Status:
RECRUITING
Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury
Lead Sponsor:
Kessler Foundation
Conditions:
Spinal Cord Injuries
Spasticity, Muscle
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spastici...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment.
- MAS score of 2 or greater in the gastrocnemius of the treated limb.
- 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
- No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
- Participant is able and willing to comply with the protocol.
Exclusion
- History of surgical procedures of the lower extremity.
- Ankle contracture.
- Sever, inflammatory arthritic diseases.
- Thrombosis.
- