search
Back to results

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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive Functional Therapy
Manual therapy and exercise
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Cognitive Functional Therapy, Manual Therapy and Exercise, Chronic Low Back Pain, Randomized Controlled Trial, Subclassification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Functional Therapy

Manual Therapy and Exercise

Arm Description

Outcomes

Primary Outcome Measures

Pain
Pain was assessed using a pain numerical rating scale from 0 to 10
Disability
Disability measured by Oswestry Disability Index.

Secondary Outcome Measures

Well being
Hopkins Symptoms Checklist.
Beliefs
Fear Avoidance Beliefs Questionnaire
Screening questionnaire
The Ørebro Pain Screening Questionnaire
Patient satisfaction
patient satisfaction. 5 items scale

Full Information

First Posted
May 20, 2010
Last Updated
May 24, 2010
Sponsor
University of Bergen
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
search

1. Study Identification

Unique Protocol Identification Number
NCT01129817
Brief Title
Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain
Official Title
Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bergen
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Cognitive Functional Therapy, Manual Therapy and Exercise, Chronic Low Back Pain, Randomized Controlled Trial, Subclassification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Functional Therapy
Arm Type
Experimental
Arm Title
Manual Therapy and Exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Cognitive Functional Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy and exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Pain was assessed using a pain numerical rating scale from 0 to 10
Time Frame
12 months
Title
Disability
Description
Disability measured by Oswestry Disability Index.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Well being
Description
Hopkins Symptoms Checklist.
Time Frame
12 months
Title
Beliefs
Description
Fear Avoidance Beliefs Questionnaire
Time Frame
12 months
Title
Screening questionnaire
Description
The Ørebro Pain Screening Questionnaire
Time Frame
12 months
Title
Patient satisfaction
Description
patient satisfaction. 5 items scale
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjartan Vibe Fersum, PhD Student
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5018
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
30974479
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs