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

NCT ID: NCT01882686

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Classification Based Cognitive Functional Therapy

Group Type EXPERIMENTAL

Classification Based Cognitive Functional Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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cognitive functional therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Social Fund

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. Wim Dankaerts

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wim Dankaerts

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Lindelo

Lille, Antwerpen, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 23208945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16154380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21094624 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32949123 (View on PubMed)

Other Identifiers

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S54606

Identifier Type: -

Identifier Source: org_study_id

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