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

Completed

Conditions: a-specifieke chronische lage rugklachten
persistent low back complaints
non-specific chronic low back pain

Registration Number: NL-OMON41907

Lead Sponsor: niversiteit Maastricht

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Functional Disability: Quebec Back Pain Disability Scale (QBPDS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of Life: EuroQol (EQ-5D)<br /><br>Anxiety & Depression: Hospital Anxiety and Depression Scale (HADS)<br /><br>Catastrophizing: Pain Catastrophizing Scale (PCS)<br /><br>Pain intensity: Numeric Rating Scale (NRS)<br /><br>Kinesiophobia: Tampa Scale of Kinesiophobia (TSK)<br /><br>Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ)<br /><br>Credibility & Expectancy: Credibility Expectancy Questionnaire (CEQ)<br /><br>Perceived effect: Global Perceived Effect (GPE)<br /><br>Cost diary: Trimbos and iMTA questionnaire on Costs associated with Psychiatric<br /><br>illness (TiC-P)<br /><br>Social demographic characteristics of the patient: general questionnaire<br /><br>including social demographic characteristics (age, gender, nationality, home<br /><br>situation, educational level, employment status, health status)</p><br>