Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220543
• Other study ID #: 14-3-019
• Status: Completed
• Phase: N/A
• First received: August 14, 2014
• Last updated: August 28, 2017
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Musculoskeletal Pain

Intervention

Other:
• Back on Track intervention
Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
• Primary care as usual
Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.

Locations

Country	Name	City	State
Netherlands	Fysiotherapie Giessen-Ploemen	Bunde	Limburg
Netherlands	Fysio Zuyd Caberg	Maastricht	Limburg
Netherlands	Fysiohof	Maastricht	Limburg
Netherlands	Fysiotherapiepraktijk Yvonne Janss	Maastricht	Limburg
Netherlands	ICM Fysio	Maastricht	Limburg
Netherlands	Fysiotherapie Breuers	Margraten	Limburg
Netherlands	Fysiotherapie Abbink	Ulestraten	Limburg
Netherlands	Fysio Valkenburg	Valkenburg	Limburg

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Adelante, Centre of Expertise in Rehabilitation and Audiology, CZ Fonds, The Province of Limburg

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. Review. — View Citation

Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25. — View Citation

Leeuw M, Goossens ME, van Breukelen GJ, de Jong JR, Heuts PH, Smeets RJ, Köke AJ, Vlaeyen JW. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008 Aug 15;138(1):192-207. doi: 10.1016/j.pain.2007.12.009. Epub 2008 Feb 1. — View Citation

Lindström I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. — View 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. Review. — View Citation

Vlaeyen JW, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quebec Back Pain Disability Scale (QBPDS)	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.	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	Credibility and Expectancy Questionnaire (CEQ)		Directly after the first treatment (in the first week of the intervention)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Social demographic questionnaire		pre-treatment
Secondary	Treatment questionnaire	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.	Post-treatment (with an expected average of 8 weeks)