Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-05 @ 2:28 AM
Study NCT ID:
NCT03399968
Status:
UNKNOWN
Last Update Posted:
2019-07-05
First Post:
2018-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Shockwave Therapy (ESWT) to Improve Function in Chronic ASIA-A Patients
Sponsor:
AUVA Trauma Center Meidling
Organization:
Study Overview
Official Title:
Extracorporeal Shockwave Therapy (ESWT) in Patients Suffering From Complete Paraplegia at the Thoracic Level
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: