Sleep Ergonomics in Low Back Pain

NCT03342885 | Unknown

• 1 other identifier: Dnro1E/2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Sleep ergonomics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Reported amount of sleep

  Change from baseline to 12 month follow-up

• Number of sick leave days

  Change from baseline to 12 month follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants enrolled into the intervention group receive specific sleep ergonomics guidance

Behavioral: Specific sleep ergonomics guidance

Control group

ACTIVE COMPARATOR

Participants enrolled into the control group will receive general sleep ergonomics guidance

Behavioral: General sleep ergonomics guidance

Interventions

Specific sleep ergonomics guidance BEHAVIORAL

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.

Intervention group

General sleep ergonomics guidance BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low Back Pain
• Pain during sleep or

You may not qualify if:

• Fibromyalgia
• Inflammatory rheumatic disease
• Severe depression or other psychiatric diagnosis
• Previously received specific guidance in sleep ergonomics

Sponsors & Collaborators

• Central Finland Hospital District: lead

Study Sites (1)

Central Finland Central Hospital

Jyväskylä, 40700, Finland

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jari Ylinen, MD

  Central Finland Hospital District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juhani Multanen, PhD

CONTACT

35850 555 1933; juhani.multanen@ksshp.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 17, 2017
• Study Start: October 3, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)