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

Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01129817
Enrollment
121
Registered
2010-05-25
Start date
2006-03-31
Completion date
2009-11-30
Last updated
2010-05-25

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

Cognitive Functional Therapy, Manual Therapy and Exercise, Chronic Low Back Pain, Randomized Controlled Trial, Subclassification

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.

Interventions

A novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation with 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.

Patients in this group was treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and was designed to be consistent with best current manual therapy practice in Norway. The particular dose and techniques were at the discretion of the treating therapist, based on each participant's objective and physical examination findings. In addition most of the patients in this group was given exercises or a home exercise program.

Sponsors

Norwegian Fund for Postgraduate Training in Physiotherapy
CollaboratorOTHER
University of Bergen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Disability12 monthsDisability measured by Oswestry Disability Index.
Pain12 monthsPain was assessed using a pain numerical rating scale from 0 to 10

Secondary

MeasureTime frameDescription
Well being12 monthsHopkins Symptoms Checklist.
Beliefs12 monthsFear Avoidance Beliefs Questionnaire
Screening questionnaire12 monthsThe Ørebro Pain Screening Questionnaire
Patient satisfaction12 monthspatient satisfaction. 5 items scale

Countries

Norway

Outcome results

None listed

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