Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00840697 |
| Other study ID # |
return to work and exercise |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
February 9, 2009 |
| Last updated |
June 24, 2011 |
| Start date |
August 2009 |
| Est. completion date |
August 2013 |
Study information
| Verified date |
May 2011 |
| Source |
Oslo University Hospital |
| Contact |
Anne Keller, Dr.med.Sc |
| Phone |
+4723026451 |
| Email |
anne.keller[@]medisin.uio.no |
| Is FDA regulated |
No |
| Health authority |
Norway: Data Protection Authority |
| Study type |
Interventional
|
Clinical Trial Summary
Low back pain is a usual condition in the western countries and several treatments available
for patients with "non-specific low back pain". According to the European guidelines both
Brief intervention and exercise/cognitive intervention are effective treatments with regard
to pain and function (www.backpaineurope.org), but none have documented effect on return to
work.
The challenges for health personnel is not cure of the patients back pain, but to build up
rehabilitation programs which focus on disability and work incapacity, in patients which are
at risk of loosing their work. Dr. P. Loisel, Montreal, Canada", has since 1995 treated
patients with back pain according to the "The PREVICAP model - (PREVention of work
handICAP)", where the main purpose with work-related program is to prevent prolonged
disability and to help patients back to work. Loisel demonstrated that the PREVICAP models
accelerated the "return to work" factor by a factor 2.4 (p=0.01). The PREVICAP model had
also been evaluated in Amsterdam, by Dr. Anema with the same results.
At the Back Clinic, Ullevål University Hospital we are presently involved in a randomized
controlled trial after the PREVICAP model, where patients are randomized to Brief
intervention including a work-related intervention or usual care. All included patients in
both groups, will have a clinical examination by specialist in Physical Medicine and
Rehabilitation and advice from a physiotherapist. The current study replaces Brief
intervention with an exercise - and a work-related program, so patients with non-specific
LBP will be randomized to an exercise and work-related program or usual care.
The main purpose of this study
- to investigate if rehabilitation programs specifically focusing on the return to work
process will reduce sickness absence and disability pension in patients with neck and
low back pain.
- to assess the work-, individual- and health factors and their interrelationship
predicting sickness absence and work disability.
- to compare results from the rehabilitation program with results from rehabilitation
program in Toronto
- to which extent are the patients met by actions from employers and employment services,
and does is influence sickness absence and disability.
- do these actions represent favourable cost benefit for the work places and the society
Description:
Background:
Norway has the highest sickness absence of the Scandinavian countries, with a cost of about
40 milliard kr each year. In addition about 500 000 receive rehabilitation or disability
pension comprising a cost of 75 milliard kr. Musculoskeletal pain is the most common cause
of sickness absence and among the 3 most common causes of disability pension in Norway [1].
For young subjects (<40 years) musculoskeletal disorders also represent the most common
cause for disability pension [2]. Neck and low back pain comprise the majority of patients
with musculoskeletal disorders. Hence, several actions have been initiated in order to
reduce sickness absence and improve participation in the working life.
The agreement about "including work life" ("IA avtalen") was introduced in 2001, and
represented a joint effort from the government, the employers' organizations and the labor
organizations. The superior aim was to prevent sickness absence and promote the inclusion in
the working life despite sickness and disability. However, it soon became clear that there
was a contradiction between the goals of reducing sickness absence and including subjects
with diseases and disabilities. In addition it became clear that the knowledge about the
factors facilitating participation in working life was scarce. Groups with low education
level, foreign origin, women and subjects with chronic diseases dominating the sickness
absence statistics were not reached [3], and effective strategies to improve also these
groups employment were sought. Hence, a committee leaded by the prime minister granted above
600 mill kr in order to reduce the sickness absence about 2.5 %. The committee recognized
the need of reinforcing the collaboration between the employers and the employed. However,
the main focus the need of a coordinated effort from the health care system and the social
security and employment service. The latter two are fused to one organisation in Norway
termed "NAV" (Nye arbeids og velferds etaten). Necessary health services need to be provided
immediately and a close collaboration with the social security and employment service as
well as the employers.
Most of the patients with neck and low back pain have benign and self-limited conditions,
which they nevertheless experience as pain full and disabling [4;5]. According to the
European guidelines, exercise and cognitive intervention has good effects on pain and
function for patients with low back pain [6] (www.backpaineurope.org). Multimodal treatment
including exercises has also been shown effective for patients with neck pain [7]. However,
these treatment modalities do not seem sufficiently effective in order to improve return to
work [8].
Neck and low back pain is a multifactorial problem, which is not only due to workers'
medical characteristics, but is also closely related to environmental factors, such as the
workplace and individual factors. Physical factors like heavy lifting, vibration and posture
demands may be of importance for low back pain [9;10]. The working life of today demanding
increasingly use of computers is a risk factor for neck, shoulder and arm disorders.
Particularly, where the work station is poorly designed and the duration of the computer use
above 4 hours a day there is a risk for pain development [10]. Even more important is the
psychosocial environment at work. Factors such as control over the work situation, demands
and support from the colleagues and leader are of importance [11]. The compensation system
and the interaction between all stakeholders in the disability problem and the health care
system are of importance for the return to work [12;13]. In addition time is a significant
factor, with reduced return to work after longer periods of sick leave [14]. Among the
individual factors of major importance is educational level [15], which of course is related
to socioeconomic class. Age, gender and cultural background are also well known predictors
for sickness absence and disability pension [16], which adds to the higher prevalence of
musculoskeletal pain in these groups [17]. Interventions at the work place coordinated with
early contact with worker by workplace, contact between healthcare provider and workplace
has also been shown to improve return to work [18].
