Clinical trial NCT01129817: Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain
Official title: Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Cognitive Functional Therapy
Manual Therapy and Exercise
Chronic Low Back Pain
Randomized Controlled Trial
Subclassification
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2010-05-25
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 12 months
measure: Disability
timeFrame: 12 months
Secondary outcomes:
measure: Well being
timeFrame: 12 months
measure: Beliefs
timeFrame: 12 months
measure: Screening questionnaire
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Kjartan Vibe Fersum, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vibe Fersum K, Smith A, Kvale A, Skouen JS, O'Sullivan P. Cognitive functional therapy in patients with non-specific chronic low back pain-a randomized controlled trial 3-year follow-up. Eur J Pain. 2019 Sep;23(8):1416-1424. doi: 10.1002/ejp.1399. Epub 2019 May 14.