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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129817
• Other study ID #: 250.05.
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: May 24, 2010
• Start date: March 2006
• Est. completion date: November 2009

Study information

• Verified date: May 2010
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen	Hordaland

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain was assessed using a pain numerical rating scale from 0 to 10	12 months	No
Primary	Disability	Disability measured by Oswestry Disability Index.	12 months	No
Secondary	Well being	Hopkins Symptoms Checklist.	12 months	No
Secondary	Beliefs	Fear Avoidance Beliefs Questionnaire	12 months	No
Secondary	Screening questionnaire	The Ørebro Pain Screening Questionnaire	12 months	No
Secondary	Patient satisfaction	patient satisfaction. 5 items scale	12 months	No