To investigate the influences of MVF on pain and motor function in CRPS related dystonia and to investigate the feasibility of an MVF intervention in patients with CRPS related dystonia and the suitability of several outcome measures to determine…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain will be assessed twice a day using a Visual Analogue Scale (VAS) before
and after the first and last MVF session. The Burk Fahn Marsden scale will be
used to assess the severity of dystonia. Range of Motion will be assessed using
a goniometer and a rapid finger movement task is performed to test the velocity
and fluency of movements (bradykinesia). Two self-administered questionnaires
will be completed to assess the level of disability (Radboud Skills
Questionniare) and the neglect-like syndrome (Neuro Behavioral Questionnaire).
Secondary outcome
-
Background summary
Dystonia is the most common type of movement disorder that may arise in Complex
Regional Pain Syndrome (CRPS). One of the main concepts behind the development
of CRPS and dystonia is that it is caused by neuroplastic changes in the
central nervous system. It is thought that pain and motor symptoms in CRPS are
caused by incongruence between motor commands and sensory feedback in the motor
and somatosensory cortices. One strategy to alter the incongruence between
motor commands and sensory feedback is Mirror Visual Feedback (MVF). By
activating the cortical networks that serve the affected limb, symptomatic and
functional improvements can be attained. Several studies with amputees who
suffered from phantom limb pain (PLP) and phantom spasmsshowed successfull
treatment of pain and motor impairments using MVF. PLP and CRPS are both
considered pathological pain syndromes with comparable pathophysiology and
motor impairments. The comparable pathophysiology and motor impairments suggest
that MVF might be effective to improve motor impairments in CRPS related
dystonia. So far, this has never been studied, and therefore the aim of this
pilot study is to investigate the influences of MVF on pain and motor function
in CRPS related dystonia.
Study objective
To investigate the influences of MVF on pain and motor function in CRPS related
dystonia and to investigate the feasibility of an MVF intervention in patients
with CRPS related dystonia and the suitability of several outcome measures to
determine the influences (effects) of MVF.
Study design
The proposed pilot study will be conducted as an open clinical trial.
Intervention
Patients will undergo a six week treatment protocol. The first two weeks of are
part of a Graded Motor Imagery program as a preparation for the MVF. In the
first week, photographs of hands in different positions and angles are shown to
each patient. Subjects are asked to push a left or right the button according
to whether the picture shows a left or a right hand. In the second week
patients are asked to imagine adopting the posture shown with a smooth and
pain-free movement.
From the third week patients will receive MVF. The affected hand is concealed
behind the mirror and subjects watch the reflection of the unaffected hand in
the mirror. During the four weeks of MVF patients are asked to perform
exercises of increasing difficulty while watching in the mirror. Exercise will
be performed five times a day.
Study burden and risks
Some patients may experience some nausea, dizziness or a temporary increase of
pain during or directly after exercising with a mirror. Increasing pain is
mainly experienced during active movement of the affected limb in chronic CRPS
patients. Pain disappears after rest. Nausea and dizziness is only experienced
while looking in the mirror. The exact numbers of patients experiencing these
side affects in MVF are unknown. Most studies involving MVF in CRPS do not
report any side affects. If nausea or increasing pain occurs, patients are
advised to stop exercising immediately and continue at a later time. If
patients experience nausea or pain continuously during mirror exercises, they
are advised to contact the researcher. Patients fill out the pain scores twice
a day before and after the first and last therapy session. These scores are
safety checks and will be checked each time the patient visits the hospital for
the measurements and during telephone consults.
albinusdreef 2
2300 RC Leiden
NL
albinusdreef 2
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Subjects fulfill the CRPS criteria of the International Association for the Study of Pain (IASP).
Subjects score at least 2 points on the upper limb item of the Burke Fahn Marsden scale
(BFM).
Subjects have an unaffected contralateral limb.
Subjects are at least 18 years or older.
Subjects are familiar with written and spoken Dutch language.
Subjects who are on stable medication and do not expect any changes in medication or treatment over the course of the study. (3 months)
Exclusion criteria
Subjects with an internal medication pump.
Recent use (<12 wks) of Ketamine, Magnesium or Botuline Toxin treatments.
Lesions or disease of central nervous system that are associated with pain and/or motor impairment other than caused by CRPS or dystonia.
Psychiatric history.
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 | NL33004.058.10 |