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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Cognitive Functional Therapy
* Other: Manual therapy and exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Functional Therapy<br> | Other: Cognitive Functional Therapy<br>* 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.<br>|
| Active Comparator: Manual Therapy and Exercise<br> | Other: Manual therapy and exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain was assessed using a pain numerical rating scale from 0 to 10 | 12 months | 
| Disability | Disability measured by Oswestry Disability Index. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well being | Hopkins Symptoms Checklist. | 12 months | 
| Beliefs | Fear Avoidance Beliefs Questionnaire | 12 months | 
| Screening questionnaire | The Ørebro Pain Screening Questionnaire | 12 months | 
| Patient satisfaction | patient satisfaction. 5 items scale | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Functional Therapy, Manual Therapy and Exercise, Chronic Low Back Pain, Randomized Controlled Trial, Subclassification