Sleep Ergonomics in Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Sleep Ergonomics on Pain Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Specific sleep ergonomics guidance
* Behavioral: General sleep ergonomics guidance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants enrolled into the intervention group receive specific sleep ergonomics guidance | Behavioral: Specific sleep ergonomics guidance<br>* 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.<br>|
| Active Comparator: Control group<br>Participants enrolled into the control group will receive general sleep ergonomics guidance | Behavioral: General sleep ergonomics guidance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from baseline to 12 month follow-up | 
| 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. | Change from baseline to 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change 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. | Change from baseline to 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Sleep ergonomics