Sleep Ergonomics in Low Back Pain (SLEEPLBP)

• ClinicalTrials.gov Identifier: NCT03342885
• Recruitment Status: Unknown
• First Posted: November 17, 2017
• Last Update Posted: November 17, 2017
• Sponsor: Central Finland Hospital District
• Information provided by (Responsible Party): Jari Ylinen, Central Finland Hospital District

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Specific sleep ergonomics guidance; Behavioral: General sleep ergonomics guidance	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Juhani Multanen, PhD; 35850 555 1933; juhani.multanen@ksshp.fi

Locations

Finland

Central Finland Central Hospital; Recruiting

Jyväskylä, Finland, 40700

Sponsors and Collaborators

Central Finland Hospital District

Investigators

• Principal Investigator: Jari Ylinen, MD; Central Finland Hospital District

More Information

• Responsible Party: Jari Ylinen, Chief Physician, Central Finland Hospital District
• ClinicalTrials.gov Identifier: NCT03342885
• Other Study ID Numbers: Dnro1E/2017
• First Posted: November 17, 2017
• 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

Keywords provided by Jari Ylinen, Central Finland Hospital District:

Low Back Pain; Sleep ergonomics

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations