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Clinical Trials/NCT03952741
NCT03952741CompletedNot Applicable

Cognitive Functional Therapy (CFT) Compared to Cognitive Patient Education and Physiotherapy (COPE-PT) for Patients With Non-specific Chronic Low Back Pain (NSCLBP)

University of Bergen2 sites in 1 country104 target enrollmentStarted: March 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
104
Locations
2
Primary Endpoint
Sick listing - self reported

Study Overview

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.

Detailed Description

Musculoskeletal complaints: Function, activity and work

  1. Introduction and relevance

Causes of sick-leave are multidimensional, and even if a sick-listed person has physical pain and/or functional problems, treatment models that focus only on these aspects are often not successful. In fact a sole focus on physical impairment may even medicalize the problem and increase a person's dependency on care professionals. Current knowledge suggests it is necessary to combine cognitive, functional and organizational strategies which include the workplace leader in order to reduce sick-leave absence. High quality clinical studies set in a Norwegian workplace that take all these aspects into consideration are scarce, and there is a need for research in which multiple dimensions are integrated in the management of persons who are, or are about to become sick-listed.

Musculoskeletal complaints and particularly non-specific low back pain (NSLBP) is a common reason for sick-leave in Norway. Risk profiling and stratification of workers with NSLBP is central in this project. Differences in functional capacity and requirements, particularly at work and in activities of daily living, means that workers with similar medical diagnoses may need different treatments. This research project proposes a several stages process. In the first stage, those workers who become sick-listed, or who are on the brink of becoming so, due to musculoskeletal complaints, including NSLBP, will be closely supported by specially trained workplace leaders with a focus on preventing medicalization of the problem and promoting activity. It is a legal responsibility for every workplace in Norway to take care of workers with health problems, but this has in many work-places not been optimized. In the next stage those who have musculoskeletal complaints will be invited to undergo a functional evaluation 4 weeks after their first day of sick-leave or start of their complaint. This functional evaluation can be used in the communication between the patient, their work leader and/or their primary health caretaker. Those with LBP will be invited to test an intervention model that builds on recent knowledge about sub-classification of NSLBP to reduce sick-leave, improve function and coping. This treatment is called cognitive functional therapy (CFT), will be tested in a randomized, controlled trial (RCT). There will be a comparison group in the RCT who will get a series with cognitive patient education and physiotherapy (COPE-PT) by specially trained physiotherapists. All participants will be followed by their work leaders. To enhance understanding about the causes and mechanisms of sick-leave, and to understand workers experience of treatments as well as the work leaders experience of the educational courses and their use of the functional evaluation, a parallel qualitative process evaluation will take place. The project intends to increase our knowledge of risk factors for sickness absence and how to improve the communication between the patient, their workplace and caretakers.

2 Stratification of back pain has received increased attention the last few years. There is increasing evidence that interventions based on a multidimensional understanding of patients with back- and pelvic related problems allowing more targeted intervention and can have implications for the treatment effect (Main & Watson 1996; O'Sullivan 1997; Linton 2000; Skouen et al. 2002; Fritz et al. 2003; Fersum et al. 2009). It is important that the multidimensional intervention takes place within a bio-psycho-social perspective, enabling targeted intervention towards the underlying mechanisms of pain and disability.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 67 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Cognitive Functional Therapy

Experimental

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.

Intervention: Physical Therapy (Behavioral)

Cognitive Patient Education and PT

Active Comparator

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

Intervention: Physical Therapy (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Roland Morris(Baseline, 3 months and 12 months)
  • Hopkins Symptoms Checklist(Baseline, 3 months and 12 months)
  • Numerical Pain Rating Scale (NPRS)(Baseline, 3 months and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kjartan Vibe Fersum

Associate Professor

University of Bergen

Study Sites (2)

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