Chronic Low Back Pain Rehabilitation in Primary Care: an RCT
NCT ID: NCT02220543
Last Updated: 2017-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2014-08-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Back on Track intervention
Back on Track intervention is a biopsychosocial primary care intervention
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.
Primary care as usual
Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Adelante, Centre of Expertise in Rehabilitation and Audiology
OTHER
The Province of Limburg
UNKNOWN
CZ Fonds
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ivan PJ Huijnen, Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Fysiotherapie Giessen-Ploemen
Bunde, Limburg, Netherlands
Fysiohof
Maastricht, Limburg, Netherlands
Fysio Zuyd Caberg
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, Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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14-3-019
Identifier Type: -
Identifier Source: org_study_id
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