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

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 - Chronic low back pain rehabilitation in primary care: an RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41907

Enrollment

Registered

2014-07-22

Start date

2014-08-27

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The new primary care intervention *Back on Track* (intervention) The *Back on Track* intervention comprises four individual sessions (30 minutes) and eight group sessions (60 minutes), provided by ph

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Functional Disability: Quebec Back Pain Disability Scale (QBPDS)	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)