Using shock wave therapy for acute spinal cord injuries
Official title: The Effect of Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury: A Two-arm Three-stage Adaptive, Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial
Run by Auva · NCT04474106 · Data updated 2026-11-12
This study is testing if shock wave therapy can help people with recent spinal cord injuries improve their movement and feeling compared to a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 246 (estimated) |
| Sponsor | Auva Academic / other |
| Drugs / interventions | radiation |
| Locations | 15 sites (Innsbruck, Tyrol and 14 other locations) |
| Status | Recruiting |
| Started | July 2, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 1, 2024 |
| Trial ID | NCT04474106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have sustained acute traumatic spinal injuries and can provide informed consent.
✕Probably not a fit
Patients with complete spinal cord transection or serious concomitant injuries that hinder neurological assessment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of extracorporeal shock wave therapy (ESWT) on patients with acute traumatic spinal cord injuries, focusing on both complete and incomplete lesions. The approach aims to address the primary mechanical damage and the subsequent secondary injury processes that occur after trauma. Patients who are awake and responsive will receive either the shock wave treatment or a placebo, with assessments made on their motor and sensory functions within six months post-injury. The study is part of a larger registry aimed at understanding spinal cord injuries better.
Why it matters
Potential benefit: If successful, this therapy could improve neurological recovery and functional outcomes for patients with acute spinal cord injuries.
How similar studies have gone: While the use of shock wave therapy is a novel approach in this context, similar studies have shown promise in other areas of rehabilitation and injury recovery.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with acute traumatic spinal injuries who are awake, responsive, and oriented at admission * Patients from the age of 18 years * Admission to hospital within 24 hours after injury * Written consent to participate in the study * Participation in the Austrian Spinal Cord Injury Study (ASCIS)-Registry (only for the Austrian hospitals) Exclusion Criteria: * Patients who cannot cooperate or are not capable to give consent to participate * Serious traumatic brain injuries that prevent accurate participation in study procedures and/or adequacy of informed consent Participation in other interventional clinical trials * Serious concomitant injuries that prevent the neurological initial assessment * Preexisting neurological conditions that affect the primary endpoint of the study and potentially mask or reduce the therapeutic effect of the ESWT application * High dose administration of corticosteroids * Complete spinal cord transection * Patients with pacemakers or implantable defibrillators * Patients who are using devices which are sensitive to electromagnetic radiation * (potential) Pregnancy * Patients with tumors * Patients with severe coagulation disorders
Where it's running
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Medical University Innsbruck
Innsbruck, Tyrol, Austria Recruiting -
Landeskarnkenhaus Feldkirch
Feldkirch, Austria Recruiting -
Unfallkrankenhaus Graz
Graz, Austria Recruiting -
Unfallkrankenhaus Klagenfurt
Klagenfurt, Austria Recruiting -
Unfallkrankenhaus Linz
Linz, Austria Recruiting -
Unfallkrankenhaus Salzburg
Salzburg, Austria Recruiting
Show 9 more locations
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Universitätsklinik Wien, AKH
Vienna, Austria Recruiting -
Unfallkrankenhaus Meidling
Vienna, Austria Recruiting -
Rehazentrum Bad Häring
Bad Häring, Austria Active not recruiting -
Rehazentrum Tobelbad
Graz, Austria Active not recruiting -
Rehazentrum Weißer Hof
Klosterneuburg, Austria Active not recruiting -
Universitätsklinik für Orthopädie und Traumatologie
Salzburg, Austria Withdrawn -
Unfallkrankenhaus St. Pölten
Sankt Pölten, Austria Withdrawn -
Unfallkrankenhaus Lorenz Böhler
Vienna, Austria Withdrawn -
SMZ Ost, Donauspital Abteilung für Unfallchirurgie
Vienna, Austria Not yet recruiting
Study contacts
- Principal investigator: Wolfgang Schaden, Dr. — Auva
- Study coordinator: Wolfgang Schaden, Dr
- Email: wolfgang.schaden@auva.at
- Phone: 0043 5 9393 20170
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Surgical treatment for spinal cord injuries using nerve grafts
This study is testing a new surgical method using nerve grafts to see if it can help people with recent spinal cord injuries recover better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.