Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Chronic Pain, Musculoskeletal Pain, Low Back Pain

Intervention / Treatment
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* Other: Back on Track intervention
* Other: Primary care as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Back on Track intervention<br>Back on Track intervention is a biopsychosocial primary care intervention | Other: Back on Track intervention<br>* Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.<br>Other: Primary care as usual<br>* Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.<br>|
| Active Comparator: Primary care as usual<br>Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks. | Other: Back on Track intervention<br>* Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.<br>Other: Primary care as usual<br>* Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quebec Back Pain Disability Scale (QBPDS) | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This questionnaire contains only one question and asks patients directly after the treatment program has finished (post-treatment) to indicate whether they think they have received the new intervention or care as usual. | Post-treatment (with an expected average of 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioral therapy, Primary health care, Physical Therapy