Costs and effectiveness of chiropractic care and physiotherapy in the treatment of chronic low back pai

Not Applicable

• Conditions: on-specific chronic low back pain; Musculoskeletal Diseases; Low back pain

• Registration Number: ISRCTN15830360
• Lead Sponsor: Karolinska Institutet

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29273083

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-20
• Last Update Posted: 3 February 2020
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 95

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Back pain intensity, measured using the Numeric Rating Scale (NRS)<br> 2. General health, measured using a self-rated health (SRH) question<br> 3. Health-related quality-of-life, measured using the EQ-5D<br> 4. Working status, defined as the percentage of full time work<br> Measured at baseline, 12, 26 and 52 weeks<br><br> Exploratory outcomes:<br> 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<br> 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)<br>