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

February 1, 2018 updated by: Maastricht University Medical Center

A Primary Care Biopsychosocial Intervention (Back on Track) for Patients With Chronic Low Back Pain in Which Psychosocial Factors Moderately Influence Daily Life Functioning: a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Bunde, Limburg, Netherlands, 6235 BG
        • Fysiotherapie Abbink
      • Maastricht, Limburg, Netherlands, 6216 PJ
        • Fysiohof
      • Maastricht, Limburg, Netherlands, 6229 EZ
        • ICM Fysio
      • Margraten, Limburg, Netherlands, 6269 BL
        • Fysiotherapie Breuers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (WPN3-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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Back on Track intervention
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
A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Directly after the first treatment (in the first week of the intervention)
Directly after the first treatment (in the first week of the intervention)
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
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)
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
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)
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
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
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
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
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
Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Numeric Rating Scale (NRS)
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
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
Tampa Scale of Kinesiophobia (TSK)
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
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
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
Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Social demographic questionnaire
Time Frame: pre-treatment (baseline)
pre-treatment (baseline)
Treatment satisfaction questionnaire
Time Frame: post-treatment (with an expected average of 8 weeks)
This questionnaire will include questions about the patient's opinion regarding the intervention, the workbook, the consultant in rehabilitation medicine, the therapist(s), and the patient's perceived knowledge
post-treatment (with an expected average of 8 weeks)
Protocol adherence
Time Frame: All therapy sessions of the Back on Track intervention will be audio recorded (the intervention period of the trial will last approximately one year and 3 months)
Physiotherapists will audio record all therapy sessions. A random sample will be assessed for protocol adherence using a modified version of the protocol used by Leeuw et al (2009). This protocol includes essential treatment elements and raters will judge whether these essential treatments elements are provided during the therapy or not. Adherence will be regarded sufficient in case a percentage of 70% of the required treatment elements are provided during the treatment.
All therapy sessions of the Back on Track intervention will be audio recorded (the intervention period of the trial will last approximately one year and 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Ivan PJ Huijnen, Dr., Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-3-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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