Clinical trial NCT03399968: Extracorporeal Shockwave Therapy (ESWT) to Improve Function in Chronic ASIA-A Patients
Official title: Extracorporeal Shockwave Therapy (ESWT) in Patients Suffering From Complete Paraplegia at the Thoracic Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: shockwave
ESWT
Lead sponsor: AUVA Trauma Center Meidling
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled double blinded clinical intervention study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* patients with a spinal cord injury classified as ASIA A between the level of THII to THX (complete central lesion)
* at least 1 year after trauma
* no signs of spontaneous recovery over the last 6 months
* signed informed consent

Exclusion Criteria:

* central therapies over the last 6 months (eg stem cells, electro-therapy)
* Baclofen pump
* Joint contraction lower limb \> 40° (hip or knee)
* Body weight \> 135 kg
* Body height \> 202 cm
* non-compliant patients
* Decubital ulcers at grade II or higher
* participation in an other clinical trial within the last 6 months
* Co-morbidities which make study completion doubtful or impossible
* Additional neurological diseases which may lead to further damage to the nerval system
* Malignant tumor

Primary outcomes:
measure: Motor function
timeFrame: 24 weeks
Secondary outcomes:
measure: Sensitivity and Motor function
timeFrame: 24 weeks
measure: Spasticity
timeFrame: 24 weeks
measure: Trunk control
timeFrame: 24 weeks
measure: Lung function
timeFrame: 24 weeks
measure: Quality of life
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Klosterneuburg
country: Austria
facility: AUVA Rehabilitation Center Weisser Hof
state: Lower Austria
city: Haselsdorf
country: Austria
facility: AUVA Rehabilitation Center Tobelbad
state: Styria
Study officials:
References: