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

Primary Purpose

Chronic Low Back Pain

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

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low Back Pain, Chronic Pain, 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 (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.

Sites / Locations

  • Fysiotherapie Abbink
  • Fysiohof
  • ICM Fysio
  • Fysiotherapie Breuers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Back on Track intervention

Arm Description

A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.

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 (TSK)
Global Perceived Effect (GPE)
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)
Social demographic questionnaire
Treatment satisfaction questionnaire
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
Pain Self-Efficacy Questionnaire (PSEQ)
Protocol adherence
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.

Full Information

First Posted
September 16, 2014
Last Updated
February 1, 2018
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
NCT02245919
Brief Title
Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study
Official Title
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
Study Type
Interventional

2. Study Status

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Low Back Pain, Chronic Pain, Cognitive Behavioral Therapy, Primary Health Care, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Back on Track intervention
Arm Type
Experimental
Arm Description
A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
Intervention Type
Other
Intervention Name(s)
Back on Track intervention
Intervention Description
A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
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 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
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
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
Title
Social demographic questionnaire
Time Frame
pre-treatment (baseline)
Title
Treatment satisfaction questionnaire
Description
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
Time Frame
post-treatment (with an expected average of 8 weeks)
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
Protocol adherence
Description
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.
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)

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 (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan PJ Huijnen, Dr.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fysiotherapie Abbink
City
Bunde
State/Province
Limburg
ZIP/Postal Code
6235 BG
Country
Netherlands
Facility Name
Fysiohof
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6216 PJ
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

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

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