Using shockwave therapy to treat spasticity in spinal cord injury patients
Effect of Extracorporeal Shockwave Therapy on Spasticity in Chronic SCI: A Pilot Study
NA · Kessler Foundation · NCT05432999
This study is testing if shockwave therapy can help reduce muscle stiffness in adults with spinal cord injuries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kessler Foundation (other) |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT05432999 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of extracorporeal shockwave therapy to alleviate spasticity in individuals with spinal cord injuries. Spasticity is a common complication that can severely affect quality of life and functional independence. The study aims to enroll participants who are at least 18 years old and have experienced a non-progressive traumatic spinal cord injury for over a year. Participants will receive shockwave therapy targeting the gastrocnemius muscle to assess its effectiveness in reducing spasticity symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a non-progressive traumatic spinal cord injury and a modified Ashworth scale score of 2 or greater in the gastrocnemius muscle.
Not a fit: Patients with recent infections at the treatment site, severe coagulopathies, or those who have undergone recent surgical procedures of the lower extremity may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life and functional independence for patients suffering from spasticity due to spinal cord injuries.
How similar studies have performed: While there is limited data on the use of shockwave therapy for spasticity, similar approaches in treating other conditions have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years of age or older. 2. Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment. 3. MAS score of 2 or greater in the gastrocnemius of the treated limb. 4. Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).164 5. No change in antispasmodic medications within the past three months or intended changes over the course of the trial. 6. Participant is able and willing to comply with the protocol. Exclusion Criteria: 1. History of surgical procedures of the lower extremity. 2. Ankle contracture. 3. Sever, inflammatory arthritic diseases. 4. Thrombosis. 5. Anticoagulant medications. 6. Pregnancy. 7. Cancer. 8. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (RECRUITING)
Study contacts
- Study coordinator: Nathan Hogaboom, PhD
- Email: nhogaboom@kesslerfoundation.org
- Phone: 9733243584
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.
Conditions: Spinal Cord Injuries, Spasticity, Muscle, Spastic Paraplegia, Spastic Quadriplegia, Spastic Tetraplegia, Paraplegia, Tetraplegia, shockwave