Primary Objective: To evaluate if a sensor-based movement control intervention enhances movement control of the trunk in low back pain patients to a greater extent than a standard core stability intervention over the course of a multidisciplinary…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Trunk movement control
Average tracking error of three trunk-controlled tracking tasks on a laptop
(one flexion-extension, one lateral flexion, one rotation) at the beginning and
end of the intervention, reported in as average tracking error (degrees).
Secondary outcome
Trunk movement control
Results from clinical movement control tests of the low back.
Cycle-to-cycle variability of trunk rotations (degrees) during gait at low (2
km/h), comfortable (subject specific) and high (6 km/h) gait speed.
Cycle-to-cycle variability of trunk flexion during a repetitive bending task
while standing.
Cycle-to-cycle variability of trunk rotation during a repetitive
standing rotation task.
Therapy adherence
Number of individual therapy sessions present and reported reason for
missing a session (not scheduled / therapist absent / patient absent).
Dutch version of the Exercise Adherence Rating Scale for the prescribed
homework exercises.
Disability
Two questionnaires will be used.
(1) The Dutch version of the Oswestry Disability Index 2.1a.
(2) The Dutch version of the Roland Morris Disability Questionnaire.
*
Pain intensity
A numeric rating scale (0-10) for current, week-average, and
week-maximum pain intensity of the low back.
Fear Avoidance Beliefs
The Dutch version of the Fear Avoidance Beliefs Questionnaire.
Health related quality of life.
The scales *physical functioning*, *mental health*, *general health*
and *pain* from the Dutch version of the RAND-36.
Background summary
According to current evidence, the best treatment for low back pain is
exercise, preferably in combination with education. There is no evidence that
certain exercises work better than others. For this reason, guidelines such as
the Dutch Physiotherapy guideline recommend that the personal preferences of
the therapist and patient be taken into account.
In a considerable part of the intervention studies with a focus on physical
exercises, "core stability" exercises are offered. During these programs,
patients learn to selectively contract the deep trunk muscles (m.transversus
abdominis and mm. Multifidi) and fixate their spine during postures and
movements that gradually increase in complexity. Although these exercises are
more effective than no intervention, they are not superior to other physical
exercise interventions consisting of, among others, strength exercises,
stretching exercises and / or aerobic exercises.
Physical rehabilitation interventions usually aim at reducing functional
limitations, such as strength, flexibility, endurance or coordination. The
question is to what extent core-stability exercises eliminate limitations in
function. Patients with low back pain generally fixate their spine during
every-day movements. This behavior could be stimulated with core-stability
exercises. Patients with low back pain, on the other hand, do experience
problems performing controlled movements of the back. Designing exercises to
improve the movement control of the back is a challenge. Movement control over
less centrally located joints, such as the elbow or knee, can be trained using
simple tasks, such as bringing a spoon to the mouth or kicking a ball against a
pillon. The success of the execution (not spilling the soup or knocking over
the pillon) can be used as an indication of good control over the movement of
the joint. Giving meaningful feedback on back movements is much more
complicated. Sensors that measure the back movements can offer a solution.
There are several solutions available on the market, but no intervention
studies incorporating these technologies have yet to be performed.
Study objective
Primary Objective:
To evaluate if a sensor-based movement control intervention enhances
movement control of the trunk in low back pain patients to a greater extent
than a standard core stability intervention over the course of a
multidisciplinary rehabilitation programme.
Secondary Objective:
To evaluate if differences exist between the offered interventions in therapy
adherence and the effect on disability, pain intensity, physical fear avoidance
beliefs and health related quality of life.
Study design
Randomized Controlled Trial
Intervention
Both interventions will be offered over a course of eight weeks (week 2 - 9 of
the study), each week consisting of:
- Two supervised therapy sessions of 20-30 minutes
- Provided by experienced therapists (physiotherapist, occupational
therapists
(in Dutch: *ergotherapeuten*) and sport therapists) that will be trained to
provide the
intended interventions.
- The first six sessions will be individual, i.e., with one patient for
each session.
- The final ten sessions will be in groups, i.e., with a maximum of
three patients per
session.
- Seven non-supervised homework exercises of 5-10 minutes
One video-instruction for each week that will be performed each day of that
week.
These instructions will be available *unlisted* on YouTube, i.e., these
videos can be
viewed anonymously on any device (e.g., laptop, smartphone or tablet), but
only by
individuals that have a link to the video. Separate exercises will be
provided for each
intervention.
The supervised therapy sessions and homework exercises of the standard
core-stability intervention will consist of exercises in which participants
will be instructed to contract their m. transversus abdominis during a variety
of postures and body movements while keeping their spine *stable*, i.e., trying
to make as little spinal movements as possible. The exercises will be offered
with increasing intensity, difficulty and complexity.
For the supervised therapy sessions of the sensor-based movement
control intervention Valedo® Motion will be used. During each session, patients
will play a number of games that are controlled with spinal movements in a
variety of postures. Spinal movement is tracked using three inertial sensors
that are placed on the pelvis, the spine at the 12th thoracic vertebrae and the
sternum. The exercises will be offered with increasing intensity, difficulty
and complexity.
Study burden and risks
In general, exercise therapy results in small, but significant improvements in
function of low back pain, regardless of the exact type of exercises. Hence,
only relatively small advantages of being in a specific intervention groups are
to be expected.
The tests at the beginning and end of the intervention could result in a
transient increase in low back pain.
Training with sensors could result in spinal tissue overload as a result of
lack of focus on bodily sensations. Moreover, Valedo has not been used
previously at the Military Rehabilitation Center. As a result of this
inexperience, it could happen that the offered exercises for this group are
more often too intensive than for the core-stability group, which could result
in an increase of low back pain. However, the Military Rehabilitation Center
has more than 10 years of experience with providing a similar type of therapy
in low back pain patients. Moreover, the complexity, duration and intensity of
the exercises will be increased gradually, which would minimize the chance of
overloading the spinal structures.
Korte Molenweg 3
Doorn 3941PW
NL
Korte Molenweg 3
Doorn 3941PW
NL
Listed location countries
Age
Inclusion criteria
- Between 20 and 60 years of age
- Experienced low back pain on a daily basis over the last 3 months, with or
without accompanying leg pain above the knee.
Exclusion criteria
- Any condition (other than chronic low-back pain) that might interfere with
motor control of the trunk.
- A recent surgical intervention on the spinal column, proven serious pathology
of the
spine* and related structures (canal and/or foramen stenosis, spondylolysis,
spondylolisthesis, osteoid osteoma), infections, recent fractures or
psychiatric disorders.
- Signs of neurological compression, e.g., loss of sensory or motor functions
in the legs and/or pelvis and/or radiating pain in the lower leg and/or foot.
- The use of drugs that influence the reaction time (In the Netherlands, drugs
with a yellow sticker on the box that reads (translated): "This medication may
influence your reactions. Use with caution when driving a car or operating
dangerous machinery.").
- A Body Mass Index of 30 (kg/m2) or more as this could hamper the planned
movement control intervention as a result of movement artefacts.
- Implanted electronic devices of any kind, including cardiac pace-makers or
similar assistive devices, electronic infusion pumps, and implanted
stimulators.
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 |
---|---|
CCMO | NL76811.028.21 |