Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000707662
Ethics application status
Approved
Date submitted
18/06/2014
Date registered
4/07/2014
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Date results provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of changing sleep posture on spinal symptoms
Scientific title
An uncontrolled intervention study examining the ability of the participants' (aged 18-45 years) who have morning symptoms of neck or back pain, to change their sleep posture and the effects of changing sleep posture on their spinal symptoms and quality of sleep.
Secondary ID [1] 284798 0
nil
Universal Trial Number (UTN)
U1111-1158-0151
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar pain





 292174 0
Lumbar stiffness 292287 0
Lumbar bothersomeness 292288 0
Cervical pain 292289 0
Cervical stiffness 292290 0
Cervical bothersomeness 292291 0
Quality of sleep 292292 0
Condition category
Condition code
Musculoskeletal 292511 292511 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study will be the instruction and explanation of the benefits of particular sleeping postures.
This will involve;
1. Explaining the rationale for why some sleep postures may aggravate spinal pain and stiffness and hence why modification may reduce symptoms
2. Investigator placing participant in the prone and 3/4 prone postures and emphasizing the extension and rotational stress being placed on the lumbar and cervical spine
3. The investigator then placing participants in supine and support side lying to demonstrate preferred postures for the lumbar and cervical spine
4. Providing an A4 printout summarizing the preferred postures and benefits with pictures and text details.

Approximate instructional period will be 30 minutes and provided on an individual basis in the person’s home at same time as previously installed cameras are removed.

Participants will be asked to not change medications, or bedding or commence spinal treatment over the intervention period of one month.

Participants will be provided with an email link to Survey Monkey questionnaires to be completed online. If unable to access online, printed copies will be provided for manual completion.

2 infrared cameras will be temporarily installed on stands in the bedroom and activated automatically to record from 8PM to 8AM. Recording will occur for 3 consecutive nights.
Intervention code [1] 289588 0
Treatment: Other
Comparator / control treatment
Single arm longitudinal study comparing pre-intervention symptoms with post-intervention symptoms.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292367 0
Video analysis determining time spent in each primary and intermediate sleep posture
Timepoint [1] 292367 0
Baseline
1 month after intervention
Primary outcome [2] 292473 0
Numerical Rating Scale: Bothersomeness
Timepoint [2] 292473 0
Baseline
1 month after intervention
3 months after intervention
Primary outcome [3] 292474 0
Numerical Rating Scale: Pain
Timepoint [3] 292474 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [1] 308789 0
Medical Outcomes Study 36-Item Short-Form Health Survey
Timepoint [1] 308789 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [2] 309039 0
Spine Functional Index (SFI-10)
Timepoint [2] 309039 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [3] 309040 0
Neck Disability Index
Timepoint [3] 309040 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [4] 309041 0
Rowland Morris Disability Questionnaire
Timepoint [4] 309041 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [5] 309042 0
Hospital Anxiety and Depression Scale
Timepoint [5] 309042 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [6] 309043 0
Insomnia Severity Index
Timepoint [6] 309043 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [7] 309044 0
Pittsburgh Sleep Quality Index
Timepoint [7] 309044 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [8] 309046 0
Numerical Rating Scale: Stiffness
Timepoint [8] 309046 0
Baseline
1 month after intervention
3 months after intervention
Secondary outcome [9] 309048 0
Numerical Rating Scale: Quality of Sleep
Timepoint [9] 309048 0
Baseline
1 month after intervention
3 months after intervention

Eligibility
Key inclusion criteria
Persons fluent and literate in English who experience spinal pain or stiffness or bothersomeness, greater than or equal to 3/10 on a numerical rating scale (NRS), that is greatest lying in bed or on rising (within 30 minutes) and occurs 4 or more times per month.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years and greater than 45 years of age, medical conditions or devices that prevent person from sleeping in all postures e.g. severe OA, esophageal reflux, breathing apparatus, late stage pregnancy, co existing medically diagnosed inflammatory conditions or unremitting pain e.g. RA, AS, radicular pain, taking medically prescribed hypnotic or relaxant medications and previously treated by main researcher for spinal pain.

Study design
Purpose of the study
Treatment
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
30/07/2014
Actual
9/10/2014
Date of last participant enrolment
Anticipated
Actual
15/06/2017
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
60
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 29074 0
6450 - Esperance

Funding & Sponsors
Funding source category [1] 289411 0
University
Name [1] 289411 0
Curtin University
Country [1] 289411 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley WA 6012
Country
Australia
Secondary sponsor category [1] 288094 0
None
Name [1] 288094 0
Address [1] 288094 0
Country [1] 288094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291172 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291172 0
Ethics committee country [1] 291172 0
Australia
Date submitted for ethics approval [1] 291172 0
16/06/2014
Approval date [1] 291172 0
15/07/2014
Ethics approval number [1] 291172 0

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

Contacts
Principal investigator
Name 49190 0
Mr Doug Cary
Address 49190 0
School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845
Country 49190 0
Australia
Phone 49190 0
+618 90715055
Fax 49190 0
Email 49190 0
[email protected]
Contact person for public queries
Name 49191 0
Doug Cary
Address 49191 0
School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845
Country 49191 0
Australia
Phone 49191 0
+618 90715055
Fax 49191 0
Email 49191 0
[email protected]
Contact person for scientific queries
Name 49192 0
Doug Cary
Address 49192 0
School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845
Country 49192 0
Australia
Phone 49192 0
+618 90715055
Fax 49192 0
Email 49192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
Documents were uploaded by study researchers but have since been removed.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3971Plain language summaryNo Research question Our study aimed to firstly dete... [More Details]

Documents added automatically
No additional documents have been identified.