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Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Classification Based Cognitive Functional Therapy
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Pain, Back Pain, Low Back Pain, Chronic Low Back Pain, Cognitive Functional Therapy, Intervention, Subclassification, Multidimensional

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Low Back Pain (LBP) with/without referred pain in buttock/thigh for > 3 months, including the four weeks prior to testing
  • LBP is primarily localised from T12 to gluteal folds
  • mechanical provocation of LBP with postures, movement and activities
  • average pain intensity in the past week Numerical Rating Scale (NRS) >/= 1/10
  • Disability (ODI) >/=2%
  • willingness to sign the informed consent

Exclusion Criteria:

  • specific spinal pathology
  • presence of red flags
  • previous lumbar spinal surgery
  • pregnancy
  • diagnosed psychiatric disorder - somatisation
  • radicular pain with positive neural tissue provocation test
  • widespread non-specific pain disorder (no primary LBP focus)
  • specific diagnoses: active rheumatologic disease, progressive neurological disease, serious cardiac or other internal medical condition, malignant basic diseases, acute traumas, infections, or acute vascular catastrophes

Sites / Locations

  • Lindelo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Classification Based Cognitive Functional Therapy

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in pain
Pain was assessed using a numerical pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Change from baseline in disability
Disability was measured using the Oswestry Disability Index (ODI)

Secondary Outcome Measures

Change from baseline in Beliefs about LBP
Back Beliefs Questionnaire (BBQ)
Change from baseline in Chance of long-term disability and failure to return to work
Tha Acute Low Back Pain Screening Questionnaire (Dutch version of the Ørebro Pain Screening Questionnaire) is a 'yellow flag' screening tool that predicts long-term disability and failure to return to work due to personal and environmental factors.
Change from baseline in Physical activity
Baecke questionnaire
Change from baseline in Sleep problems
Insomnia Severity Index (ISI)
Change from baseline in Depression, anxiety and stress
Depression Anxiety and Stress scale (DASS-21)
Change from baseline in Self-efficacy, coping
Pain Self-Efficacy Questionnaire (PSEQ)
Change from baseline in Fear-avoidance / kinesiophobia
Tampa Scale of Kinesiophobia (TSK-17)
Change from baseline in Pain catastrophizing
Pain Catastrophizing Scale (PCS)
Change from baseline in Psychosocial job aspects
The Job Content Questionnaire (JCQ) is a tool for psychosocial job assessment.
Change from baseline in Lower Lumbar spine Kinematics
Lower Lumbar kinematics of the spine were measured with the BodyGuard (sels-instruments nv). This is a remote measuring system.
Patient satisfaction of the intervention
Patients' Global Impression of Change (PGIC) scale
Change from baseline in Category of risk of poor outcome (persistent disabling symptoms)
The Start Back Screening Tool is used to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. The tool helps to group patients into 3 categories of risk of poor outcome (persistent disabling symptoms) - low, medium, and high-risk.
Change from baseline in Psychosocial aspects of work
Psychosocial Aspects of Work Questionnaire (PAWQ)

Full Information

First Posted
June 12, 2013
Last Updated
January 31, 2019
Sponsor
KU Leuven
Collaborators
European Social Fund
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1. Study Identification

Unique Protocol Identification Number
NCT01882686
Brief Title
Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain
Official Title
Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain - a Series of Case-controls
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
European Social Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A series of case-studies to explore the efficacy of classification based cognitive functional physiotherapy according to the classification system proposed by Peter O'Sullivan in specific nursing population with non specific chronic low back pain. The investigators hypothesis was that treatment targeting the mechanisms behind the problem from a multidimensional perspective would be effective to reduce pain, disability and sick-leave.
Detailed Description
Low back pain (LBP) is a common, recalcitrant and costly health problem, which limits patients' daily activities. In 85% of the cases, LBP is classified as 'non-specific', which means there is no clear underlying patho-anatomical/radiological abnormality. This subgroup often gives rise to a chronic fluctuating problem. Although most cases of LBP resolve within 8 to 12 weeks, it may become chronic in up to 15% of patients. LBP constitutes an enormous and growing medical and socio-economical problem for the modern society. Nursing has been identified amongst the top professions at risk for occupational LBP, with lifetime prevalence between 66%-82%. The impact of LBP for nurses includes time off work, increased risk of chronicity, associated personal and economic costs and reduced nursing workforce efficiency. Non Specific Chronic Low Back Pain (NSCLBP) is widely viewed as a multifactorial biopsychosocial pain syndrome. It has been proposed by several authors that NSCLBP represents a vicious cycle associated with different combinations of maladaptive; cognitive (negative beliefs, fear avoidance behaviours, catastrophising, depression, stress, lack of pacing and coping), physical (pain provocative postures, movement patterns and pain behaviours) and lifestyle (inactivity, rest) behaviours that act to promote pain and disability. However a recent systematic review suggests that this change in paradigm and the investigators new understanding of NSCLBP has not resulted in clinical trials utilizing multidimensional classification systems or targeted interventions based on the underlying mechanisms. In line with this paradigm shift a novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their underlying pain mechanism. Enabling a classification based interventions targetting the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Pain, Back Pain, Low Back Pain, Chronic Low Back Pain, Cognitive Functional Therapy, Intervention, Subclassification, Multidimensional

