The effectiveness of a biopsychosocial rehabilitation program in Primary care (Back on Track) versus primary care as usual in patients with chronic low back pain in which psychosocial factors minimally influence daily life functioning: A Randomized Controlled Trial

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
multidisciplinary rehabilitation programs and are very costly. In addition,
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 may respond
differentially than patients with less psychosocial factors). It would
therefore be interesting to evaluate the effect of a biopsychosocial
intervention provided in primary care in a specific subgroup, particularly in
WPN2 since the contributing role of psychosocial factors in the maintenance of
disability is at maximum low.

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). This new intervention will be compared with regular
physical therapy in primary care settings. It is expected that the new primary
care intervention *Back on Track* will be more effective than regular primary
care physical therapy. Subsequently, it will be investigated whether the
primary care intervention *Back on Track* will be more cost-effective than
primary care as usual.

Primary Objective:
1. To assess the difference in treatment effect (change in functional
disability between pre-treatment and 12 months of follow-up post-treatment)
between the new primary care intervention *Back on Track* and primary care as
usual in patients with CLBP experiencing moderate levels 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 12 months of
follow-up post-treatment than a usual primary care intervention in patients
with CLBP experiencing a moderate level of disability and the contributing role
to this disability of psychosocial factors is at maximum low (WPN2).

Secondary Objectives:
1. To assess the difference in treatment effect (change in functional
disability between pre- and post-treatment) between the new primary care
intervention *Back on Track* and usual primary care in patients with CLBP
experiencing a 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 than a usual primary care intervention in patients with CLBP
experiencing a moderate level of disability and the contributing role to this
disability of psychosocial factors is at maximum low (WPN2).

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

3. To assess the difference in cost-effectiveness and cost-utility over a
one-year period between the new primary care intervention *Back on Track* and
primary care as usual in patients with CLBP experiencing a 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 over a one-year period in reducing
functional disability than primary care as usual in patients with CLBP
experiencing a moderate level of disability and the contributing role to this
disability of psychosocial factors is at maximum low (WPN2).

A multicentre (n=8) double-blind Randomized Controlled Trial (RCT) will be
conducted including a pragmatic design. Patients with CLBP and classified as
WPN2 will be recruited by consultants in rehabilitation medicine, working at
Maastricht University Medical Center (MUMC+). Patients will be randomized
(central randomization) to either the new *Back on Track* primary care
intervention or primary care as usual (ratio 1:1). Block-randomizations via a
computerized random number generator including bloksizes of 4,6 and 8 will be
used. No stratification. Both treatment conditions will be provided by physical
therapists in primary care. Four physical therapy practices will provide the
new *Back on Track* primary care intervention and four physical therapy
practices will provide the primary care as usual intervention. The selected
physical therapy practices in the study will be located in Maastricht and
surrounding villages.

In total, both treatment conditions (the *Back on Track* intervention and
primary care as usual) will last for 8 weeks maximally. Physical therapists who
will provide the "Back on Track" intervention will receive a treatment manual
and education program (three education meetings). Protocol adherence will be
assessed using audio recordings. Patients will receive a workbook with
explanations, illustrations and home assignments. Primary care as usual will
comprise of regular physical therapy. Therapists will not receive a treatment
protocol or educational program. It is expected that therapists will use the
guideline for low back pain of the Royal Dutch Society for Physical Therapy
(KNGF Richtlijn, lage rugpijn) during their consultations; however
consultations will not be protocolled. Physical therapists are only advised to
use maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks
to preserve from endless treatments.

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.

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 book in which patients can make notes and
homework (for detailed information see protocol)

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). Physical therapists are only
advised to use maximally 12 individual sessions (30 minutes each) for a maximum
of 8 weeks to preserve from endless treatments.

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 a set of questionnaires only and are not
invasive or risk full. The patient will be invited for an intake at Maastricht
University (±1 h) and need to complete the CEQ-questionnaire (±5 min.) and T2-,
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. Since care as usual is not protocolled, an accurate
estimation about the required time for therapy cannot be provided. The study
will restrict physical therapists providing care as usual only to provide
maximal 12 individual sessions (30 minutes each) for a maximum of 8 weeks. No
additional risks for *care as usual* are expected since therapists will provide
primary physical therapy as usual which is regular care in primary care
settings.
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. In addition, cognitive behavioral interventions
seem effective in reducing fear-avoidance beliefs and anxiety/depression. 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. 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. 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 WPN2 classification. These patients are classified as not
having extreme or complex psychosocial factors and high levels of disability.
Therefore, it is expected that the *Back on Track* intervention will not be
risk full. All patients with complex psychosocial factors and high levels of
disability will not be included in the study.

We expect that patients will directly benefit from both interventions (*Back on
Track* intervention and primary care as usual). Since the *Back on Track*
intervention will focus on all biopsychosocial factors it is expected that this
intervention will be more effective than primary care as usual and that these
results will be maintained in long-term follow-up. Patients that will receive
the *Back on Track* intervention will be stimulated to generalize aspects of
the treatment to their daily life. 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 what might stimulate interaction
between patients what might be beneficial for the rehabilitation process of the
patient. A further aim of this study is to keep waiting lists to a minimum by
using *open* group session in the *Back on Track* intervention. 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 can 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 that were included
earlier, while earlier included patients might recognize own improvements when
comparing themselves with new patients. Another important benefit is the fact
that the study will refund traveling expenses to Maastricht University and
physical therapy costs. Refunding therapy costs will enable all patients to
receive physical therapy, irrespective of their health care insurance.