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Completed

NCT Number: NCT01882686

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lindelo

Lille, Antwerpen, 2275, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Classification Based Cognitive Functional Therapy

Other

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 names: cognitive functional therapy

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • European Social Fund

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jun 20, 2013
Registry last updated
Feb 4, 2019

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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