Non-specific chronic low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
Participants are randomised to one of four treatment groups:
1. Information and advice: Participants are given oral and written information in a booklet on how to manage non-specific chronic low back
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study includes individuals willing to participate in any of the included treatment groups; either in chiropractic care and physiotherapy, chiropractic care, physiotherapy or information and advice. The inclusion criteria are: 1. Pain below located costal margin and above the inferior gluteal folds 2. Reoccurring low back pain for at least 3 months 3. Age between 18 to 60 years 4. Can stand or walk independently 5. Swedish speaking and literate
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria (as of 22/12/2017): 1. Pain attributable to a known specific pathology 2. Lack of written informed consent 3. Pregnancy or less than 6 months postpartum or post weaning 4. Had any of the treatments defined in the chiropractic care and physiotherapy in the previous 1 month 5. Not showing up at baseline after randomisation Previous participant exclusion criteria: 1. Pain attributable to a known specific pathology 2. Lack of written informed consent 3. Patient planning for surgery for low back pain during the study period or had surgery 3 month before 4. Pregnancy or less than 6 months postpartum or post weaning 5. Had any of the treatments defined in the chiropractic care and physiotherapy in the previous 1 month 6. Not showing up at baseline after randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Back pain-related functional limitation, measured using the Oswestry Disability Index (ODI) at baseline, 12, 26 and 52 weeks after baseline. The 26-week outcome measure is used as the primary endpoint and all other time-points are defined as secondary. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Back pain intensity, measured using the Numeric Rating Scale (NRS) 2. General health, measured using a self-rated health (SRH) question 3. Health-related quality-of-life, measured using the EQ-5D 4. Working status, defined as the percentage of full time work Measured at baseline, 12, 26 and 52 weeks Exploratory outcomes: 1. Costs: Direct (costs for pharmaceuticals, health care visits, clinical examinations, and hospital stay) and indirect costs (costs of changes in productivity) estimated during 12 months after randomization. The resource quantities collected at baseline, 12, 26 and 52 weeks after baseline 2. Effectiveness: Quality adjusted life years (QALYs) during 12 months after baseline, estimated using the quality of life weights based on EQ-5D (measured at baseline, 12, 26 and 52 weeks after baseline) | — |
Countries
Sweden
Outcome results
None listed