"Back on Track"; Chronic low back pain rehabilitation program in primary care

Chronic Low-back pain (CLBP) is one of the major health problems in Western
countries and has high impact on medical and societal costs. For the majority
of these cases (90%) medical specialists are not able to specifically find a
cause for low-back symptoms and are therefore called non-specific low-back
pain. Various therapeutic interventions have been developed to prevent or
reduce CLBP and the accompanying high medical and societal costs. Interventions
based on cognitive-behavioral concepts are assumed to be more effective as
compared to exercise interventions since focusing on psychosocial factors might
result in long-term effects as well. However, such interventions are primarily
offered as a multidisciplinary rehabilitation programs and are very costly.
Studies investigating whether it would be feasible and effective to substitute
a multidisciplinary cognitive based program into primary care would therefore
be of main importance. In addition, since previous studies suggested that the
amount of improvement from an intervention based on psychosocial aspects might
vary between subgroups of patients with CLBP (e.g. patients with complex
psychosocial problems will respond differentially than patients with less
psychosocial factors), it would therefore be interesting to evaluate the effect
of such interventions in specific subgroups, especially in WPN2 and WPN3 since
the contributing role of psychosocial factors in the maintenance of disability
is only low to moderate.

The first part of this project will therefore focus on the effectiveness of a
newly developed primary care intervention *Back on Track* in improving daily
life functioning in patients with CLBP who are experiencing moderate level of
disability and the contributing role to this disability of psychosocial factors
is at maximum low (WPN2-classification) as compared to regular physical therapy
based on the Dutch guideline. It is expected that the new primary care
intervention *Back on Track* will be more effective than primary care
interventions without a cognitive behavioral approach (e.g. regular physical
therapy). Subsequently it will be investigated whether the primary care
intervention *Back on Track* will be more cost-effective than primary usual
care.

In addition, patients experiencing moderate to high level of disability and in
which the contributing role of psychosocial factors to this disability is low
to moderate (WPN3- classification) are hypothesized to benefit from this new
intervention as well. Therefore, in the second part of this project it will be
evaluated whether an intervention based on a cognitive behavioral approach is
feasible and results in improved daily life functioning for this subgroup of
patients.

Primary objective
- To assess the differences in treatment effect (change of functional
disability between pre- and post-treatment, and between pre-treatment and 3
months of follow up) between the new primary care intervention *Back on Track*
and usual primary care in patients with CLBP experiencing moderate level of
disability and the contributing role to this disability of psychosocial factors
is at maximum low (WPN2).

Hypothesis: It is hypothesized that the new primary care intervention *Back on
Track* will be more effective in reducing functional disability at
post-treatment and after 3 months follow-up than a usual primary care
intervention in patients with CLBP experiencing moderate level of disability
and the contributing role to this disability of psychosocial factors is at
maximum low (WPN2).

Secondary Objectives:
- To assess the difference in cost-effectiveness and cost-utility between the
new primary care intervention *Back on Track* and usual primary care in
patients with CLBP experiencing moderate level of disability and the
contributing role to this disability of psychosocial factors is at maximum low
(WPN2).

Hypothesis: It is hypothesized that the new primary care intervention *Back on
Track* will be more cost-effective in reducing functional disability than usual
primary care in patients with CLBP experiencing moderate level of disability
and the contributing role to this disability of psychosocial factors is at
maximum low (WPN2).

- To assess whether the primary care intervention *Back on Track* improves
functional disability (QBPDS) directly after treatment and after 3 months of
follow-up in patients with CLBP experiencing moderate to high level of
disability and in which the contributing role of psychosocial factors to this
disability is low to moderate (WPN3-).

Hypothesis: It is hypothesized that the new primary care intervention *Back on
Track* will improve functional disability directly after treatment and after 3
months of follow-up in patients with CLBP experiencing moderate to high level
of disability and in which the contributing role of psychosocial factors to
this disability is low to moderate (WPN3-).

A *Back on Track* intervention study with a RCT-arm.

Patients with CLBP and classified as WPN2 and WPN3- will be recruited by
consultants in rehabilitation medicine, working at Maastricht University
Medical Center (MUMC+). Patients with a WPN2 classification will be randomized
to either the new *Back on Track* primary care intervention or primary care as
usual, both provided by physical therapists in primary care. Physiotherapy
practices are located in Maastricht and surrounding villages. Both treatment
periods will last for eight weeks maximally. Both patients and data-analysts
will be blinded throughout the study. Patients classified as WPN3- will be
informed about the study by their consultant in rehabilitation medicine and
will be free to choose between the new intervention *Back on Track* and regular
multidisciplinary pain rehabilitation care. Participation would automatically
mean that they would receive the *Back on Track* intervention. Blinding is
therefore not possible.

The new primary care intervention *Back on Track* (intervention)
The *Back on Track* intervention comprises four individual sessions (30
minutes) and eight group sessions (60 minutes), provided by physical therapists
in primary care. The intervention will include a combination of exercise
therapy with cognitive behavioral elements. Using a biopsychosocial approach,
patients will be stimulated to improve their perception and attitude about pain
and functional status.
Physical therapists will receive a treatment manual with information about each
session specifically and an education program (three evenings, four hours
each). Patients will receive a book in which patients can make notes and
homework.


Primary care as usual (control)
Content of consultations will not be protocolled, but therapists are requested
to follow the guideline for low back pain of the Royal Dutch Society for
Physical Therapy (KNGF Richtlijn, lage rugpijn). Patients will receive
maximally 12 individual sessions for a maximum of 8 weeks.

Patients with CLBP and a WPN2 and WPN3- classification will be recruited by
consultants in rehabilitation medicine, working at MUMC+ during a consultation
(regular care). Patients who were found eligible for the study will receive
both oral and written information (human subject information) about the study
via the consultant in rehabilitation medicine. When patients are willing to
participate in the study, the consultant in rehabilitation medicine asks for
permission by a written consent to collect general contact information about
the patient which will be send to the research team. The patient will be
invited for an intake at Maastricht University (approximately 1 hour) to
receive additional information about the study, to ask remaining questions, to
sign their informed consent and to perform baseline measurements (e.g.
questionnaires; t=1). Finally, the patient will be randomized (WPN2) or
allocated (WPN3-) to the specific treatment which will be both provided in
Maastricht and surrounding villages. Treatment will last for 7/8 weeks in
total. Directly after finishing the treatment (t=2) and after 3 months of
follow up (t=3), questionnaires will be completed again (approximately 45
minutes). The questionnaires can be completed online at the individual*s home
computer. In case patients are not able to fill in the questionnaires
electronically, they will be offered paper questionnaires. Paper questionnaires
will be send by post with a return envelope and stamp, what enables the
patients to return the questionnaires after completing.

It is expected that the risks associated with participation to the study are
negligible and that the burden will be minimal. Measurements that will be
conducted during the study consist of questionnaires only and are not invasive
or risk full. As discussed earlier, both treatments (intervention and control)
are executed as regular care for several years already. All physical therapist
will have basic knowledge about cognitive-behavioral principles since most
curriculums of physical therapy academies include aspects of these principles
(e.g. Graded Activity and Graded Exposure). In addition, physical therapists
will follow an education program to ensure that they will be competent in
providing the new intervention program and to ensure that the intervention will
be delivered in a standardized manner as well.

We expect that patients with CLBP classified as WPN2 and WPN3- will directly
benefit from the treatments. Furthermore, it is expected that the existing
waiting list in multidisciplinary settings will shorten, due to the fact the
study enables the patients to start the treatment in primary care almost
directly. The *Back on Track* intervention will use open group sessions. In
addition, the study enables the patients to receive treatments in physical
therapy practices which will be located closely to the patient*s home. These
physical therapy practices will probably be located more closely to the
patient*s home than multidisciplinary rehabilitation centers. The *Back on
Track* intervention might therefore minimize patient*s time for traveling.