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Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

Primary Purpose

Low Back Pain, Chronic Pain, Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Back on Track intervention
Primary care as usual
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Cognitive behavioral therapy, Primary health care, Physical Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fysiotherapie Giessen-Ploemen
  • Fysiohof
  • Fysio Zuyd Caberg
  • Fysiotherapiepraktijk Yvonne Janss
  • ICM Fysio
  • Fysiotherapie Breuers
  • Fysiotherapie Abbink
  • Fysio Valkenburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Back on Track intervention

Primary care as usual

Arm Description

Back on Track intervention is a biopsychosocial primary care intervention

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Credibility and Expectancy Questionnaire (CEQ)
EuroQol-5D (EQ-5D)
Hospital Anxiety and Depression Scale (HADS)
Pain Catastrophizing Scale (PCS)
Numeric Rating Scale (NRS)
Tampa Scale of Kinesiophobia
Pain Self-Efficacy Questionnaire (PSEQ)
Global Perceived Effect (GPE)
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)
Social demographic questionnaire
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.

Full Information

First Posted
August 14, 2014
Last Updated
August 28, 2017
Sponsor
Maastricht University Medical Center
Collaborators
Adelante, Centre of Expertise in Rehabilitation and Audiology, The Province of Limburg, CZ Fonds
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1. Study Identification

Unique Protocol Identification Number
NCT02220543
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Adelante, Centre of Expertise in Rehabilitation and Audiology, The Province of Limburg, CZ Fonds

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Pain, Musculoskeletal Pain
Keywords
Cognitive behavioral therapy, Primary health care, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Back on Track intervention
Arm Type
Experimental
Arm Description
Back on Track intervention is a biopsychosocial primary care intervention
Arm Title
Primary care as usual
Arm Type
Active Comparator
Arm Description
Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Back on Track intervention
Intervention Description
Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
Intervention Type
Other
Intervention Name(s)
Primary care as usual
Intervention Description
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 Outcome Measure Information:
Title
Quebec Back Pain Disability Scale (QBPDS)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Credibility and Expectancy Questionnaire (CEQ)
Time Frame
Directly after the first treatment (in the first week of the intervention)
Title
EuroQol-5D (EQ-5D)
Time Frame
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
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
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
Title
Pain Catastrophizing Scale (PCS)
Time Frame
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
Title
Numeric Rating Scale (NRS)
Time Frame
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
Title
Tampa Scale of Kinesiophobia
Time Frame
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
Title
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame
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
Title
Global Perceived Effect (GPE)
Time Frame
Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Title
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)
Time Frame
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
Title
Social demographic questionnaire
Time Frame
pre-treatment
Title
Treatment questionnaire
Description
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.
Time Frame
Post-treatment (with an expected average of 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan PJ Huijnen, Dr.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fysiotherapie Giessen-Ploemen
City
Bunde
State/Province
Limburg
ZIP/Postal Code
6241 DK
Country
Netherlands
Facility Name
Fysiohof
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6216 PJ
Country
Netherlands
Facility Name
Fysio Zuyd Caberg
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6217 CR
Country
Netherlands
Facility Name
Fysiotherapiepraktijk Yvonne Janss
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6227 BG
Country
Netherlands
Facility Name
ICM Fysio
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 EZ
Country
Netherlands
Facility Name
Fysiotherapie Breuers
City
Margraten
State/Province
Limburg
ZIP/Postal Code
6269 BL
Country
Netherlands
Facility Name
Fysiotherapie Abbink
City
Ulestraten
State/Province
Limburg
ZIP/Postal Code
6235 BG
Country
Netherlands
Facility Name
Fysio Valkenburg
City
Valkenburg
State/Province
Limburg
ZIP/Postal Code
6301 GH
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
10781906
Citation
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.
Results Reference
background
PubMed Identifier
1533941
Citation
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.
Results Reference
background
PubMed Identifier
18242858
Citation
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.
Results Reference
background
PubMed Identifier
20189241
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.
Results Reference
background
PubMed Identifier
20395306
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.
Results Reference
background
PubMed Identifier
22607157
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.
Results Reference
background
PubMed Identifier
27641497
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.
Results Reference
derived
PubMed Identifier
25922158
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. Erratum In: J Physiother. 2016 Apr;62(2):59.
Results Reference
derived

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Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

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