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Cognitive Functional Therapy Compared to Cognitive Patient Education and Physiotherapy for Patients With Low Back Pain (FAktA)

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ClinicalTrials.gov Identifier: NCT03952741
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kjartan Vibe Fersum, University of Bergen

Brief Summary:

Background: There is a need for projects that link work closer to the rehabilitation chain to further understand risk factors for sick-leave. The new aspect of this project is that it combines work place intervention with individualized physiotherapy, based on validated standardized tests and a classification based treatment system.

Aim: The aim is to expand the knowledge and understanding of complex causes of musculoskeletal pain, particularly low back pain (LBP). The main aim is to examine if cognitive functional therapy (CFT) can further reduce sick-leave and pain, and increase function and well-being.

Material and methods: To ensure good recruitment we have collaboration with the Department for Health and social services in the county of Bergen, which has a sickness absence above average among their health workers.

We will invite those with LBP problems to be included in an RCT and receive CFT in a physiotherapy clinic (usually offered 5 to 12 visits). The comparison group will receive a series with cognitive patient education and physiotherapy (COPE-PT) given by a physiotherapist. All participants will be followed by their workplace leaders. All patients who enter the RCT will be re-examined at 3 and 12 months and the predictors for sick-leave, function and coping in different sub-groups of patients with NSLBP will be studied.


Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Physical Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Functional Therapy (CFT) Compared to Cognitive Patient Education and Physiotherapy (COPE-PT) for Patients With Non-specific Chronic Low Back Pain (NSCLBP)
Study Start Date : March 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Cognitive Functional Therapy
The intervention is a targeted cognitive functional therapy and will be based on examination findings. It is behaviorally directed with a focus on normalizing mal-adaptive pain, cognitive and movement behaviors in a graduated manner. In the evaluation process it is considered whether the patient has adjusted to the back complaints in a positive way (confrontation, active coping, minimal avoidance behavior) or in a negative way (passive coping, fear and avoidance behavior). Work related issues will be a particular focus, with the aim of achieving close co-operation between the worker, the workplace and the worker's responsible health care provider.
Behavioral: Physical Therapy
Other Name: Cognitive functional therapy and Cognitive patient education

Active Comparator: Cognitive Patient Education and PT
The intervention in the second group will receive much training in cognitive coping techniques after the COPE LBP trial principles (Werner et al. 2010). The educational part of the COPE for new instructors with a PT background takes 2 days supervised by Werner and his group, with regular follow-up meeting with the project leaders, together with a psychologist trained in cognitive therapy
Behavioral: Physical Therapy
Other Name: Cognitive functional therapy and Cognitive patient education




Primary Outcome Measures :
  1. Sick listing - self reported [ Time Frame: Baseline, after 3 months and after 12 months ]
    Measure if there is a change in self reported sick listing from baseline to after treatment and 12 months follow up


Secondary Outcome Measures :
  1. Roland Morris [ Time Frame: Baseline, 3 months and 12 months ]
    self-administered questionnaire with 24 statements about health status, with a score of 0-24, with 0 corresponding to no disability. It has been designed to be completed by patients to assess physical disability due to LBP

  2. Numerical Pain Rating Scale (NPRS) [ Time Frame: Baseline, 3 months and 12 months ]
    Pain intensity in the previous week was the first primary outcome, measured by The NPRS measures pain severity by asking the patient to select a number (from 0 to 10) to represent how severe the pain had been over the last 2 weeks

  3. Hopkins Symptoms Checklist [ Time Frame: Baseline, 3 months and 12 months ]
    A self reported measure of well being. Measure if there is a change in self reported well being from baseline to after treatment and 12 months follow up



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NSLBP for > 3 months, and reported that their pain was provoked by postures, movement and daily activities.
  • Pain intensity measured with a numerical rating scale (NPRS) over the last 14 days >3/10
  • Roland Morris Disability Questionnaire (RMDQ) ≥ 7 was necessary to be admitted to the study.
  • Ørebro Musculoskeletal Pain Questionnaire-short form (ØMPQ-SF) was used to examine the participants risk profile pre-treatment, and had to be ≥ 30, on a scale from 0-100.

Exclusion Criteria:

  • Continuous sick-leave duration ≥ 4 months
  • Acute exacerbation of LBP a
  • Specific LBP diagnosis - radicular pain, disc herniation, spondylolisthesis, stenosis, Modic changes
  • Any low limb surgery in the last 3 months; surgery involving the lumbar spine;
  • Pregnancy
  • Diagnosed psychiatric disorder
  • Active rheumatologic disease, progressive neurological disease
  • Serious cardiac or other internal medical condition
  • Malignant diseases, acute traumas, infections, or acute vascular catastrophes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952741


Locations
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Norway
University of Bergen
Bergen, Hordaland, Norway, 5018
Sponsors and Collaborators
University of Bergen

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Responsible Party: Kjartan Vibe Fersum, Associate Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT03952741     History of Changes
Other Study ID Numbers: 250.05
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms