A multi-centered analysis on the effect of eHealth and usual care in IBD patients with peripheral artralgia

Arthropathies are the most common extra-intestinal manifestations (EIMs) in
inflammatory bowel disease (IBD), with a prevalence of approximately 30%.
IBD-associated arthropathies can be divided into inflammatory and
non-inflammatory joint complaints and may involve both axial and peripheral
joints. Non-inflammatory joint pain, or arthralgia, is one of the most common
complaints in daily IBD practice. Rheumatologists classify arthritis associated
with IBD within the group of spondyloarthritis (SpA) disorders. SpA is a group
of rheumatic diseases characterized by inflammation of the spine and the
sacroiliac (SI) joints. Gastroenterologists should differentiate SpA patients
from non-SpA patients to make a distinction between the patients that should be
referred to a rheumatologist and the patients that should remain under
supervision of the gastroenterologist. The ASAS criteria represent the most
practical system with which to classify axial and peripheral SpA and are thus
particularly applicable in the clinic, because based on this approach all the
subtypes of SpA will be recognized as distinct disease. Patients who do not
fulfil the ASAS criteria (around 85%) can be classified as having arthralgia
and remain under the supervision of the gastroenterologist. Care optimization
is needed to treat IBD patients with arthralgia since it can have an enormous
impact on the quality of life.
Different therapeutic and non-therapeutic interventions have been applied and
described in IBD patients with arthralgia. We define usual care in patients
with arthralgia as pain medication therapy, like paracetamol, NSAID crème,
celecoxib, tramadol and oxycodone, in which the type of medication depends on
the severity of the complaints. Besides this therapeutic intervention,
non-therapeutic interventions have been evaluated in different cohorts with
joint complaints. Previous studies in Rheumatoid Arthritis (RA) and
fibromyalgia patients have evaluated the effect of cognitive-behavioral therapy
on the reduction of pain severity, coping and improved health status, measured
with the VAS scores and the SF-36 questionnaire. The purpose is to reduce the
negative effects associated with joint complaints. Positive significant
reductions of the VAS score and SF-36 have been found between patients with
non-therapeutic interventions compared with controls.
In the past decade, the use of internet-based cognitive behavioral therapy has
grown intensively. A previous study of internet -based interventions applied to
RA patients found that most patients would be willing to receive such
treatments. Results show that having no travelling time, being able to choose
for yourself when you want to participate, and not having to wait for
therapists were advantages most often endorsed by patients. Making your own
choice about when you want to spend time on therapy could enhance the energy
and motivation to participate.
Since gastroenterologists have difficulties in managing and diagnosing joint
complaints, care optimization in IBD patients with arthralgia is needed. In
this study we propose to evaluate the effect of this non-therapeutic therapy
with the usual drug therapy.

Primary objective: To evaluate the effects of eHealth therapy and usual care in
IBD patients with arthralgia and to compare the effects of eHealth
interventions plus usual care with just usual care in IBD patients with
arthralgia.

A prospective randomized-controlled trial comparing the effect of eHealth
intervention and usual care in IBD patients with peripheral arthralgia based on
coping, quality of life and pain reduction. Consecutive patients from the
participating centers diagnosed with peripheral arthralgia meeting the
inclusion criteria will be informed about the study at the outpatient clinic
and by postal mail. Within one week, patients are asked for informed consent.
If both patient and gastroenterologist sign informed consent, subjects will be
randomized between usual care and the eHealth intervention group.
Arm 1: Usual care. At inclusion, patients will complete the VAS pain score to
measure the severity of the arthralgia. Additionally, patients will complete
the VAS coping score and the SF-36 questionnaire to measure coping and the
impact of their joint pain on daily life. Medication is prescribed according to
the protocol (supplement 2). Patients will be followed for 4 months and dosage
can be increased or medication can be changed. At the end of the study period
again the VAS pain and coping scores and SF-36 questionnaire will be completed
to evaluate the effect between baseline and after the 4-month follow-up. If
patients already use medication, the medication can be changed and intensified
according to the protocol.
Arm 2: eHealth intervention in combination with usual therapy. At inclusion,
patients complete the VAS score to measure the severity of the arthralgia at
baseline. Patients will also complete the VAS coping score and the SF-36
questionnaire to measure their coping and impact of their joint pain in daily
life. This intervention includes a customized therapy for every individual and
the intensity and duration depends on the severity of the joint complaints.
Aside from the eHealth intervention, usual drug therapy is started/changed
according to the protocol. The eHealth therapy will be offered via the internet
with the main focus on self-management. The patient starts the therapy online
and has weekly contact with the therapist. The eHealth intervention consists in
total of 6 modules. The modules are based on different themes, in which the
patient learn how to cope with the pain and new skills will be learned based on
personal goals, psycho-education, assessments and relaxing exercises. The
themes that will be emphasized are mood, activity and fatigue, thoughts,
communication and social environment. The therapist gives online feedback and
the patient is able to ask questions if necessary. At the end of the study
period, the pain and coping VAS scores have to be completed together with the
SF-36 questionnaire to evaluate the effect of eHealth intervention on the
reduction of joint complaints compared with the control group.

Strategy 1: Usual care. At inclusion, patients will complete the VAS score to
measure the severity of the arthralgia. Additionally, patients will complete
the VAS coping score and the SF-36 questionnaire to measure their coping and
impact of their joint pain in daily life. After this, medication is prescribed
related to the extent of the disease. Patients will be followed for 4 months
and dose can be increased or medication can be changed. Patients are requested
to keep a diary of their currently used medication. The usual drug therapy will
gradually be given (supplement 2):
- Paracetamol 1000 mg 3x/day,
- NSAID cream
- Celecoxib 100 mg 2x/day
- Tramadol 50 mg 3x/day
- Oxycodone (dose determined by gastroenterologist according to the severity of
the complaints)
At the end of the study period the VAS pain and coping scores and SF-36
questionnaire will have to be completed to evaluate the effect on pain
reduction, quality of life and coping due to this strategy.

Strategy 2: eHealth in combination with usual therapy. At inclusion patients
will complete the VAS score to measure the severity of the arthralgia at
baseline. Additionally, patients will complete the VAS coping score and the
SF-36 questionnaire to measure their coping and impact of their joint pain in
daily life. After this, usual therapy is started or medication is changed. The
patient will be treated via the internet and the therapy will be adapted to the
severity of the joint complaints. During the follow up patients will be seen a
few times by the therapist and are prompted to keep a diary about their
medication. At the end of this therapy, patients are requested to complete the
VAS score.

n.a.