Low Back Pain
Conditions
Keywords
Low Back Pain, Sleep ergonomics
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.
Interventions
BEHAVIORALSpecific 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.
BEHAVIORALGeneral 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.
Sponsors
Central Finland Hospital District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog Scale (VAS) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Reported amount of sleep | 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. |
| Number of sick leave days | 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. |
Countries
Finland
Contacts
Primary ContactJuhani Multanen, PhD
Outcome results
None listed