Clinical trial NCT02245919: Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Low Back Pain
Chronic Pain
Cognitive Behavioral Therapy
Primary Health Care
Physical Therapy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Adelante, Centre of Expertise in Rehabilitation and Audiology
name: The Province of Limburg
name: CZ Fonds
First posted: 2014-09-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 (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.

Primary outcomes:
measure: Quebec Back Pain Disability Scale (QBPDS)
timeFrame: 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 outcomes:
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Directly after the first treatment (in the first week of the intervention)
measure: EuroQol-5D (EQ-5D)
timeFrame: 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
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 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
measure: Numeric Rating Scale (NRS)
timeFrame: 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
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 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
measure: Global Perceived Effect (GPE)
timeFrame: Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)
timeFrame: Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Social demographic questionnaire
timeFrame: pre-treatment (baseline)
measure: Treatment satisfaction questionnaire
timeFrame: post-treatment (with an expected average of 8 weeks)
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: 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
measure: Protocol adherence
timeFrame: 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)
Other outcomes:
Locations:
city: Bunde
country: Netherlands
facility: Fysiotherapie Abbink
state: Limburg
city: Maastricht
country: Netherlands
facility: Fysiohof
state: Limburg
city: Maastricht
country: Netherlands
facility: ICM Fysio
state: Limburg
city: Margraten
country: Netherlands
facility: Fysiotherapie Breuers
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Ivan PJ Huijnen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Brunner E, De Herdt A, Minguet P, Baldew SS, Probst M. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil. 2013 Jan;35(1):1-10. doi: 10.3109/09638288.2012.683848. Epub 2012 May 21.