Sleep Ergonomics in Low Back Pain

Not Applicable

• Conditions: Low Back Pain
• Interventions: Behavioral: Specific sleep ergonomics guidance; Behavioral: General sleep ergonomics guidance

• Registration Number: NCT03342885
• Lead Sponsor: Central Finland Hospital District

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-03
• Study First Submitted: 2017-10-30
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-10
• Last Update Submitted: 2017-11-10
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Specific sleep ergonomics guidance	Participants enrolled into the intervention group receive specific sleep ergonomics guidance
Control group	General sleep ergonomics guidance	Participants enrolled into the control group will receive general sleep ergonomics guidance

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI) score	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.
Pain Visual Analog Scale (VAS)	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).

Secondary Outcome Measures

Name	Time	Method
Number of sick leave days	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.
Reported amount of sleep	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.

Trial Locations

Locations (1)

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland