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Spinal Cord InjuriesNCT03399968

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

A study testing ESWT in people with Spinal Cord Injuries, run by AUVA Trauma Center Meidling at 2 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
ESWT
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
2 sitesAustria
Study dates
26 Mar 2015to 31 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Wolfgang Schaden, MD contact

+435939320100

wolfgang.schaden@auva.at

Rainer Mittermayr, MD contact

+435939345000

Rainer.Mittermayr@auva.at

Austria2 sites, 2 recruiting

  • AUVA Rehabilitation Center Tobelbad

    Haselsdorf, Styria, 8144

    Renate Wildburger, MD, +435939353000

    Anja Grazer-Horacek, MD

    Recruiting

  • AUVA Rehabilitation Center Weisser Hof

    Klosterneuburg, Lower Austria, 3400

    Karin Gstaltner, MD, +435939351000

    Josef Hufgard, MD

    Recruiting

Other trials in Austria

About this study

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.

Being tested
ESWT, Placebo ESWT
Keywords
shockwave, ESWT
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESWTDevice

    Also called Extracorporeal shockwave therapy

    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

  • Placebo ESWTDevice

    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

Study groups in NCT03399968
Study groupRoleWhat they receive
ESWTExperimentalApplication of shockwaves non-invasively at the level of injury
Receives: Device: ESWT
Placebo ESWTPlacebo comparatorPositioning of the therapy head at the injury level without application of shockwaves
Receives: Device: Placebo ESWT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motor function

    Motor function of the lower limbs assessed by gait analysis tool (Lokomat (R))

    Measured: 24 weeks

Secondary outcomes (5)

  1. Sensitivity and Motor function

    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)

    Measured: 24 weeks

  2. Spasticity

    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:
    3. 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).

    Measured: 24 weeks

  3. Trunk control

    evaluation of trunk control by the modified functional reach test and Ott test

    Measured: 24 weeks

  4. Lung function

    Assessment of lung function by peak flow measurements

    Measured: 24 weeks

  5. Quality of life

    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).

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start26 Mar 2015
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 May 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective randomized controlled double blinded clinical intervention study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03399968
Sponsor's protocol ID
ESWT_SCI/1.9-2014
Status last verified
Jul 2019
First submitted
9 Jan 2018
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ESWT in people with Spinal Cord Injuries, run by AUVA Trauma Center Meidling at 2 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wolfgang Schaden, MD (+435939320100, wolfgang.schaden@auva.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor function (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03399968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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