Sleep Ergonomics in Low Back Pain (SLEEPLBP)
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Specific sleep ergonomics guidance
General sleep ergonomics guidance
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Sleep ergonomics
Eligibility Criteria
Inclusion Criteria:
- Low Back Pain
- Pain during sleep or
Exclusion Criteria:
- Fibromyalgia
- Inflammatory rheumatic disease
- Severe depression or other psychiatric diagnosis
- Previously received specific guidance in sleep ergonomics
Sites / Locations
- Central Finland Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Participants enrolled into the intervention group receive specific sleep ergonomics guidance
Participants enrolled into the control group will receive general sleep ergonomics guidance
Outcomes
Primary Outcome Measures
Pain Visual Analog Scale (VAS)
Low back pain reported with Visual Analog Scale (VAS) during rest, after getting up and during day; 0-100 mm scales, 0 mm = no pain, 100 mm = worst possible pain. Change from baseline to 12 month follow-up is reported in mm for each sub-scale (during rest, after getting up and during day).
Oswestry Disability Index (ODI) score
Oswestry Disability Index Finnish version 2.0 total score (scale 0-100%): 0 = minimal disability, 100 = bed-bound or exaggeration of symptoms; and sub-scores (scale 0-5): 0 = minimal disability, 5 = worst disability. Change is reported for total ODI score and sub-scores from baseline to 12 month follow-up.
Secondary Outcome Measures
Reported amount of sleep
Perceived sufficiency of sleep based on question: "Do you feel that you have got sufficient sleep during last week?", reported with 5 step Likert scale (scale 1-5), 1 = not sufficient at all, 5 = totally sufficient. Change in perceived sufficiency of sleep is reported from baseline to 12 month follow-up.
Number of sick leave days
Number of sick leave days during last 12 months as reported by the participant. Change in sick leave days during last 12 months is reported from baseline to 12 month follow-up.
Full Information
NCT ID
NCT03342885
First Posted
October 30, 2017
Last Updated
November 10, 2017
Sponsor
Central Finland Hospital District
1. Study Identification
Unique Protocol Identification Number
NCT03342885
Brief Title
Sleep Ergonomics in Low Back Pain
Acronym
SLEEPLBP
Official Title
The Effect of Sleep Ergonomics on Pain Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Finland Hospital District
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the effect of sleep ergonomics guidance given by physiotherapist on pain and disability in patients with low back pain. In this randomized controlled trial participants are assigned either into the intervention or the control group. The intervention group will receive detailed instruction on sleeping ergonomics whereas the control group will only be instructed to avoid painful sleeping posture. The initial hypothesis is that in the intervention group pain and disability will decrease more compared to the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Sleep ergonomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants enrolled into the intervention group receive specific sleep ergonomics guidance
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants enrolled into the control group will receive general sleep ergonomics guidance
Intervention Type
Behavioral
Intervention Name(s)
Specific sleep ergonomics guidance
Intervention Description
Participants receive a detailed instruction in sleep ergonomics. Participants are instructed to maintain either side lying or supine sleeping posture, depending on which is less painful. Neutral position of spine supported by specific placement of body pillow. Changing of posture during sleep is prevented. The participants are recommended to replace their mattress if they feel that it is too hard or too soft. Instruction is given by a physiotherapist during one personal therapy session and the participants also receive a printed instruction.
Intervention Type
Behavioral
Intervention Name(s)
General sleep ergonomics guidance
Intervention Description
Participants are instructed find most comfortable sleeping posture by personal preference and to avoid painful posture. The participants are recommended to replace their mattress if they feel that it is too hard or too soft. Instruction is given by a physiotherapist during one personal therapy session and the participants also receive a printed instruction.
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale (VAS)
Description
Low back pain reported with Visual Analog Scale (VAS) during rest, after getting up and during day; 0-100 mm scales, 0 mm = no pain, 100 mm = worst possible pain. Change from baseline to 12 month follow-up is reported in mm for each sub-scale (during rest, after getting up and during day).
Time Frame
Change from baseline to 12 month follow-up
Title
Oswestry Disability Index (ODI) score
Description
Oswestry Disability Index Finnish version 2.0 total score (scale 0-100%): 0 = minimal disability, 100 = bed-bound or exaggeration of symptoms; and sub-scores (scale 0-5): 0 = minimal disability, 5 = worst disability. Change is reported for total ODI score and sub-scores from baseline to 12 month follow-up.
Time Frame
Change from baseline to 12 month follow-up
Secondary Outcome Measure Information:
Title
Reported amount of sleep
Description
Perceived sufficiency of sleep based on question: "Do you feel that you have got sufficient sleep during last week?", reported with 5 step Likert scale (scale 1-5), 1 = not sufficient at all, 5 = totally sufficient. Change in perceived sufficiency of sleep is reported from baseline to 12 month follow-up.
Time Frame
Change from baseline to 12 month follow-up
Title
Number of sick leave days
Description
Number of sick leave days during last 12 months as reported by the participant. Change in sick leave days during last 12 months is reported from baseline to 12 month follow-up.
Time Frame
Change from baseline to 12 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low Back Pain
Pain during sleep or
Exclusion Criteria:
Fibromyalgia
Inflammatory rheumatic disease
Severe depression or other psychiatric diagnosis
Previously received specific guidance in sleep ergonomics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juhani Multanen, PhD
Phone
35850 555 1933
Email
juhani.multanen@ksshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jari Ylinen, MD
Organizational Affiliation
Central Finland Hospital District
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Central Hospital
City
Jyväskylä
ZIP/Postal Code
40700
Country
Finland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Sleep Ergonomics in Low Back Pain
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