Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

NCT02220543 | Completed DMC

• 1 other identifier: 14-3-019
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

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).

Conditions

Low Back Pain; Chronic Pain; Musculoskeletal Pain

Keywords

Cognitive behavioral therapy; Primary health care; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

Back on Track intervention

EXPERIMENTAL

Back on Track intervention is a biopsychosocial primary care intervention

Other: Back on Track intervention; Other: Primary care as usual

Primary care as usual

ACTIVE COMPARATOR

Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.

Other: Back on Track intervention; Other: Primary care as usual

Interventions

Back on Track intervention OTHER

Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.

Back on Track intervention; Primary care as usual

Primary care as usual OTHER

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.

Back on Track intervention; Primary care as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Adelante, Centre of Expertise in Rehabilitation and Audiology: collaborator
• The Province of Limburg: collaborator
• CZ Fonds: collaborator

Study Sites (8)

Fysiotherapie Giessen-Ploemen

Bunde, Limburg, 6241 DK, Netherlands

Location

Fysiohof

Maastricht, Limburg, 6216 PJ, Netherlands

Location

Fysio Zuyd Caberg

Maastricht, Limburg, 6217 CR, Netherlands

Location

Fysiotherapiepraktijk Yvonne Janss

Maastricht, Limburg, 6227 BG, Netherlands

Location

ICM Fysio

Maastricht, Limburg, 6229 EZ, Netherlands

Location

Fysiotherapie Breuers

Margraten, Limburg, 6269 BL, Netherlands

Location

Fysiotherapie Abbink

Ulestraten, Limburg, 6235 BG, Netherlands

Location

Fysio Valkenburg

Valkenburg, Limburg, 6301 GH, Netherlands

Location

Related Publications (8)

• Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.

  PMID: 10781906 BACKGROUND

• Lindstrom 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. doi: 10.1093/ptj/72.4.279.

  PMID: 1533941 BACKGROUND

• Leeuw M, Goossens MEJB, van Breukelen GJP, de Jong JR, Heuts PHTG, Smeets RJEM, Koke AJA, Vlaeyen JWS. 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.

  PMID: 18242858 BACKGROUND

• 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.

  PMID: 20189241 BACKGROUND

• 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.

  PMID: 20395306 BACKGROUND

• 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.

  PMID: 22607157 BACKGROUND

• 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.

  PMID: 27641497 DERIVED

• 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.

  PMID: 25922158 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Musculoskeletal Pain

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ivan PJ Huijnen, Dr.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

NL (8)