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

Study Overview
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Classification Based Cognitive Functional Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Classification Based Cognitive Functional Therapy<br> | Other: Classification Based Cognitive Functional Therapy<br>* 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.<br>* Other names: cognitive functional therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline in disability | Disability was measured using the Oswestry Disability Index (ODI) | 3, 6, 9 months, 1 and 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Beliefs about LBP | Back Beliefs Questionnaire (BBQ) | 3, 6, 9 and 12 months | 
| 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 | 
| Change from baseline in Physical activity | Baecke questionnaire | 3, 6, 9 and 12 months | 
| Change from baseline in Sleep problems | Insomnia Severity Index (ISI) | 3, 6, 9 and 12 months | 
| Change from baseline in Depression, anxiety and stress | Depression Anxiety and Stress scale (DASS-21) | 3, 6, 9 and 12 months | 
| Change from baseline in Self-efficacy, coping | Pain Self-Efficacy Questionnaire (PSEQ) | 3, 6, 9 and 12 months | 
| Change from baseline in Fear-avoidance / kinesiophobia | Tampa Scale of Kinesiophobia (TSK-17) | 3, 6, 9 and 12 months | 
| Change from baseline in Pain catastrophizing | Pain Catastrophizing Scale (PCS) | 3, 6, 9 and 12 months | 
| 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 | 
| 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 | 
| Patient satisfaction of the intervention | Patients' Global Impression of Change (PGIC) scale | 3, 6, 9 and 12 months | 
| 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 | 
| Change from baseline in Psychosocial aspects of work | Psychosocial Aspects of Work Questionnaire (PAWQ) | 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multidimensional, Pain, Back Pain, Low Back Pain, Chronic Low Back Pain, Cognitive Functional Therapy, Intervention, Subclassification