0
Sleep disorders 297215 0
Condition category
Condition code
Musculoskeletal 297421 297421 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297422 297422 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 pain, with the use of a low pillow (5 cm) below the head / neck and a pillow or high roller (15cm height) below the knees.
These positions have been indicated depending the pain area in order to keep a good balance and alignment of the spine and distribute the body's weight over the entire surface of the mattress (Haex, 2005; Desouzart, Matos, Melo, & Filgueiras, 2016; Verhaert, et al., 2012; Gracovetsky, 1987).
These indications will be held every day for the duration of this study (3 month), which provided a continuous reinforcement of the method through informal contact via email and mobile phone for any questions and issues.
ii) Placebo Group (PG)
To prove the reliability of the method, an intervention was performed with a second experimental group (Placebo Group – PG) that received and perform the technique of progressive muscle relaxation Jacobson (Jacobson, 1938; Toledo & Bara Filho, 2007). Later designated Group II - Placebo. Jacobson's relaxation technique, also known as progressive relaxation therapy, is a type of therapy that focuses on tightening and relaxing specific muscle groups in sequence. Again, the principal investigator conducted an initial lectures during 30 minutes with a small group, and weekly positive reinforcement for 15 minutes (with sending the material presented and informal contact through e-mail and phone, as preferred by the participant)
Progressive relaxation is a technique of fourteen groups of exercises in which 16 muscle groups (Head and face, anterior trunk, posterior, superior and inferior, upper and lower limbs) they are relaxed one after another. Each group is first placed in tension and then relaxed several times, achieving a relaxation ever-deeper muscle group. The following stress-relaxation of every muscle group is repeated to achieve relaxation in the muscles in question, equal to the relaxation in parts already relaxed, at least three repetitions in each group.
These details were also held every day for the duration of the study for approximately 15 minutes per day immediately before bed throughout the intervention period. This relaxation technique was considered Placebo because the participants were informed that this intervention was shown for the relief of back pain. However, little or nothing is referenced in the literature on the effectiveness of the technique of progressive muscle relaxation approach recommendations for aspects such as back pain or improve quality of life (Toledo & Bara Filho, 2007; Laloni, 1997; Davis, Eshelman, & Mackay, 1996; Junqueira & Ribeiro, 2006).
At the end of the 3rd month, all subjects (EG, PG) were re-filmed during 3 consecutive nights to analyze whether recommended changes were implemented. Participants were also asked to fulfill a questionnaire about the level of pain, quality of life and quality of sleep as well as a functional daily to see if there was any change in behavior or in the environment.
Intervention code [1] 293559 0
Lifestyle
Intervention code [2] 293560 0
Behaviour
Comparator / control treatment
With the third group (Control group-CG, subsequently appointed Group III - Control) we made an interview with the indication to the participants to maintain the usual sleeping posture that they already use. They were also informed that they would have to fulfill other questionnaires in the future with questions about their sleeping posture. All participants in CG were interviewed and received the indication to maintain the same habitual posture as well as information about future questionnaires. At the end of the 3rd month, all subjects were re-filmed during 3 consecutive nights and were asked to answer the questionnaire about daily and night activity to analyze if these group maintaining the same habitual sleep positions.
Control group
Active

Outcomes
Primary outcome [1] 296983 0
Observations of sleeping posture behaviour in 24 young adults assessed over three nights using video analysis and iSEE software.
Timepoint [1] 296983 0
Three consecutive nights at baseline and 3 months after recommendations of sleeping positions are given
Secondary outcome [1] 319801 0
Analysis of intervention ergonomic program in sleep period with questionnaire about severity of back pain, assessed by visual analogue scale (VAS).
Timepoint [1] 319801 0
Weekly throughout the 3 month study period by personal contact or by phone or email contact.
Secondary outcome [2] 321605 0
Analysis of intervention ergonomic program in sleep period with questionnaire about severity of Sleep quality, assessed by Pittsburg Sleep Quality Index (PSQI).
Timepoint [2] 321605 0
Weekly throughout the 3 month study period by personal contact or by phone or email contact.
Secondary outcome [3] 322503 0
Analysis of intervention ergonomic program in sleep period with questionnaire about severity of Quality of life, assessed by WHOQOL-Bref.
Timepoint [3] 322503 0
Weekly throughout the 3 month study period by personal contact or by phone or email contact.
Secondary outcome [4] 322504 0
Analyze adherence to postural recommendations, assessed over three nights using video and iSEE software.
Timepoint [4] 322504 0
three consecutive nights 3 months after recommendations of sleeping positions are given.

