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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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ClinicalTrials.gov Identifier: NCT01882686
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
European Social Fund
Information provided by (Responsible Party):
Prof. dr. Wim Dankaerts, KU Leuven

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: Classification Based Cognitive Functional Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Classification Based Cognitive Functional Therapy Other: Classification Based Cognitive Functional Therapy
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.
Other Name: cognitive functional therapy




Primary Outcome Measures :
  1. Change from baseline in pain [ Time Frame: 3, 6, 9 and 12 months ]
    Pain was assessed using a numerical pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst imaginable pain)

  2. Change from baseline in disability [ Time Frame: 3, 6, 9 months, 1 and 3 year ]
    Disability was measured using the Oswestry Disability Index (ODI)


Secondary Outcome Measures :
  1. Change from baseline in Beliefs about LBP [ Time Frame: 3, 6, 9 and 12 months ]
    Back Beliefs Questionnaire (BBQ)

  2. Change from baseline in Chance of long-term disability and failure to return to work [ Time Frame: 3, 6, 9 and 12 months ]
    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.

  3. Change from baseline in Physical activity [ Time Frame: 3, 6, 9 and 12 months ]
    Baecke questionnaire

  4. Change from baseline in Sleep problems [ Time Frame: 3, 6, 9 and 12 months ]
    Insomnia Severity Index (ISI)

  5. Change from baseline in Depression, anxiety and stress [ Time Frame: 3, 6, 9 and 12 months ]
    Depression Anxiety and Stress scale (DASS-21)

  6. Change from baseline in Self-efficacy, coping [ Time Frame: 3, 6, 9 and 12 months ]
    Pain Self-Efficacy Questionnaire (PSEQ)

  7. Change from baseline in Fear-avoidance / kinesiophobia [ Time Frame: 3, 6, 9 and 12 months ]
    Tampa Scale of Kinesiophobia (TSK-17)

  8. Change from baseline in Pain catastrophizing [ Time Frame: 3, 6, 9 and 12 months ]
    Pain Catastrophizing Scale (PCS)

  9. Change from baseline in Psychosocial job aspects [ Time Frame: 3, 6, 9 and 12 months ]
    The Job Content Questionnaire (JCQ) is a tool for psychosocial job assessment.

  10. Change from baseline in Lower Lumbar spine Kinematics [ Time Frame: 3, 6, 9 and 12 months ]
    Lower Lumbar kinematics of the spine were measured with the BodyGuard (sels-instruments nv). This is a remote measuring system.

  11. Patient satisfaction of the intervention [ Time Frame: 3, 6, 9 and 12 months ]
    Patients' Global Impression of Change (PGIC) scale

  12. Change from baseline in Category of risk of poor outcome (persistent disabling symptoms) [ Time Frame: 3, 6, 9 and 12 months ]
    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.

  13. Change from baseline in Psychosocial aspects of work [ Time Frame: 3, 6, 9 and 12 months ]
    Psychosocial Aspects of Work Questionnaire (PAWQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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): NCT01882686


Locations
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Belgium
Lindelo
Lille, Antwerpen, Belgium, 2275
Sponsors and Collaborators
KU Leuven
European Social Fund
Investigators
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Principal Investigator: Wim Dankaerts KU Leuven
Publications:
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Responsible Party: Prof. dr. Wim Dankaerts, Prof. dr., KU Leuven
ClinicalTrials.gov Identifier: NCT01882686    
Other Study ID Numbers: S54606
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Prof. dr. Wim Dankaerts, KU Leuven:
Pain
Back Pain
Low Back Pain
Chronic Low Back Pain
Cognitive Functional Therapy
Intervention
Subclassification
Multidimensional
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations