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Extracorporeal Shockwave Therapy (ESWT) to Improve Function in Chronic ASIA-A Patients

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ClinicalTrials.gov Identifier: NCT03399968
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
AUVA Trauma Center Meidling

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: ESWT Device: Placebo ESWT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized controlled double blinded clinical intervention study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extracorporeal Shockwave Therapy (ESWT) in Patients Suffering From Complete Paraplegia at the Thoracic Level
Actual Study Start Date : March 26, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ESWT
Application of shockwaves non-invasively at the level of injury
Device: ESWT
at low energy, shockwaves are applied non-invasively at the injury level and 5 segments up and down of the spinal cord paravertebrally left and right
Other Name: Extracorporeal shockwave therapy

Placebo Comparator: Placebo ESWT
Positioning of the therapy head at the injury level without application of shockwaves
Device: Placebo ESWT
the ESWT therapy head is positioned at the level of injury and is moved up and down identically as described in the Verum intervention group (ESWT) but without application of shockwaves. The sound which is normally produced by shockwave generation is played by high quality sound recordings in the same amount as in the Verum group




Primary Outcome Measures :
  1. Motor function [ Time Frame: 24 weeks ]
    Motor function of the lower limbs assessed by gait analysis tool (Lokomat (R))


Secondary Outcome Measures :
  1. Sensitivity and Motor function [ Time Frame: 24 weeks ]

    Assessment of levels by the ASIA score ASIA score - a neurologic assessment for patients with spinal cord injury developed by the American Spinal Injury Association.

    Examination includes the pin-prick discrimination assessment at 28 specific sensory locations bilaterally but also 10 muscles bilaterally.

    Sensory levels for each dermatome (nt...not testable, 0...absent sensation, 1...present sensation but impaired, 2...normal) Motor function of 5 upper extremity and 5 lower extremity key muscles (0...complete paralysis, 1...palpable or visible contraction, 2...active movement, full range of motion, gravity eliminated, 3...active movement, full range of motion, against gravity, 4...active movement, full range of motion, against gravity and provides some resistance, 5...active movement, full range of motion, against gravity and provides normal resistance, nt...not testable)


  2. Spasticity [ Time Frame: 24 weeks ]

    Evaluation of spasticity degree assessed by the Tardieu test (muscle resistance to passive movement at both slow and fast speed) 2 measurements are performed:

    1. Quality of muscle reaction
    2. Angle of muscle reaction 3 speed definitions:

    1) V1 is slow as possible 2) V2 speed of limb falling under gravity 3) V3 moving as fast as possible Quality of Muscle Reaction (scored 0-5); 0 is no resistance to passive ROM to 5 indicating joint is immobile (Some versions scored 0-4).


  3. Trunk control [ Time Frame: 24 weeks ]
    evaluation of trunk control by the modified functional reach test and Ott test

  4. Lung function [ Time Frame: 24 weeks ]
    Assessment of lung function by peak flow measurements

  5. Quality of life [ Time Frame: 24 weeks ]
    Assessed by the disability scale SCIM (spinal cord independence measure); Subscores include self-care (range von 0-20 points), respiration and sphincter management (range from 0-40), and mobility (range from 0-40); In total scale range from 0-100 (0 = total dependence, 100 = complete independence).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399968


Contacts
Contact: Wolfgang Schaden, MD +435939320100 wolfgang.schaden@auva.at
Contact: Rainer Mittermayr, MD +435939345000 Rainer.Mittermayr@auva.at

Locations
Austria
AUVA Rehabilitation Center Weisser Hof Recruiting
Klosterneuburg, Lower Austria, Austria, 3400
Contact: Karin Gstaltner, MD    +435939351000      
Principal Investigator: Josef Hufgard, MD         
AUVA Rehabilitation Center Tobelbad Recruiting
Haselsdorf, Styria, Austria, 8144
Contact: Renate Wildburger, MD    +435939353000      
Principal Investigator: Anja Grazer-Horacek, MD         
Sponsors and Collaborators
AUVA Trauma Center Meidling

Responsible Party: AUVA Trauma Center Meidling
ClinicalTrials.gov Identifier: NCT03399968     History of Changes
Other Study ID Numbers: ESWT_SCI/1.9-2014
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AUVA Trauma Center Meidling:
shockwave
ESWT

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries