The added value of a behavioural weight reduction program to blended rehabilitation in patients with chronic low back pain: A randomized clinical trial

Chronic low back pain (CLBP) is the most common and important clinical, social,
economic, and public health problem of all chronic pain disorders across the
world. In addition to its high prevalence, CLBP is a severely disabling
disorder characterized by tremendous personal and socioeconomic impact, with
long-term sick-leave, low quality of life and very high socio-economical costs.
CLBP is the most expensive cause of work-related disability - it causes the
highest number of years lived with disability.

The most severe and debilitated CLBP patients often have comorbidities such as
overweight and obesity: pain intensity and disability in people with CLBP show
dose-responses to body mass index (BMI), waist circumference, percent fat and
fat mass. Meta-analyses confirm that overweight and obesity are associated with
LBP, with overweight and obesity identified as risk factors for LBP. Regarding
socio-economic impact, overweight or obesity is not only related to LBP
persistence, but also to higher rates of health care seeking for LBP.
Obviously, people with CLBP who are overweight or obese, are likely to have
more complex health needs requiring focus on lifestyle behavioral factors such
as physical activity/exercise and diet.

CLBP is a complex disorder which is difficult to treat. Exercise therapy is an
evidence based treatment for CLBP: both general exercises and
cognition-targeted exercise therapy have shown beneficial effects on pain in
patients with CLBP. Unfortunately, current treatments for CLBP apply a *one-
size-fits-all* approach and do not address comorbidities like obesity. This
knowledge gap is now acknowledged internationally. Overweight and obesity are
increasingly recognized as a plausible therapeutic target for people with CLBP.
Despite the growing body of scientific literature pointing towards the close
interaction between overweight/obesity and CLBP, few treatment programs for
people with CLBP nowadays take overweight into account.
A few studies explored the added value of weight reduction to the management of
people with CLBP. Yet, proof of concept for combining dietary changes with
exercise therapy for patients with CLBP and comorbid overweight/obesity can be
found in two main lines of research:

1) A small-scale proof of concept study showed that obese people with CLBP
(n=46) not only lost body weight but also experienced reduced disability and
48% less pain following a nonsurgical weight loss program, comprising of
changes in dietary behavior and exercise therapy. Although compelling, the
proof-of-concept study was uncontrolled (pre-experimental design), precluding
causal interpretation of the study findings. One Australian trial explored
effects of a telephone-based lifestyle behavioral intervention in reducing pain
in overweight or obese patients with LBP.
The trial is well designed, but the treatment mode was only telephone based,
possibly explaining why the intervention was unable to alter the patients*
diet, reduce body weight or increase physical activity, and no positive changes
in pain severity were observed. Poor engagement (29% compliance rate) in the
program may also explain the negative findings.

2) Extensive evidence in overweight/obese adults with knee osteoarthritis: Six
high-quality randomized controlled trials showed that dietary changes combined
with exercise therapy result in better outcomes (i.e., weight loss associated
with improvements in pain and function) compared to dietary changes or exercise
therapy alone in overweight/obese adults with knee osteoarthritis.
Additionally, one study examined the effects of a treatment that combined pain
coping skills training with behavioral weight reduction. This combined approach
was more
effective to reduce pain, disability, and pain catastrophizing, compared to
either intervention alone or a control intervention. These authors concluded
that a behavioral intervention that simultaneously addresses pain and weight
(i.e., a similar intervention as proposed in this application) can enhance the
ability to comply with the needed lifestyle changes to lose weight, which leads
to an improvement in pain and disability. A recent systematic review identified
the need for well-designed, high-quality randomized controlled trials to
examine this combined treatment in a large population of adults with CLBP and
comorbid overweight/obesity.

For all these reasons, here we propose studying the added value of a behavioral
weight reduction program (changes in diet, behavior and physical exercise) to
blended rehabilitation (pain neuroscience education plus cognition-targeted
exercise therapy) for overweight or obese people with CLBP. Both treatments are
effective in their specific target population (i.e., behavioral weight
reduction for overweight/obese people and pain neuroscience education plus
cognition-targeted exercise therapy for people with CLBP and normal BMI), but
whether their combined approach is cumulative in overweight/obese people with
CLBP is currently unknown and represents an important research priority.

The primary scientific objective of this multicenter study is to examine if
adding a behavioral weight reduction program to pain neuroscience education and
cognition-targeted exercise therapy, compared to pain neuroscience education
and cognition-targeted exercise therapy alone, results in less pain at 6 months
follow-up in overweight or obese people with CLBP? Secondary objectives of the
study are to examine if adding a behavioral weight reduction program to pain
neuroscience education and cognition-targeted exercise therapy, compared to
pain neuroscience education and cognition-targeted exercise therapy alone,
results in improved function, body composition, physical activity, sedentary
behavior, fear avoidance, pain catastrophizing and dietary intake at 6 months
follow-up in overweight or obese people with CLBP? All interventions will be
delivered online or in
person within a blended approach, using 1-on-1 appointments with a therapist in
person, online instructive videos, challenges to complete online, online
quizzes, online booklets, and online diaries/workbooks.

The overall study design is a Double-blind (participants and statistician)
randomized controlled trial (phase III), including two comparative, balanced
treatment arms. The trial will compare a behavioral weight reduction program to
pain neuroscience education and cognition-targeted exercise therapy
(experimental treatment), to pain neuroscience education and cognition-targeted
exercise therapy alone (control treatment). All interventions will be delivered
online and in person in a blended approach. The total study-duration for the
participants (from inclusion to last follow-up assessments) is 9
months. Screening and baseline assessment of one participant will take one
week. The questionnaires will be filled out at home (duration to fill all
questionnaires out = max. 20 minutes). Both treatment arms include a treatment
that lasts 10 weeks. The study ends with the last follow-
up assessments, 6 months after therapy completion.

All participants will receive a combination of an online therapy program and
three 1-on-1 sessions with a physical therapist in person, within a 10-week
period. The online therapy (using the platform www.teachable.com) is delivered
using a blended approach and consists of instructive videos, challenges to
complete, online quizzes, online booklets, and online diaries/workbooks. The
experimental group will receive a behavioral weight reduction program combined
with pain neuroscience education plus cognition-targeted exercise therapy. The
combined therapy will adhere to guidelines for patient-centered care, including
offering an individualized treatment, continuous communication, education
during all aspects of treatment, working with patient-defined goals in a
treatment in which the patient is supported and empowered with a therapist
having social skills, being confident and showing specific knowledge. Therapy
is provided online and in person, and will be provided in different *chapters*,
allowing the patient to go through the information step-by-step since
information will be released in small parts. This way, all participants will
need 10 weeks to go through the complete program and treatment duration will be
standardized.

Previous studies have investigated comparable interventions and there are no
adverse events known by any of these studies. Also all interventions
investigated in this study are already used during usual care by many
therapists across the world and are recommended interventions described in
different guidelines in the treatment of obesity and/chronic low back pain.