Low Back PainSLEEPLBPNCT03342885
Sleep Ergonomics in Low Back Pain
A study testing Specific sleep ergonomics guidance and General sleep ergonomics guidance in people with Low Back Pain, run by Central Finland Hospital District at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Specific sleep ergonomics guidance and General sleep ergonomics guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 3 Oct 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low Back Pain
- Pain during sleep or
Who cannot join
- Fibromyalgia
- Inflammatory rheumatic disease
- Severe depression or other psychiatric diagnosis
- Previously received specific guidance in sleep ergonomics
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Central Finland Central Hospital
Jyväskylä, 40700
About this study
Official title: The Effect of Sleep Ergonomics on Pain Low Back Pain
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
- Being tested
- Specific sleep ergonomics guidance, General sleep ergonomics guidance
- Keywords
- Low Back Pain, Sleep ergonomics
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific sleep ergonomics guidanceBehavioural
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 guidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants enrolled into the intervention group receive specific sleep ergonomics guidance Receives: Behavioral: Specific sleep ergonomics guidance |
| Control group | Active comparator | Participants enrolled into the control group will receive general sleep ergonomics guidance Receives: Behavioral: General sleep ergonomics guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from baseline to 12 month follow-up
Secondary outcomes (2)
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.
Measured: Change from baseline to 12 month follow-up
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.
Measured: Change from baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start3 Oct 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jari Ylinen, Central Finland Hospital District
- Investigators
- Jari Ylinen, MD, Principal investigator, Central Finland Hospital District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342885
- Sponsor's protocol ID
- Dnro1E/2017
- Acronym
- SLEEPLBP
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Ergonomics on Pain Low Back Pain
- ClinicalTrials.gov ID
- NCT03342885
- Acronym / sponsor ID
- SLEEPLBP / Dnro1E/2017
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Sleep ergonomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Specific sleep ergonomics guidanceParticipants enrolled into the intervention group receive specific sleep ergonomics guidance |
| Control group | Active comparator | Behavioral: General sleep ergonomics guidanceParticipants enrolled into the control group will receive general sleep ergonomics guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low Back Pain
- Pain during sleep or
Key exclusion criteria (4 listed)
- Fibromyalgia
- Inflammatory rheumatic disease
- Severe depression or other psychiatric diagnosis
- Previously received specific guidance in sleep ergonomics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific sleep ergonomics guidanceParticipants 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. | Behavioural | Intervention group |
| General sleep ergonomics guidanceParticipants 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. | Behavioural | Control group |
Primary outcome
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).
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.
2 secondary outcomes
Reported amount of sleep
Time frame: Change from baseline to 12 month follow-up
Number of sick leave days
Time frame: Change from baseline to 12 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Ylinen, MD principal investigator
Central Finland Hospital District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific sleep ergonomics guidance and General sleep ergonomics guidance in people with Low Back Pain, run by Central Finland Hospital District at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juhani Multanen, PhD (35850 555 1933, juhani.multanen@ksshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Visual Analog Scale (VAS) (time frame: Change from baseline to 12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.