Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain
|ClinicalTrials.gov Identifier: NCT01129817|
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : May 25, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Other: Cognitive Functional Therapy Other: Manual therapy and exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
|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.
- Pain [ Time Frame: 12 months ]Pain was assessed using a pain numerical rating scale from 0 to 10
- Disability [ Time Frame: 12 months ]Disability measured by Oswestry Disability Index.
- Well being [ Time Frame: 12 months ]Hopkins Symptoms Checklist.
- Beliefs [ Time Frame: 12 months ]Fear Avoidance Beliefs Questionnaire
- Screening questionnaire [ Time Frame: 12 months ]The Ørebro Pain Screening Questionnaire
- Patient satisfaction [ Time Frame: 12 months ]patient satisfaction. 5 items scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129817
|University of Bergen|
|Bergen, Hordaland, Norway, 5018|
|Principal Investigator:||Kjartan Vibe Fersum, PhD Student||University of Bergen|