Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study

NCT02245919 | Completed DMC

• 1 other identifier: 14-3-024
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Low Back Pain

Keywords

Low Back Pain; Chronic Pain; 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 (12)

• 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 catastrophizing 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 (1)

Back on Track intervention

EXPERIMENTAL

A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.

Other: Back on Track intervention

Interventions

Back on Track intervention OTHER

A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.

Back on Track intervention

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 (WPN3-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 (4)

Fysiotherapie Abbink

Bunde, Limburg, 6235 BG, Netherlands

Location

Fysiohof

Maastricht, Limburg, 6216 PJ, Netherlands

Location

ICM Fysio

Maastricht, Limburg, 6229 EZ, Netherlands

Location

Fysiotherapie Breuers

Margraten, Limburg, 6269 BL, Netherlands

Location

Related Publications (6)

• 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

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan PJ Huijnen, Dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 22, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2017-11

Locations

NL (4)