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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Cognitive Functional Therapy; Other: Manual therapy and exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5018
      • University of Bergen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain was assessed using a pain numerical rating scale from 0 to 10	12 months
Disability	Disability measured by Oswestry Disability Index.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well being	Hopkins Symptoms Checklist.	12 months
Beliefs	Fear Avoidance Beliefs Questionnaire	12 months
Screening questionnaire	The Ørebro Pain Screening Questionnaire	12 months
Patient satisfaction	patient satisfaction. 5 items scale	12 months

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: Norwegian Fund for Postgraduate Training in Physiotherapy
• Investigators: Principal Investigator: Kjartan Vibe Fersum, PhD Student, University of Bergen

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 24, 2010
• First Posted (Estimate): May 25, 2010

Study Record Updates

• Last Update Posted (Estimate): May 25, 2010
• Last Update Submitted That Met QC Criteria: May 24, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Chronic Low Back Pain; Cognitive Functional Therapy; Manual Therapy and Exercise; Subclassification
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 250.05.