Sleep Ergonomics in Low Back Pain

NCT ID: NCT03342885

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-03

Study Completion Date

2019-12-31

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.

Detailed Description

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Conditions

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Low Back Pain

Keywords

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Low Back Pain Sleep ergonomics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Participants enrolled into the intervention group receive specific sleep ergonomics guidance

Group Type EXPERIMENTAL

Specific sleep ergonomics guidance

Intervention Type 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.

Control group

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

Group Type ACTIVE_COMPARATOR

General sleep ergonomics guidance

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Finland Hospital District

OTHER

Sponsor Role lead

Responsible Party

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Jari Ylinen

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jari Ylinen, MD

Role: PRINCIPAL_INVESTIGATOR

Central Finland Hospital District

Locations

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Central Finland Central Hospital

Jyväskylä, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Juhani Multanen, PhD

Role: CONTACT

Phone: 35850 555 1933

Email: [email protected]

Other Identifiers

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Dnro1E/2017

Identifier Type: -

Identifier Source: org_study_id