ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000708651

Ethics application status

Approved

Date submitted

18/06/2014

Date registered

4/07/2014

Date last updated

31/05/2019

Date data sharing statement initially provided

31/05/2019

Date results provided

31/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of sleep posture on spinal symptoms

Scientific title

An observational study comparing the sleep posture of three groups (healthy, neck pain, lumbar pain) to determine the relationship between spinal symptoms and sleep posture measured using infrared imaging and questionnaires.

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1158-1763

Trial acronym

Linked study record

Health condition

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

Lumbar pain

Lumbar stiffness

Lumbar bothersomeness

Cervical pain

Cervical stiffness

Cervical bothersomeness

Quality of sleep

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

In this observational study participants will be asked to complete the self-report questionnaires outlined below. They will be provided with an email link to access Survey Monkey questionnaires for online completion. If unable to access online, printed copies will be provided for manual completion.

Self Report Questionnaire;
1. Self-report percentage allocation sleep postures
2. General Questions; Age, Gender, Sleeping Arrangement: Partner/Solo, Height and Weight (BMI), Highest Education Level (High school, Registered Trade, Undergraduate, Post Graduate), Medications and Comorbidities.
3. 11 point numerical rating scales for bothersomeness, pain, stiffness and quality of sleep.

Medical Outcomes Study 36-Item Short-Form Health Survey
Spine Functional Index (SFI-10)
Neck Disability Index
Rowland Morris Disability Questionnaire
Hospital Anxiety and Depression Scale
Insomnia Severity Index
Pittsburgh Sleep Quality Index

Infrared cameras will be temporarily installed on stands, in the participant's bedroom and activated automatically to record from 8PM to 8AM. Recording will occur for 3 consecutive nights.
The cameras will record posture and later during analysis, time spent in each primary (prone, supine) and intermediate (supported sidelying and 3/4 prone) posture will be calculated. In addition, the number of posture shifts per night and the number of long periods of immobility (no posture shift for 30 minutes) will be calculated.

Intervention code [1]

Not applicable

Comparator / control treatment

Comparisons will be made between healthy group and pain groups (cervical and lumbar)

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Video analysis determining time spend in each primary and intermediate sleep posture

Timepoint [1]

Baseline

Primary outcome [2]

Numerical Rating Scale - Bothersomeness

Timepoint [2]

Baseline

Primary outcome [3]

Numerical Rating Scale - Pain

Timepoint [3]

Baseline

Secondary outcome [1]

Medical Outcomes Study 36-Item Short-Form Health Survey

Timepoint [1]

Baseline

Secondary outcome [2]

Spine Functional Index (SFI-10)

Timepoint [2]

Baseline

Secondary outcome [3]

Neck Disability Index

Timepoint [3]

Baseline

Secondary outcome [4]

Rowland Morris Disability Questionnaire

Timepoint [4]

Baseline

Secondary outcome [5]

Hospital Anxiety and Depression Scale

Timepoint [5]

Baseline

Secondary outcome [6]

Insomnia Severity Index

Timepoint [6]

Baseline

Secondary outcome [7]

Pittsburgh Sleep Quality Index

Timepoint [7]

Baseline

Secondary outcome [8]

Numerical Rating Scale - Stiffness

Timepoint [8]

Baseline

Secondary outcome [9]

Numerical Rating Scale - Quality of Sleep

Timepoint [9]

Baseline

Eligibility

Key inclusion criteria

Three groups will be recruited for this study. All persons will be required to be fluent and literate in English.

One group will be healthy volunteers with no spinal symptoms.

The second group will include volunteers who experience predominantly cervical 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.

The third group will include volunteers who experience predominantly lumbar 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?

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, coexisting 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

Duration

Selection

Timing

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

17/05/2017

Date of last data collection

Anticipated

Actual

15/11/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent Street, Bentley WA 6012

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Kent Street, Bentley WA 6012

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Kent Street, Bentley WA 6012

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/06/2014

Approval date [1]

15/07/2014

Ethics approval number [1]

Summary

Brief summary

Some sleep postures place rotation and extension loads on spinal tissues. If maintained for prolonged periods of time, they could potentially cause pain and stiffness.
The hypothesis of this study is that prone and 3/4 prone postures will increase spine symptoms and that people sleeping in these positions will have more frequent symptoms and a poorer quality of sleep.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Doug Cary

Address

School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845

Country

Australia

Phone

+618 90715055

Fax

[email protected]

Contact person for public queries

Name

Doug Cary

Address

School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845

Country

Australia

Phone

+618 90715055

Fax

[email protected]

Contact person for scientific queries

Name

Doug Cary

Address

School of Physiotherapy and Exercise Science
Curtin University, GPO Box U1987, Kent Street, Bentley WA 6845

Country

Australia

Phone

+618 90715055

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Information will be presented in peer reviewed documents

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Cary D, Collinson R, Sterling M, Briffa NK. 2016. ... [More Details]
Study results article	Yes	Cary D, Collinson R, Sterling M, Briffa NK. 2019. ... [More Details]
Study results article	Yes	Cary D, Briffa K, McKenna L. 2019. Identifying rel... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Examining relationships between sleep posture, waking spinal symptoms and quality of sleep: A cross sectional study.	2021	https://dx.doi.org/10.1371/journal.pone.0260582

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically