Cognitive Functional Therapy Compared to Cognitive Patient Education and Physiotherapy for Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.

      Cognitive patient education (COPE) for patients with musculoskeletal pain problems, including
      LBP, has for the last few years become an element, either alone or as part of
      multidisciplinary pain programs (Moseley et al. 2004; Werner et al 2010).

      3. Methods and material

      This study is a RCT for patients with NSLBP. Those with remaining LBP complaints at this
      stage will be randomized to either targeted cognitive functional therapy (CFT) intervention
      taking place in a physiotherapy clinic or to a comparison group with cognitive patient
      education and physiotherapy (COPE-PT). All will be followed by their workplace leader at
      their individual workplace.

      Research questions:

      RCT study: Persons with 4-8 weeks of sick-leave and/or who has remaining NSLBP at this stage:
      Do workers receiving cognitive functional therapy (CFT) combined with workplace intervention,
      have reduced sick-leave, improved function and coping, compared to those receiving cognitive
      patient education and physiotherapy (COPE-PT), in combination with workplace intervention, at
      3 and 12 months after the intervention?

      Material, design and outcome measures

      Study

      Cognitive functional therapy (CFT) compared to cognitive patient education and physiotherapy
      (COPE-PT) for patients with non-specific chronic low back pain (NSCLBP):

      Participants with NSCLBP will be recruited as part of another study related to the FAkta
      project. Before randomization all patients will be examined with standardized tests as well
      as with a short walking test with the use of an accelerometer.

      Workers with NSLBP will be randomized to either CFT (O'Sullivan, 2000, 2005) or to a
      comparison group with COPE-PT. All participants will be followed by their workplace leaders.
      Persons who randomly are allocated to either the CFT intervention group or comparison group
      COPE-PT will be offered treatment by specially trained physiotherapists at a physiotherapy
      clinic, based on the multidimensional understanding of their complaints.

      Outcome measures: The primary outcome measure in the RCT is sick-leave, measured by number of
      days absence from work. The participants in this study will, in addition to the
      questionnaires mentioned above, have the the Roland Morris questionnaire as secondary outcome
      measure. The project will start at the beginning of 2012, and persons will be included until
      the end of 2013, with the last follow-up at the end of 2014.

      Power calculation: In a former study (Steenstra et al. 2006) where a similar model for
      workplace intervention was evaluated, an average of 100 days (SD=96.0) of sick-leave was
      found for back patients who received intervention, compared to 130 days (SD=70.0) in those
      who received treatment-as-usual. A sample size of 123 participants in each group gives a
      power of 80 % to detect an effect of this magnitude with significance level at 0.05.

      However, a recent power calculation based on the recent results from Fersum et al. (2013)
      where CFT was compared to manual therapy indicate that it should be sufficient with 30
      participants in each group. The results have still not been published internationally, but
      measured in effect size (ES), the difference between the new CFT compared to today's usual
      practice with manual therapy and exercise was around 1 ES on most measures, in favor of the
      CB-CFT, reflecting both a statistical and clinical significant difference. The participant in
      this new study will, however, probably have more problems compared to the previous RCT. This
      has enabled us to aim for intervention group and one comparison group with at least 50, but
      hopefully close to 70 in each group. This sample size will give adequate power to detect
      sick-leave differences of this magnitude, even allowing for a substantial attrition rate.

      Personal resources in the study : All PTs that will take part in study will receive an
      instructional course covering subjects like work life, optimal cognitive approach for the
      patients, and strategies to ensure optimal co-operation between the workplace and the worker.
      Three of these experienced therapists will have specialized training in the CFT intervention,
      which they have already utilized in participation in a similar, recent RCT. The 4-5 PTs in
      the second intervention group will not be familiar with CFT, but they will receive much
      training in cognitive coping techniques after the COPE-PT LBP trial principles (Werner et al.
      2010). The educational part of the COPE-PT 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 (Minna Hynninen).

      The CFT is adjusted to the individual, with minimum duration of 45 minutes each session, and
      4 - 8 treatments during a period of 8 - 12 weeks (average 7-8 treatments). Follow-up will
      take place after the intervention period (at 3 months) and will include a physical
      examination and questionnaires. The next follow-up will be at 12 months and by questionnaires
      only. The participants in COPE-PT will receive one weekly session 4 times, and the follow-up
      examination will also be at 3 and 12 months, similar to the CFT group.

      The person in charge of the RCT is researcher Kjartan Vibe Fersum, who will assist in the
      project co-ordination and CFT treatment. Alice Kvåle will together with the research fellow
      Tove Ask be an assessor of all patients who enter the project at 4-6 weeks. Only Kvåle will
      do the re-examination at 3 months of patients who have entered the RCT and she will be
      blinded for group belonging.

      4. Organization, budget and relevance

      Project management, organisation and cooperation The Physiotherapy research group, unit for
      Musculoskeletal complaints, at the Department of Public Health and Primary Health Care,
      University of Bergen (UiB) is responsible for managing and organizing the project, in
      cooperation with the Department of Health- and Social Services at Bergen County. This
      department has documented above average sick-leave among their health service employees, and
      both the management and the political leaders of the department aim to reduce this.

