Spinal Cord Injuries Clinical Trial
Official title:
Extracorporeal Shockwave Therapy (ESWT) in Patients Suffering From Complete Paraplegia at the Thoracic Level
The global prevalence of spinal cord injury is estimated between 236 to 4187/Million. A
spontaneous recovery of the sense-motoric function is decreasing with the time after injury
and is only seen sporadically after 1 to 2 years. Treatment options are mainly limited to
improvement of the quality of life.
The present prospective randomized study is intended as a double-blind, placebo controlled
multi-center investigation. Patients suffering from chronic paraplegia (lesion between THII
and THX, ASIA A = complete central lesion) at least for 1 year after the initial trauma
without spontaneous remission of the last 6 months are considered to be included in the
study. Meeting the inclusion criteria and signing the informed consent, patients are treated
in one of the two study centers. At study inclusion, a baseline evaluation comprising
neurological, neurophysiological, functional and clinical investigation is performed.
Patients dedicated to the ESWT intervention group will be treated once a week over 6 weeks
with local non-invasive low energy extracorporeal shockwave therapy (=6 treatments with an
electrohydraulic device). The follow-up will include neurological, neurophysiological,
clinical as well as functional evaluation at the time points 6 weeks, 3 months and 6 months.
Additionally, patients will be provided with a diary for documentation of drug adaptation,
grade of spasticity and pain. Those patients dedicated to the Placebo ESWT group, will
receive the identical scheme in treatment (but without application of shockwaves) and
follow-up as the patients in the ESWT group. However, after positive completion of the study,
these patients will be offered ESWT as well.
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