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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882686
• Other study ID #: S54606
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: March 2016

Study information

• Verified date: January 2019
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2016
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Belgium	Lindelo	Lille	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	European Social Fund

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. Review. — View 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. Epub 2005 Sep 9. Review. — View Citation

Vibe Fersum K, O'Sullivan P, Skouen JS, Smith A, Kvåle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3, 6, 9 and 12 months
Primary	Change from baseline in disability	Disability was measured using the Oswestry Disability Index (ODI)	3, 6, 9 months, 1 and 3 year
Secondary	Change from baseline in Beliefs about LBP	Back Beliefs Questionnaire (BBQ)	3, 6, 9 and 12 months
Secondary	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.	3, 6, 9 and 12 months
Secondary	Change from baseline in Physical activity	Baecke questionnaire	3, 6, 9 and 12 months
Secondary	Change from baseline in Sleep problems	Insomnia Severity Index (ISI)	3, 6, 9 and 12 months
Secondary	Change from baseline in Depression, anxiety and stress	Depression Anxiety and Stress scale (DASS-21)	3, 6, 9 and 12 months
Secondary	Change from baseline in Self-efficacy, coping	Pain Self-Efficacy Questionnaire (PSEQ)	3, 6, 9 and 12 months
Secondary	Change from baseline in Fear-avoidance / kinesiophobia	Tampa Scale of Kinesiophobia (TSK-17)	3, 6, 9 and 12 months
Secondary	Change from baseline in Pain catastrophizing	Pain Catastrophizing Scale (PCS)	3, 6, 9 and 12 months
Secondary	Change from baseline in Psychosocial job aspects	The Job Content Questionnaire (JCQ) is a tool for psychosocial job assessment.	3, 6, 9 and 12 months
Secondary	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.	3, 6, 9 and 12 months
Secondary	Patient satisfaction of the intervention	Patients' Global Impression of Change (PGIC) scale	3, 6, 9 and 12 months
Secondary	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.	3, 6, 9 and 12 months
Secondary	Change from baseline in Psychosocial aspects of work	Psychosocial Aspects of Work Questionnaire (PAWQ)	3, 6, 9 and 12 months