The Effectiveness of a Biopsychosocial Rehabilitation Program in Primary Care (Back on Track) Versus Primary Care as Usual in Patients With Chronic Low Back Pain in Which Psychosocial Factors Minimally Influence Daily Life Functioning: a Randomized Controlled Trial

Maastricht University Medical Center8 sites in 1 country25 target enrollmentAugust 2014

ConditionsLow Back Pain Chronic Pain Musculoskeletal Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Maastricht University Medical Center
Enrollment: 25
Locations: 8
Primary Endpoint: Quebec Back Pain Disability Scale (QBPDS)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new primary care intervention "Back on Track" as compared to usual primary care in patients with non-specific chronic low back pain in which disability levels are moderate and the role of psychosocial factors to this disability is at maximum low (classified as WPN2).

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

August 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months.
•Presence of contributing social and psychological factors, however not complex (WPN2 classification)
•Age between 18 and 65 year
•Sufficient knowledge of the Dutch language
•Acceptance towards the biopsychosocial approach instead of biomedical approach

Exclusion Criteria

•Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome
•Pregnancy
•Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.

Outcomes

Primary Outcomes

Quebec Back Pain Disability Scale (QBPDS)

Time Frame: Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up

The QBPDS is a 20-itemed questionnaire designed to determine the individuals' functional disability level (ranging from 0-100). A higher score reflects higher disability.

Secondary Outcomes

Credibility and Expectancy Questionnaire (CEQ)(Directly after the first treatment (in the first week of the intervention))
EuroQol-5D (EQ-5D)(Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
Hospital Anxiety and Depression Scale (HADS)(Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
Pain Catastrophizing Scale (PCS)(Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
Numeric Rating Scale (NRS)(Change in pain intensity between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
Tampa Scale of Kinesiophobia(Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
Pain Self-Efficacy Questionnaire (PSEQ)(Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
Global Perceived Effect (GPE)(Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up)
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)(Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up after the end of the treatment)
Social demographic questionnaire(pre-treatment)
Treatment questionnaire(Post-treatment (with an expected average of 8 weeks))