To investigate the short-term (3 months) effectiveness on physical functioning, and the long-term (24 months) cost-effectiveness, of a personalized stratified blended care intervention (e-Exercise LBP) in comparison with usual physical therapy in…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the short-term improvement of lower back related
physical functioning and the long-term reduction of low back pain related
costs.
Secondary outcome
Different secondary and other study parameters will be measured to describe the
study population, to determine the (cost)-effectiveness of e-Exercise LBP and
adjust the statistical analysis for potential confounders:
Secondary study parameters: Pain intensity, physical activity, adherence to
prescibed home exercises, psychological functioning, self-efficacy,
self-management skills, the number of reccurent low back pain episodes, and
health related quality of life.
Other study parameters: Patient characteristics, the risk of developing
persistent low back pain, central sensitization, the usability of the
e-Exercise low back pain app, and the content and number of physical therapy
sessions.
Experiences with selfmanagement behavior of patients with chronic low back pain
after following e-Exercise Low Back Pain.
Background summary
Non-specific low back pain is the most common cause of disability in western
society. Physical therapy is recommended for patients with non-specific low
back pain in national and international guidelines. Recently, research has
shown that a stratified-care approach based on patients* prognostic risk
profile led to similar outcomes, higher quality-adjusted life years for
patients, and lower health costs. However, applying a stratified-care approach
is currently not common practice in Dutch primary care. Furthermore, research
has shown that the effectiveness of physical therapy highly depends on
patients* adherence to physical activity and home-based exercise
recommendations. Blended care, the integration of e-health technology into
physical therapy care appears promising for improving physical therapy care
outcomes and patients* adherence in the short- and long-term.
Study objective
To investigate the short-term (3 months) effectiveness on physical functioning,
and the long-term (24 months) cost-effectiveness, of a personalized stratified
blended care intervention (e-Exercise LBP) in comparison with usual physical
therapy in patients with non-specific LBP.
Study design
Prospective cluster randomized controlled trial. Randomization will be done at
the level of the participating physical therapy practices.
Intervention
In the intervention group patients with non-specific low back pain are
stratified into three different groups based on the risk to develop persistent
low back pain. Patients are treated using a blended care approach (e-Exercise)
in which online e-health modules are an integral part of face-to-face physical
therapy treatment. The e-Exercise low back pain program is an app containing
information and self-management modules, a home-based exercise module and
offers remote support to increase adherence to physical activity and exercise
recommendations. Patients in the control group receive usual physical therapy
care according to the Royal Dutch Association for Physical Therapy Guideline
for the treatment of non-specific low back pain.
Study burden and risks
Patients are asked to complete a number of questionnaires at baseline, 3, 12
and 24 months. Additionally, the patients are asked to report on healthcare
utilization and (unpaid) productivity losses retrospectively every 3 months for
the duration of the trial. The content of the intervention is based on current
literature, guidelines and focus groups with patients, physical therapists and
experts. Therefore, risks for participating patients in the experimental group
is expected to be similar to usual physical therapy care.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Patients with non-specific low back pain will be recruited within the
participating physical therapy practices. In order to be eligible to
participate in this study, a patient must meet all of the following criteria:
- being a patient applying for physical therapy for non-specific low back pain;
- aged 18 years or older;
- non-specific low back pain, defined as pain in the lumbosacral region
(sometimes associated with radiating pain to the buttock or leg) in the absence
of an identifiable underlying cause;
- possessing a smartphone or tablet with access to the internet;
- mastery of the Dutch language.
Exclusion criteria
A potential patient who meets any of the following criteria will be excluded
from participation in this study:
- low back pain due to a possible specific cause trough medical imaging or a
medical doctor (e.g. osteoporotic fractures, spinal nerve compromise,
malignancy, ankylosing spondylitis, canal stenosis, or severe
spondylolisthesis).
- serious comorbidities (e.g., malignancy, stroke);
- current pregnancy, due to the prevalence of pelvic girdle pain as a specific
form of LBP.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ISRTCN: 94074203 |
| CCMO | NL64425.041.18 |