Sleep Ergonomics in Low Back Pain

Low Back Pain Clinical Trial

— SLEEPLBP  

Official title:

The Effect of Sleep Ergonomics on Pain Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03342885
• Other study ID #: Dnro1E/2017
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2017
• Last updated: November 10, 2017
• Start date: October 3, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: Central Finland Hospital District
• Contact: Juhani Multanen, PhD
• Phone: 35850 555 1933
• Email: juhani.multanen[@]ksshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä

Sponsors (1)

Lead Sponsor	Collaborator
Central Finland Hospital District

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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