A primary care biopsychosocial intervention (Back on Track) for patients with chronic low back pain in which psychosocial factors moderately influence daily life functioning: A pilot study

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 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, it would therefore be interesting to
evaluate the effect of such intervention in a specific subgroups, particularly
in WPN3- since the contributing role of psychosocial factors in the maintenance
of disability is mild to moderate.

This pilot study will therefore focus on the feasibility and effectiveness of a
newly developed primary care intervention *Back on Track* which is based on
multidisciplinary pain rehabilitation interventions in improving daily life
functioning in patients with CLBP who experience moderate levels of disability
and the contributing role to this disability of psychosocial factors is mild to
moderate (WPN3- classification). It is expected that the new primary care
intervention *Back on Track* will improve functional disability in this
subgroup of patients with CLBP which normally receive multidisciplinary pain
rehabilitation interventions.

Primary Objective:
1. To assess whether the primary care intervention *Back on Track*
significantly improves functional disability (QBPDS) between pre- and
post-treatment in patients with CLBP experiencing a moderate to high level of
disability and in which the contributing role of psychosocial factors to this
disability is mild to moderate (WPN3-).

Hypothesis: It is hypothesized that the new primary care intervention *Back on
Track* will significantly improve functional disability between pre- and
post-treatment in patients with CLBP experiencing a moderate to high level of
disability and in which the contributing role of psychosocial factors to this
disability is mild to moderate (WPN3-).

Secondary Objective:
1. To assess whether the primary care intervention *Back on Track*
significantly improves functional disability (QBPDS) between pre-treatment and
3 months of follow-up in patients with CLBP experiencing a moderate to high
level of disability and in which the contributing role of psychosocial factors
to this disability is mild to moderate (WPN3-).

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

2. To assess whether the primary care intervention *Back on Track*
significantly improves functional disability (QBPDS) between pre-treatment and
12 months of follow-up in patients with CLBP experiencing a moderate to high
level of disability and in which the contributing role of psychosocial factors
to this disability is mild to moderate (WPN3-).

Hypothesis: It is hypothesized that the new primary care intervention *Back on
Track* will significantly improve functional disability between pre-treatment
and 12 months of follow-up in patients with CLBP experiencing a moderate to
high level of disability and in which the contributing role of psychosocial
factors to this disability is mild to moderate (WPN3-).

3. To assess the feasibility of the new primary care intervention *Back on
Track* in terms of treatment expectations and credibility, treatment fidelity
(quality), dose delivered (completeness), reach (participation rate), and dose
received (exposure & satisfaction). (Process evaluation)

Hypothesis: It is hypothesized that the new primary care intervention *Back on
Track* is feasible in terms of treatment expectations and credibility,
treatment fidelity (quality), dose delivered (completeness), reach
(participation rate), and dose received (exposure & satisfaction).

A pilot study with a pre-post test design will be conducted involving patients
with CLBP and classified as WPN3-. Patient recruitment will be executed by
consultants in rehabilitation medicine, working at Maastricht University
Medical Center (MUMC+). Patients will have the opportunity to participate in
the study and to receive the *Back on Track* intervention or not to participate
in the study and receive multidisciplinary care as usual. Since participation
would automatically mean that they will receive the *Back on Track*
intervention, randomization and blinding is not applicable.

In total, the new *Back on Track* primary care intervention will last for
approximately 8 weeks. The *Back on Track* intervention will be provided by
physical therapists in primary care and will comprise of four individual
sessions (30 minutes) and eight group sessions (60 minutes) using a
biopsychosocial approach. In order to standardize the new *Back on Track*
primary care intervention, physical therapists who will provide this
intervention will receive a treatment manual and education program which
consist of three education meetings of 4 hours. Protocol adherence will be
assessed using audio recordings.


Overall, patients need to complete web-based questionnaires at four time
points:
T1 = prior to the therapy
T2 = directly after completing the therapy
T3 = after three months follow-up
T4 = after twelve months follow-up

In addition, both therapists and patients will be asked to complete the
CEQ-questionnaire directly after the first treatment and return it.

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. 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 workbook with explanations, illustrations and
home assignments.