      Budget This project has got Nkr. 4.700.000,- from the Norwegian Fund for Postgraduate
      Training in Physiotherapy to cover expenses for Kjartan Vibe Fersum and Tove Ask in the time
      period 2011 to 2015. Other resources are either part of our research positions at UiB or have
      been/will be applied for. Details are found in Appendix IV. The Department of Health and
      Social Services at Bergen County has agreed to let the workplace leaders and union leaders
      have paid leave when participating in the education courses and/or in the focus group
      interviews.

      Compliance with strategic documents At the Department of Public Health and Primary Health
      Care, UiB, we have many resource persons who have musculoskeletal pain as their major area of
      interest, which is reflected both in the departments' research and teaching. One major goal
      is to further enhance knowledge and understanding regarding the complex causes and mechanisms
      of musculoskeletal pain and disability, as well as to examine the effect of a targeted
      functional approach in combination with focus on the workplace, evaluated both on the
      individual and the societal level. Part of this project aims to identify subgroups of workers
      with non-specific low back pain who just have been sick-listed or who are about to be so.
      This allows workers to be classified in such a way that they will respond to targeted
      treatment and get substantial improved effect of the intervention in comparison to what is
      usual today. The project will be performed in close co-operation with the Department of
      Health and Social Services, Bergen County.

      Relevance to society In a recent reform for interaction between the municipalities and
      secondary health services in Norway ("Samhandlingsreformen" 2010), the importance of
      increased focus on health promotion and rehabilitation within the local councils has been
      underlined. A more efficient system of management and treatment within the primary health
      care system should prevent more extensive and chronic complaints. Recognition of the early
      signs and risk factors of musculoskeletal complaints in a bio-psycho-social perspective in
      different subgroups of workers is of great importance. Health promotion and rehabilitative
      measures must recognize the different needs of different groups ("Rett behandling, på rett
      sted, til rett tid" - Jfr. St.m.47). Effective communication between the worker, the
      workplace and the treating PTs/MTs in the municipality are central. The workers who are
      recruited to the project are themselves all workers within the Department of Health and
      Social Services. Their work is often quite physically demanding, and they have an above
      average percentage of sick-leave. It is challenging to try to improve function in workers
      with heavy workloads in order to reduce sick-leave, for the benefit of the individual and for
      society.

      The project is likely to have important consequences regarding how workers at risk are cared
      for in the workplace, potentially highlighting the need for the right actions to the right
      time. The results of this study may lead to better interaction between health personnel (here
      mainly PTs/MTs), the work place and the occupational health services. The RCT will clarify
      whether classification based CFT results in greater improvements in function and working
      ability, than treatment-as-usual. The qualitative part of the project will give insight into
      the mechanisms for sick-leave, and give additional information as far as aspects that can be
      improved in to enhance workplaces effectiveness in dealing with musculoskeletal complaints,
      especially with reference to workers with back problems.

      Environmental perspectives By means of the RCT the aim is to test if the new treatment model
      of CFT combined with focus on the workplace, will lead to improved function and less sickness
      absence, in comparison to a cognitive treatment strategy without hands-on.

      5. Ethics

      Ethical aspects There is no harm related to participation in the project. The participants
      will get written and verbal information about the project via their workplace leader (head
      nurse/department leader). Pamphlets will also be distributed with information at the
      different workplaces. Interested participants with musculoskeletal complaints will then
      directly book an appointment. An informed consent will be made separately for Study II, and a
      new one for Study III and IV. According to current rules and regulations regarding
      responsibility for employees, each work place should maintain regular contact with
      sick-listed workers and try to include them at work ("Avtale om Inkluderende arbeidsliv").
      The additional part will be to fill in questionnaires and agree to a physical examination 4-6
      weeks later. Participants will, when included into the RCT in Study III, be asked if they
      want to take part in the focus group interviews in Study IV. An application for the complete
      project will be sent to Regional Ethical Committee.

      Gender equality and gender perspectives More women than men are working in health care and
      have a higher percentage of sick-leave, although both gender will be invited to participate.
      The project will focus on identifying mechanisms for sick-leave absence in a
      bio-psycho-social perspective, and the gender perspective, both organizational and physical,
      will be focused on.

      6. Communication with users and utilization of results

      Communication with users Central users in this project are health workers in the primary
      health care system and representatives from them have been involved in planning of the
      project and will continue to be so. The research results will be mediated in meetings with
      the work group leaders and head nurses and in courses arranged for the employees. The
      workplace leaders will meet the research team and the appointed course instructors to
      exchange experience several times throughout the project period.

      Dissemination plan The research material will be analyzed and disseminated in articles
      published in relevant, national and international referee based journals. Furthermore,
      information will be disseminated by courses and lectures to health workers employed in
      primary health care facilities, as well as to physiotherapists/manual therapists working in
      physiotherapy clinics, based on the results of the different studies. It is anticipated that
      the workplace contacts will continue for workers at risk for becoming sick-listed also after
      the project has ended, if the study has shown positive results.
    

Intervention name(s): Physical Therapy
Intervention type(s): Behavioral
Other intervention name(s): Cognitive functional therapy and Cognitive patient education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment