Clinical trial NCT02220543: Chronic Low Back Pain Rehabilitation in Primary Care: an RCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Pain
Musculoskeletal Pain
Keywords: 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: 2014-08-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 (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.

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 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
measure: Tampa Scale of Kinesiophobia
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: 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: 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 after the end of the treatment
measure: Social demographic questionnaire
timeFrame: pre-treatment
measure: Treatment questionnaire
timeFrame: Post-treatment (with an expected average of 8 weeks)
Other outcomes:
Locations:
city: Bunde
country: Netherlands
facility: Fysiotherapie Giessen-Ploemen
state: Limburg
city: Maastricht
country: Netherlands
facility: Fysiohof
state: Limburg
city: Maastricht
country: Netherlands
facility: Fysio Zuyd Caberg
state: Limburg
city: Maastricht
country: Netherlands
facility: Fysiotherapiepraktijk Yvonne Janss
state: Limburg
city: Maastricht
country: Netherlands
facility: ICM Fysio
state: Limburg
city: Margraten
country: Netherlands
facility: Fysiotherapie Breuers
state: Limburg
city: Ulestraten
country: Netherlands
facility: Fysiotherapie Abbink
state: Limburg
city: Valkenburg
country: Netherlands
facility: Fysio Valkenburg
state: Limburg
Study officials:
affiliation: Maastricht University
name: Ivan PJ Huijnen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Macedo LG, Smeets RJ, Maher CG, Latimer J, McAuley JH. Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther. 2010 Jun;90(6):860-79. doi: 10.2522/ptj.20090303. Epub 2010 Apr 15.
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.
citation: van Erp RMA, Huijnen IPJ, Koke AJA, Abbink FE, den Hollander M, Smeets RJEM. Development and content of the biopsychosocial primary care intervention 'Back on Track' for a subgroup of people with chronic low back pain. Physiotherapy. 2017 Jun;103(2):160-166. doi: 10.1016/j.physio.2016.04.004. Epub 2016 May 11.
citation: van Erp RM, Huijnen IP, Verbunt JA, Smeets RJ. A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial. J Physiother. 2015 Jul;61(3):155. doi: 10.1016/j.jphys.2015.03.003. Epub 2015 Apr 23.