Clinical trial NCT01882686: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Pain
Back Pain
Low Back Pain
Chronic Low Back Pain
Cognitive Functional Therapy
Intervention
Subclassification
Multidimensional
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: European Social Fund
First posted: 2013-06-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in pain
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in disability
timeFrame: 3, 6, 9 months, 1 and 3 year
Secondary outcomes:
measure: Change from baseline in Beliefs about LBP
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Chance of long-term disability and failure to return to work
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Physical activity
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Sleep problems
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Depression, anxiety and stress
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Self-efficacy, coping
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Fear-avoidance / kinesiophobia
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Pain catastrophizing
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Psychosocial job aspects
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Lower Lumbar spine Kinematics
timeFrame: 3, 6, 9 and 12 months
measure: Patient satisfaction of the intervention
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Category of risk of poor outcome (persistent disabling symptoms)
timeFrame: 3, 6, 9 and 12 months
measure: Change from baseline in Psychosocial aspects of work
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Lille
country: Belgium
facility: Lindelo
state: Antwerpen
Study officials:
affiliation: KU Leuven
name: Wim Dankaerts
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.