Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

Not Applicable

Completed

• Conditions: Low Back Pain; Chronic Pain; Musculoskeletal Pain
• Interventions: Other: Back on Track intervention; Other: Primary care as usual

• Registration Number: NCT02220543
• Lead Sponsor: Maastricht University Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-20
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Back on Track intervention	Primary care as usual	Back on Track intervention is a biopsychosocial primary care intervention
Primary care as usual	Back on Track intervention	Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.
Back on Track intervention	Back on Track intervention	Back on Track intervention is a biopsychosocial primary care intervention
Primary care as usual	Primary care as usual	Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.

Primary Outcome Measures

Name	Time	Method
Quebec Back Pain Disability Scale (QBPDS)	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 Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (8)

Fysiotherapie Abbink; 🇳🇱 Ulestraten, Limburg, Netherlands

Fysiotherapie Giessen-Ploemen; 🇳🇱 Bunde, Limburg, Netherlands

Fysiohof; 🇳🇱 Maastricht, Limburg, Netherlands

Fysio Zuyd Caberg; 🇳🇱 Maastricht, Limburg, Netherlands

Fysiotherapiepraktijk Yvonne Janss; 🇳🇱 Maastricht, Limburg, Netherlands

Fysio Valkenburg; 🇳🇱 Valkenburg, Limburg, Netherlands

ICM Fysio; 🇳🇱 Maastricht, Limburg, Netherlands

Fysiotherapie Breuers; 🇳🇱 Margraten, Limburg, Netherlands