It is expected that the risks associated with participation to the study are
negligible and that the burden will be minimal. The measurements that will be
conducted during the study consist of questionnaires and are not invasive or
risk full. The patient will be invited for an intake at the UM (±60 min) and
need to complete the CEQ-questionnaire (±5 min.) and T2- (±50 min), T3-, and
T4-questionnaires at home (±45 min). In total, the burden for the patient to
participate in this study will be approximately 3.5 hours. In addition, the
*Back on Track* intervention will include approximately 10 hours divided over
7/8 weeks.
Overall, the *Back on Track* intervention is based on elements of
cognitive behavioral interventions used in multidisciplinary pain
rehabilitation settings (MUMC+ and Adelante, Hoensbroek, the Netherlands).
Literature addresses the importance to implement these principles in the
management of CLBP since these principles proved to be effective in reducing
functional disability and pain. The *Back on Track* will in part focus on
elements of GA and GE. Advice, education about pain and potential influencing
factors will be provided and patients will be stimulated to be physically
active. The intervention will inspire confidence, attempts to reduce
kinesiophobia and pain-related fear, and will stimulate patients to have
pleasure in being active (for detailed information, see protocol § 5.1). All
these elements are implemented in the MUMC+ and Adelante for more than 20 and
25 years respectively, without any problems or negative effects. Also
literature reported no adverse events when providing cognitive behavioral based
therapies. Since most curriculums of physical therapy academies include
cognitive-behavioral principles it is expected that general physical therapists
in primary care already possess basic knowledge about cognitive-behavioral
principles used in the *Back on Track* intervention. It is therefore expected
that the *Back on Track* intervention will be provided appropriately and
without any additional risk. Physical therapists that will provide the *Back on
Track* intervention will receive a treatment manual, an educational program and
will make audio recordings in order to standardize the treatment and to assess
protocol adherence.
As stated before, the *Back on Track* intervention focuses on exercise
therapy as well. There is no evidence that exercise would increase the risk of
future low back pain episodes. In contrast, literature showed that increased
physical activity status would be beneficial and safe for people with low back
pain. Increased physical status would prevent from future low back pain
episodes.
Overall, it is important to keep in mind that this study will include
only patients with a WPN3- classification. These patients are classified as
having no extreme or complex psychosocial factors and high levels of
disability. Therefore, it is expected that the risks associated to the *Back on
Track* intervention will be negligible. All patients with complex psychosocial
factors and high levels of disability will not be included in the study.
Furthermore, the consultant in rehabilitation medicine will keep responsibility
for the treatment period and will be involved throughout the process. After the
treatment period, all patients will receive a final evaluation with their
consultant in rehabilitation medicine. The consultant in rehabilitation
medicine will indicate the improvement of the patients, the patients* behaviors
and the ability to generalize aspects from the intervention towards their home
situation. This final evaluation with the consultant in rehabilitation medicine
is comparable with regular care in multidisciplinary settings.

We expect that patients will directly benefit from the *Back on Track*
intervention. The *Back on Track* intervention will focus on psychosocial
factors and is assumed to have benefits on long-term. Patients will be
stimulated to generalize aspects of the treatment to their daily life during
the treatment. Patients will receive a workbook as well. This will enable the
patient to appropriately understand information provided in therapy and to
reread this information. In addition, the *Back on Track* intervention will
provide group sessions which might stimulate interaction between patients and
might be beneficial for the rehabilitation process of the patient. Another
important benefit of the *Back on Track* intervention is the absence of waiting
lists. Especially multidisciplinary cognitive behavioural treatments deal with
large waiting lists. Since the *Back on Track* intervention uses open group
sessions, it is expected that patients are able to start with the intervention
almost directly. It is expected that an open group system will result in a
continuous inflow of new patients and outflow of patients finishing the
intervention. Patients do not need to wait for a new group but continue their
rehabilitation program. Furthermore, it is expected that patients might benefit
from these open group sessions since patients on different levels might inspire
each other. New patients might be stimulated and might learn from patients who
were included earlier, while earlier included patients might recognize own
improvements when comparing themselves with new patients. Furthermore, the
*Back on Track* intervention will be performed in physical therapy practices
which will be located closely to the patient*s home. These physical therapy
practices might be located more closely to the patient*s home than
multidisciplinary rehabilitation centres. The *Back on Track* intervention
might therefore minimize patient*s time for traveling. Another important
benefit is the fact that the study will refund all traveling expenses to
Maastricht University and physical therapy costs for the study. Refunding
therapy costs will enable all patients to receive physical therapy,
irrespective of their health care insurance.