Using shock wave therapy for acute spinal cord injuries
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Auva Academic / other |
| Drugs / interventions | radiation |
| Locations | 15 sites (Innsbruck, Tyrol and 14 other locations) |
| Trial ID | NCT04474106 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have sustained acute traumatic spinal injuries and can provide informed consent.
Not a fit: Patients with complete spinal cord transection or serious concomitant injuries that hinder neurological assessment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Innsbruck, Tyrol and 14 other locations
- Medical University Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
- Rehazentrum Bad Häring — Bad Häring, Austria (Active_not_recruiting)
- Landeskarnkenhaus Feldkirch — Feldkirch, Austria (Recruiting)
- Unfallkrankenhaus Graz — Graz, Austria (Recruiting)
- Rehazentrum Tobelbad — Graz, Austria (Active_not_recruiting)
- Unfallkrankenhaus Klagenfurt — Klagenfurt, Austria (Recruiting)
- Rehazentrum Weißer Hof — Klosterneuburg, Austria (Active_not_recruiting)
- Unfallkrankenhaus Linz — Linz, Austria (Recruiting)
- Unfallkrankenhaus Salzburg — Salzburg, Austria (Recruiting)
- Universitätsklinik für Orthopädie und Traumatologie — Salzburg, Austria (Withdrawn)
- Unfallkrankenhaus St. Pölten — Sankt Pölten, Austria (Withdrawn)
- Universitätsklinik Wien, AKH — Vienna, Austria (Recruiting)
- Unfallkrankenhaus Meidling — Vienna, Austria (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.