Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

Launched by KESSLER FOUNDATION · Jun 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called extracorporeal shockwave therapy (ESWT) to see if it can help reduce spasticity in people who have suffered a spinal cord injury (SCI). Spasticity is a condition that causes muscle stiffness and spasms, which can greatly affect daily life and independence. The researchers want to find out if ESWT, which is a non-invasive treatment that uses sound waves to stimulate the muscles, can be safe and effective for people dealing with the challenges of spasticity after SCI.

To participate in this trial, individuals must be at least 18 years old and have had a non-progressive traumatic spinal cord injury for over a year. They should also experience muscle stiffness in their legs. Participants will be randomly assigned to either receive the shockwave therapy or a placebo treatment that does not have any real effect. Throughout the study, participants will be asked to share their experiences with spasticity and how it affects their quality of life. The information gathered from this pilot study will help the researchers plan a larger trial to better understand the potential benefits of ESWT for people with spinal cord injuries.

Gender

ALL

Eligibility 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.