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

This study has been completed.
Sponsor:
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by:
University of Bergen
ClinicalTrials.gov Identifier:
NCT01129817
First received: May 20, 2010
Last updated: May 24, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
 Other: Cognitive Functional Therapy
Other: Manual therapy and exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Pain was assessed using a pain numerical rating scale from 0 to 10

  • Disability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disability measured by Oswestry Disability Index.


Secondary Outcome Measures:
  • Well being [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hopkins Symptoms Checklist.

  • Beliefs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fear Avoidance Beliefs Questionnaire

  • Screening questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The Ørebro Pain Screening Questionnaire

  • Patient satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    patient satisfaction. 5 items scale


Enrollment: 121
Study Start Date: March 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Functional Therapy Other: Cognitive Functional Therapy
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.
Active Comparator: Manual Therapy and Exercise Other: Manual therapy and exercise
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129817

Locations
Norway
University of Bergen
Bergen, Hordaland, Norway, 5018
Sponsors and Collaborators
University of Bergen
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
Principal Investigator: Kjartan Vibe Fersum, PhD Student University of Bergen
  More Information

No publications provided

Responsible Party: Kjartan Vibe Fersum, University of Bergen
ClinicalTrials.gov Identifier: NCT01129817     History of Changes
Other Study ID Numbers: 250.05.
Study First Received: May 20, 2010
Last Updated: May 24, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Bergen:
Cognitive Functional Therapy
Manual Therapy and Exercise
Chronic Low Back Pain
Randomized Controlled Trial
Subclassification

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013