Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03952741 |
| Other study ID # |
250.05 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2012 |
| Est. completion date |
November 2017 |
Study information
| Verified date |
May 2019 |
| Source |
University of Bergen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
