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

May 20, 2010
May 24, 2010
March 2006
November 2009   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01129817 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Low Back Pain
  • 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.
  • 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.
  • Experimental: Cognitive Functional Therapy
    Intervention: Other: Cognitive Functional Therapy
  • Active Comparator: Manual Therapy and Exercise
    Intervention: Other: Manual therapy and exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01129817
250.05.
Yes
Kjartan Vibe Fersum, University of Bergen
University of Bergen
Norwegian Fund for Postgraduate Training in Physiotherapy
Principal Investigator: Kjartan Vibe Fersum, PhD Student University of Bergen
University of Bergen
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP