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Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

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ClinicalTrials.gov Identifier: NCT02220543
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 29, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Low Back Pain Chronic Pain Musculoskeletal Pain Other: Back on Track intervention Other: Primary care as usual

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2014
Primary Completion Date : August 2017
Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Back on Track intervention
Back on Track intervention is a biopsychosocial primary care 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.
Other: 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.
Active Comparator: Primary care as usual
Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.
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.
Other: 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.


Outcome Measures

Primary Outcome Measures :
  1. Quebec Back Pain Disability Scale (QBPDS) [ 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 ]
    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 :
  1. Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Directly after the first treatment (in the first week of the intervention) ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Social demographic questionnaire [ Time Frame: pre-treatment ]
  11. Treatment questionnaire [ Time Frame: Post-treatment (with an expected average of 8 weeks) ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220543


Locations
Netherlands
Fysiotherapie Giessen-Ploemen
Bunde, Limburg, Netherlands, 6241 DK
Fysiohof
Maastricht, Limburg, Netherlands, 6216 PJ
Fysio Zuyd Caberg
Maastricht, Limburg, Netherlands, 6217 CR
Fysiotherapiepraktijk Yvonne Janss
Maastricht, Limburg, Netherlands, 6227 BG
ICM Fysio
Maastricht, Limburg, Netherlands, 6229 EZ
Fysiotherapie Breuers
Margraten, Limburg, Netherlands, 6269 BL
Fysiotherapie Abbink
Ulestraten, Limburg, Netherlands, 6235 BG
Fysio Valkenburg
Valkenburg, Limburg, Netherlands, 6301 GH
Sponsors and Collaborators
Maastricht University Medical Center
Adelante, Centre of Expertise in Rehabilitation and Audiology
The Province of Limburg
CZ Fonds
Investigators
Principal Investigator: Ivan PJ Huijnen, Dr. Maastricht University
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02220543     History of Changes
Other Study ID Numbers: 14-3-019
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Maastricht University Medical Center:
Cognitive behavioral therapy
Primary health care
Physical Therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases