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Completed

NCT Number: NCT02220543

Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fysiotherapie Giessen-Ploemen, Bunde, Limburg, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Adelante, Centre of Expertise in Rehabilitation and Audiology
  • CZ Fonds
  • The Province of Limburg

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 20, 2014
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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