Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatment classification based cognitive functional therapy
Phase phase 2
Sponsor Katholieke Universiteit Leuven
Collaborator European Social Fund
Start date December 2012
End date March 2014
Trial size 45 participants
Trial identifier NCT01882686, S54606

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
classification based cognitive functional therapy 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.

Primary Outcomes

Measure
Change from baseline in pain
time frame: 3, 6, 9 and 12 months
Change from baseline in disability
time frame: 3, 6, 9 and 12 months

Secondary Outcomes

Measure
Change from baseline in Beliefs about LBP
time frame: 3, 6, 9 and 12 months
Change from baseline in Chance of long-term disability and failure to return to work
time frame: 3, 6, 9 and 12 months
Change from baseline in Physical activity
time frame: 3, 6, 9 and 12 months
Change from baseline in Sleep problems
time frame: 3, 6, 9 and 12 months
Change from baseline in Depression, anxiety and stress
time frame: 3, 6, 9 and 12 months
Change from baseline in Self-efficacy, coping
time frame: 3, 6, 9 and 12 months
Change from baseline in Fear-avoidance / kinesiophobia
time frame: 3, 6, 9 and 12 months
Change from baseline in Pain catastrophizing
time frame: 3, 6, 9 and 12 months
Change from baseline in Psychosocial job aspects
time frame: 3, 6, 9 and 12 months
Change from baseline in Lower Lumbar spine Kinematics
time frame: 3, 6, 9 and 12 months
Patient satisfaction of the intervention
time frame: 3, 6, 9 and 12 months
Change from baseline in Category of risk of poor outcome (persistent disabling symptoms)
time frame: 3, 6, 9 and 12 months
Change from baseline in Psychosocial aspects of work
time frame: 3, 6, 9 and 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 - moderate ongoing LBP, average pain intensity visual analogue scale (VAS) > 2/10 - 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

Additional Information

Official title Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain - a Series of Case-controls
Principal investigator Wim Dankaerts
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Katholieke Universiteit Leuven.