Thus, return to work is not dependent on one single step, but a challenging process where
the patient, health professionals, employers and employment system must interact. A
particular challenge is to build up rehabilitation-programs for patients at risk of loosing
their work [19]. Dr. P. Loisel, Montreal, Canada" [20], have since 1995 treated patients
with low back pain according to the "The PREVICAP modell - (PREVention of work handICAP)".
The main purpose with work-related program is to prevent prolonged disability and helping
patients to return to work. This process includes identification of factors on the workplace
which contribute to the absence of work. These factors include physical, ergonomic,
psychosocial, interpersonal conflicts and administrative problems. Subsequently "workplace
intervention" is initiated. This is a rehabilitation-program centered at the workplace,
allowing a graded transition from the clinical setting to the workplace. Parallel with the
workplace intervention the patients enter into a short exercise-program, adjusted to the
workplace intervention. The Previcap models have been evaluated in randomized controlled
trials and accelerated the return to work by a factor 2.4 and the most important effect came
from the workplace intervention, which accelerated the return to work with a factor 1.9.
Patients randomized to the Previcap model had 60 days absence from work, compared to 120
days in the control group [20;21]. The Previcap-model have also been evaluated in Amsterdam,
by Dr. Anema and he demonstrated a significant difference in the return to work rate between
patients randomized to "Workplace intervention" and to usual treatment. This type of
interventions has not been tried on patients with neck pain, and in general the knowledge
regarding neck pain is poorer than for low back pain. Hence, Sconstein et al [8] performing
a Cochrane review, concluded that there is an urgent need for well designed randomised
studies trying to facilitate return to work in patients with neck pain.
It is also important to take into account that the predictors for sickness absence are
different from the factors determining return to work [22]. This is largely embezzled in the
intervention strategies. Another shortcoming is failure to meet the needs of the employees
with disabilities [23]. That may be chronic back conditions that cannot be cured, or the
combined cause of back pain and comorbidity which is frequent in this population [24]. This
is particularly important as employment seems to be a very important factor for mental
health in subjects with disabilities [25]. Research focusing on the interrelationship
between these different factors is lacking. This type of knowledge is needed in order to
improve the intervention strategies. It is also obvious that success can only be achieved if
the employment services and stakeholders contribute. Hence, the research in this field calls
for a joint effort between the health care services, employers and employment services.
At Ulleval University Hospital (UUH) and at St Olavs hospital the health care for patients
with neck-and back pain has been organised in multi-professional units, taking care of a
about 4000 and 2000? patients, respectively, at an annual basis. Within this system it is
possible to provide necessary diagnostic evaluation and medical treatment. The ongoing NAV
projects at both institutions provide the possibility to offer medical care within 2 weeks.
Multimodal treatments including exercises are also provided. At UUS, the PREVICAP model is
implemented and evaluated against usual treatment for patients with low back pain in a
randomized trial. However, patients with neck pain are not included. Hence, a main intention
is to evaluate the PREVICAP model in a randomized trial including patients with neck pain.
In a worker population the psychosocial factors at work including relationship between
demand and control [26] as well as the balance between effort and rewards [27] are shown to
be of importance. Such a comprehensive assessment of patient reported work-related factors
has not previously been performed in the specialized health care. These factors will be
combined with the medical assessment and personal factors in the multiple prediction models,
in order to single out combinations of factors of importance.
Although, The PREVICAP model had shown good results on Return to work, in Montreal, and
Amsterdam, it is unknown how this model will work out in other countries, due to differences
in culture, working terms and compensatory system? So, we will collaborate with the research
group in Toronto (D.Cassidy, Health Network Rehabilitation Solutions,Toronto Western
Hospital) to up multinational studies for Return to work-Rehabilitation for patients with
neck and back complaints.
The process of returning to work can only be completed when the identified problems can be
met with adequate actions at the work place and NAV. These actions also reduce costs
associated with work disability duration [18;28]. Few studies have addressed how the
collaboration between the health care system and both employers and employment services.
Hence, to which extent the advised adaptations at the work place are taken care of as well
as the support given by NAV need to be assessed and related to the outcome of participation
in working life. And at last, the costs and potential socioeconomic consequences of these
actions need to be assessed.
The main purpose of this study is to combine the knowledge of the medical aspect of neck-and
back pain with the knowledge of organizational and compensatory structure, occupational- and
socioeconomic factors for investigating these factors influence and cause of the phenomenon
sick-leave.
The specific aims are:
- to assess the work-, individual- and health factors and their interrelationship
predicting sickness absence and work disability.
- to investigate if rehabilitation programs specifically focusing on the return to work
process will reduce sickness absence and disability pension in patients with neck and
low back pain.
- to compare results from the rehabilitation program with results from rehabilitations
program in Toronto
- to which extent are the patients met by actions from employers and employment services,
and does is influence sickness absence and disability.
- do these actions represent favorable cost benefit for the work places and the society