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Classification Based Cognitive Functional Therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Classification Based Cognitive Functional Therapy
Other Intervention Name(s)
cognitive functional therapy
Intervention Description
A novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation. This subclassification is the base for matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder. The intervention is called 'cognitive functional therapy' as it directly challenges these behaviours in a functionally specific and graduated manner.
Primary Outcome Measure Information:
Title
Change from baseline in pain
Description
Pain was assessed using a numerical pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in disability
Description
Disability was measured using the Oswestry Disability Index (ODI)
Time Frame
3, 6, 9 months, 1 and 3 year
Secondary Outcome Measure Information:
Title
Change from baseline in Beliefs about LBP
Description
Back Beliefs Questionnaire (BBQ)
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Chance of long-term disability and failure to return to work
Description
Tha Acute Low Back Pain Screening Questionnaire (Dutch version of the Ørebro Pain Screening Questionnaire) is a 'yellow flag' screening tool that predicts long-term disability and failure to return to work due to personal and environmental factors.
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Physical activity
Description
Baecke questionnaire
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Sleep problems
Description
Insomnia Severity Index (ISI)
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Depression, anxiety and stress
Description
Depression Anxiety and Stress scale (DASS-21)
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Self-efficacy, coping
Description
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Fear-avoidance / kinesiophobia
Description
Tampa Scale of Kinesiophobia (TSK-17)
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Pain catastrophizing
Description
Pain Catastrophizing Scale (PCS)
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Psychosocial job aspects
Description
The Job Content Questionnaire (JCQ) is a tool for psychosocial job assessment.
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Lower Lumbar spine Kinematics
Description
Lower Lumbar kinematics of the spine were measured with the BodyGuard (sels-instruments nv). This is a remote measuring system.
Time Frame
3, 6, 9 and 12 months
Title
Patient satisfaction of the intervention
Description
Patients' Global Impression of Change (PGIC) scale
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Category of risk of poor outcome (persistent disabling symptoms)
Description
The Start Back Screening Tool is used to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. The tool helps to group patients into 3 categories of risk of poor outcome (persistent disabling symptoms) - low, medium, and high-risk.
Time Frame
3, 6, 9 and 12 months
Title
Change from baseline in Psychosocial aspects of work
Description
Psychosocial Aspects of Work Questionnaire (PAWQ)
Time Frame
3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Low Back Pain (LBP) with/without referred pain in buttock/thigh for > 3 months, including the four weeks prior to testing LBP is primarily localised from T12 to gluteal folds mechanical provocation of LBP with postures, movement and activities average pain intensity in the past week Numerical Rating Scale (NRS) >/= 1/10 Disability (ODI) >/=2% willingness to sign the informed consent Exclusion Criteria: specific spinal pathology presence of red flags previous lumbar spinal surgery pregnancy diagnosed psychiatric disorder - somatisation radicular pain with positive neural tissue provocation test widespread non-specific pain disorder (no primary LBP focus) specific diagnoses: active rheumatologic disease, progressive neurological disease, serious cardiac or other internal medical condition, malignant basic diseases, acute traumas, infections, or acute vascular catastrophes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Dankaerts
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lindelo
City
Lille
State/Province
Antwerpen
ZIP/Postal Code
2275
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23208945
Citation
Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvale A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial. Eur J Pain. 2013 Jul;17(6):916-28. doi: 10.1002/j.1532-2149.2012.00252.x. Epub 2012 Dec 4.
Results Reference
background
PubMed Identifier
16154380
Citation
O'Sullivan P. Diagnosis and classification of chronic low back pain disorders: maladaptive movement and motor control impairments as underlying mechanism. Man Ther. 2005 Nov;10(4):242-55. doi: 10.1016/j.math.2005.07.001. Epub 2005 Sep 9.
Results Reference
background
PubMed Identifier
21094624
Citation
Dankaerts W, O'Sullivan P. The validity of O'Sullivan's classification system (CS) for a sub-group of NS-CLBP with motor control impairment (MCI): overview of a series of studies and review of the literature. Man Ther. 2011 Feb;16(1):9-14. doi: 10.1016/j.math.2010.10.006. Epub 2010 Nov 20.
Results Reference
background
PubMed Identifier
32949123
Citation
Van Hoof W, O'Sullivan K, Verschueren S, O'Sullivan P, Dankaerts W. Evaluation of Absenteeism, Pain, and Disability in Nurses With Persistent Low Back Pain Following Cognitive Functional Therapy: A Case Series Pilot Study With 3-Year Follow-Up. Phys Ther. 2021 Jan 4;101(1):pzaa164. doi: 10.1093/ptj/pzaa164.
Results Reference
derived

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Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain

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