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CompletedNCT01129817Updated May 25, 2010

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

An interventional study of Cognitive Functional Therapy and Manual therapy and exercise in Chronic Low Back Pain, sponsored by University of Bergen. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-25.

Sponsored by University of Bergen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Low Back Pain

Keywords

  • Cognitive Functional Therapy
  • Manual Therapy and Exercise
  • Chronic Low Back Pain
  • Randomized Controlled Trial
  • Subclassification
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 121 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University of Bergen is the lead sponsor of 141 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    Cognitive Functional Therapy

    Other: Cognitive Functional Therapy

  • Active comparator
    Manual Therapy and Exercise

    Other: Manual therapy and exercise

Interventions

  • OtherCognitive 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.

  • OtherManual 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.

06

What researchers measure

Primary outcomes

  1. Pain

    Pain was assessed using a pain numerical rating scale from 0 to 10

    Time frame: 12 months

  2. Disability

    Disability measured by Oswestry Disability Index.

    Time frame: 12 months

Secondary outcomes

  1. Well being

    Hopkins Symptoms Checklist.

    Time frame: 12 months

  2. Beliefs

    Fear Avoidance Beliefs Questionnaire

    Time frame: 12 months

  3. Screening questionnaire

    The Ørebro Pain Screening Questionnaire

    Time frame: 12 months

  4. Patient satisfaction

    patient satisfaction. 5 items scale

    Time frame: 12 months

07

Study locations

1 site
  • University of Bergen
    Bergen, Hordaland 5018, Norway
08

References and documents

Publications

  • 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. PubMed 30974479 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01129817
Lead sponsor
University of Bergen
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
First posted
May 25, 2010
Start date
Mar 2006
Primary completion
Nov 2009
Completion
Nov 2009
Last update
May 25, 2010

Study contacts

Kjartan Vibe Fersum, PhD Student
principal investigator · University of Bergen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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