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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT01129817
• Lead Sponsor: University of Bergen

Brief Summary

A randomized controlled trial of the efficacy of classification based cognitive functional physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual therapy and exercise in patients with non specific chronic low back pain.

The investigators hypothesis was that treatment targeted at the mechanism behind the problem from a multidimensional perspective would be superior to traditional treatment.

Detailed Description

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 our new understanding of NSCLBP has not resulted in clinical trials utilizing multidimensional classification systems or targeted interventions based on the underlying mechanisms. line with this shift in paradigm a novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation of. with matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-05
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-24
• Last Update Submitted: 2010-05-24
• Study First Posted: 2010-05-25
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• all patients with non-specific LBP for more that 8 weeks duration
• mechanical provocation of pain with postures, movement and activities
• localised pain in the area from T12 to gluteal folds
• moderate ongoing LBP with a VAS > 2/10
• disability had to be higher than 14% on Oswestry Disability Index

Exclusion Criteria

• sick listed for more than 4 months continuous duration
• acute exacerbation of LBP
• radicular pain with positive neural tissue provocation test
• any low limb surgery on the last 3 months
• surgery involving the lumbar spine (fusion)
• pregnancy
• psychiatric disorders - somatisation
• dominant psycho-social problems
• 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 catastrophies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability	12 months	Disability measured by Oswestry Disability Index.
Pain	12 months	Pain was assessed using a pain numerical rating scale from 0 to 10

Secondary Outcome Measures

Name	Time	Method
Well being	12 months	Hopkins Symptoms Checklist.
Beliefs	12 months	Fear Avoidance Beliefs Questionnaire
Screening questionnaire	12 months	The Ørebro Pain Screening Questionnaire
Patient satisfaction	12 months	patient satisfaction. 5 items scale

Trial Locations

Locations (1)

University of Bergen; 🇳🇴 Bergen, Hordaland, Norway