Sleep Ergonomics in Low Back Pain (SLEEPLBP)
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|ClinicalTrials.gov Identifier: NCT03342885|
Recruitment Status : Unknown
Verified November 2017 by Jari Ylinen, Central Finland Hospital District.
Recruitment status was: Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Behavioral: Specific sleep ergonomics guidance Behavioral: General sleep ergonomics guidance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Effect of Sleep Ergonomics on Pain Low Back Pain|
|Actual Study Start Date :||October 3, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Intervention group
Participants enrolled into the intervention group receive specific sleep ergonomics guidance
Behavioral: Specific sleep ergonomics guidance
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.
Active Comparator: Control group
Participants enrolled into the control group will receive general sleep ergonomics guidance
Behavioral: General sleep ergonomics guidance
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.
- Pain Visual Analog Scale (VAS) [ Time Frame: Change from baseline to 12 month follow-up ]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 [ Time Frame: Change from baseline to 12 month follow-up ]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.
- Reported amount of sleep [ Time Frame: Change from baseline to 12 month follow-up ]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 [ Time Frame: Change from baseline to 12 month follow-up ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Low Back Pain
- Pain during sleep or
- Inflammatory rheumatic disease
- Severe depression or other psychiatric diagnosis
- Previously received specific guidance in sleep ergonomics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342885
|Contact: Juhani Multanen, PhD||35850 555 email@example.com|
|Central Finland Central Hospital||Recruiting|
|Jyväskylä, Finland, 40700|
|Principal Investigator:||Jari Ylinen, MD||Central Finland Hospital District|
|Responsible Party:||Jari Ylinen, Chief Physician, Central Finland Hospital District|
|Other Study ID Numbers:||
|First Posted:||November 17, 2017 Key Record Dates|
|Last Update Posted:||November 17, 2017|
|Last Verified:||November 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Low Back Pain
Low Back Pain