Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study

Study Overview
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Brief Summary
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Up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this disability is mild to moderate (WPN3-). Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary rehabilitation settings but might also benefit from treatments based on these multidisciplinary rehabilitation treatment principles when provided by specifically trained primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the feasibility of a specifically for primary care physiotherapist developed biopsychosocial intervention (Back on Track intervention) in WPN3- classified patients, and to evaluate whether this Back on Track intervention results in a significant improvement in functional disability in this subgroup of patients.

Official Title
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A Primary Care Biopsychosocial Intervention (Back on Track) for Patients With Chronic Low Back Pain in Which Psychosocial Factors Moderately Influence Daily Life Functioning: a Pilot Study

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Back on Track intervention


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 (WPN3-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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Back on Track intervention<br>A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions. | Other: Back on Track intervention<br>* A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.<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 catastrophizing 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 (TSK) |  | 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 | 
| 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 | 
| Social demographic questionnaire |  | pre-treatment (baseline) | 
| Treatment satisfaction questionnaire | This questionnaire will include questions about the patient's opinion regarding the intervention, the workbook, the consultant in rehabilitation medicine, the therapist(s), and the patient's perceived knowledge | post-treatment (with an expected average of 8 weeks) | 
| 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 | 
| Protocol adherence | Physiotherapists will audio record all therapy sessions. A random sample will be assessed for protocol adherence using a modified version of the protocol used by Leeuw et al (2009). This protocol includes essential treatment elements and raters will judge whether these essential treatments elements are provided during the therapy or not. Adherence will be regarded sufficient in case a percentage of 70% of the required treatment elements are provided during the treatment. | All therapy sessions of the Back on Track intervention will be audio recorded (the intervention period of the trial will last approximately one year and 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Chronic Pain, Cognitive Behavioral Therapy, Primary Health Care, Physical Therapy