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presenting a limiting clinical diagnosis (e.g. Spinal disc herniation)
- Undergoing rehabilitation

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled 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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation by SPSS) stratified by the average of pain reported by the participants
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Cohort: group of individuals, initially defined and composed, with common characteristics (e.g., condition, birth year), who are examined or traced over a given time period
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Qualitative research produces large amounts of textual data in the form of transcripts. High quality analysis of qualitative research can produce vast amounts of data (Pope, Ziebland, & Mays, 2000). According Sterne, Egger, & Smith (2001), the smaller a study the larger the treatment effect necessary for the results to be significant.
Considering the university context, the research started with 89 students (23 male and 66 female) of healthcare domain (physiotherapy, occupational therapy, speech therapy, nursing, dietary therapy and, sport and wellness), aged between 17 and 30 years, from the Polytechnic Institute of Leiria of Portugal. Of these, all students (n=89) residing in dormitories answered a questionnaire about the perception of quality of life according to the abbreviated questionnaire on quality of life (WHOQOL-Bref), studying in the healthcare domain, but only 12 female (mean=19.75 years old +1.138) have volunteered to participate in this study.
Regarding to military context, 134 soldiers (112 male and 22 female), aged between 18 and 25 years, from to the air base n.5 of the Portuguese air force were selected to participate in the study. These, 66 soldiers answered a questionnaire about the perception of quality of life according to the abbreviated questionnaire on quality of life (WHOQOL-Bref), and only 12 male (mean=22.17 years old +1.749) have volunteered to participate in this study.
For the present study, due to the low number of participants (n= 24) according to the statement several authors (Sterne, Egger, & Smith, 2001; Pope, Ziebland, & Mays, 2000; Patton, 2005), no formal power calculation was performed because only this number of participants were volunteer to complete all procedures, the researchers chose to conduct a qualitative analysis, in order to make the most effective results and capable of being reproduced in other populations with the same characteristics.
For the carrying out of this study, the Visual Analogue Scale (VAS) was used to measure of back pain, the Pittsburgh Sleep Quality Index (PSQI) was used to measure the Sleep quality and the abbreviated questionnaire on quality of life (WHOQOL-Bref), was used to measure the intensity on the quality of life (Canavarro, et al., 2009) before (1st phase) and after (2nd phase) three consecutive month an Intervention ergonomics program.
All data were coded and computerized with statistical analysis performed using Statistical Package for the Social Sciences (SPSS), version 20.0. Baseline differences between the EG, PG and CG in primary and secondary outcome measures were assessed by the test of parametric statistics One-Way ANOVA (analysis of variance the different group at different times), setting the level of significance at p = .05. Training effects in these measures were determined by using an ANOVA to analyze differences between pretraining and posttraining score. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/01/2013
Date of last participant enrolment
Anticipated
Actual
29/03/2013
Date of last data collection
Anticipated
Actual
14/02/2014
Sample size
Target
36
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 7503 0
Portugal
State/province [1] 7503 0
Leiria

Funding & Sponsors
Funding source category [1] 293071 0
Self funded/Unfunded
Name [1] 293071 0
Self funded/Unfunded
Country [1] 293071 0
Primary sponsor type
University
Name
Motor Behavior Laboratory of the Faculty of Human Kinetics - University of Lisbon
Address
Estr. da Costa, 1499-002 Lisbon
Country
Portugal
Secondary sponsor category [1] 292074 0
None
Name [1] 292074 0
None
Address [1] 292074 0
None
Country [1] 292074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294125 0
Ethics Council of the Faculty of Human Kinetics, University of Lisbon
Ethics committee address [1] 294125 0
Ethics committee country [1] 294125 0
Portugal
Date submitted for ethics approval [1] 294125 0
31/05/2011
Approval date [1] 294125 0
04/07/2012
Ethics approval number [1] 294125 0
Scientific Committee of the Faculty of Human Kinetics and The ethics committee of the Faculty of Human Kinetics, University of Lisbon approved the experimental procedures with No. 13/2014.

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

Contacts
Principal investigator
Name 62574 0
Prof Gustavo Desouzart
Address 62574 0
Polytechnic Institute of Leiria-Campus 2-Morro do Lena-Alto do Vieiro-Apartado 4137 2411-901 Leiria - Portugal
Country 62574 0
Portugal
Phone 62574 0
+351911973370
Fax 62574 0
Email 62574 0
[email protected]
Contact person for public queries
Name 62575 0
Gustavo Desouzart
Address 62575 0
Polytechnic Institute of Leiria-Campus 2-Morro do Lena-Alto do Vieiro-Apartado 4137 2411-901 Leiria - Portugal
Country 62575 0
Portugal
Phone 62575 0
+351911973370
Fax 62575 0
Email 62575 0
[email protected]
Contact person for scientific queries
Name 62576 0
Gustavo Desouzart
Address 62576 0
Polytechnic Institute of Leiria-Campus 2-Morro do Lena-Alto do Vieiro-Apartado 4137 2411-901 Leiria - Portugal
Country 62576 0
Portugal
Phone 62576 0
+351911973370
Fax 62576 0
Email 62576 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 Desouzart, G., Filgueiras, E., & Matos, R. (2015).... [More Details]
Study results articleYes Desouzart, G., & Filgueiras, E. (2015, August). Hu... [More Details]
ThesisNo Almeida, G. C. D. D. (2015). Efeitos de uma interv... [More Details]

Documents added automatically
No additional documents have been identified.