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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01882686
Enrollment
41
Registered
2013-06-20
Start date
2012-12-31
Completion date
2016-03-31
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

Pain, Back Pain, Low Back Pain, Chronic Low Back Pain, Cognitive Functional Therapy, Intervention, Subclassification, Multidimensional

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.

Interventions

OTHERClassification 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.

Sponsors

European Social Fund
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in pain3, 6, 9 and 12 monthsPain was assessed using a numerical pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Change from baseline in disability3, 6, 9 months, 1 and 3 yearDisability was measured using the Oswestry Disability Index (ODI)

Secondary

MeasureTime frameDescription
Change from baseline in Chance of long-term disability and failure to return to work3, 6, 9 and 12 monthsTha 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.
Change from baseline in Physical activity3, 6, 9 and 12 monthsBaecke questionnaire
Change from baseline in Sleep problems3, 6, 9 and 12 monthsInsomnia Severity Index (ISI)
Change from baseline in Depression, anxiety and stress3, 6, 9 and 12 monthsDepression Anxiety and Stress scale (DASS-21)
Change from baseline in Self-efficacy, coping3, 6, 9 and 12 monthsPain Self-Efficacy Questionnaire (PSEQ)
Change from baseline in Pain catastrophizing3, 6, 9 and 12 monthsPain Catastrophizing Scale (PCS)
Change from baseline in Psychosocial job aspects3, 6, 9 and 12 monthsThe Job Content Questionnaire (JCQ) is a tool for psychosocial job assessment.
Change from baseline in Lower Lumbar spine Kinematics3, 6, 9 and 12 monthsLower Lumbar kinematics of the spine were measured with the BodyGuard (sels-instruments nv). This is a remote measuring system.
Patient satisfaction of the intervention3, 6, 9 and 12 monthsPatients' Global Impression of Change (PGIC) scale
Change from baseline in Category of risk of poor outcome (persistent disabling symptoms)3, 6, 9 and 12 monthsThe 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.
Change from baseline in Psychosocial aspects of work3, 6, 9 and 12 monthsPsychosocial Aspects of Work Questionnaire (PAWQ)
Change from baseline in Fear-avoidance / kinesiophobia3, 6, 9 and 12 monthsTampa Scale of Kinesiophobia (TSK-17)
Change from baseline in Beliefs about LBP3, 6, 9 and 12 monthsBack Beliefs Questionnaire (BBQ)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026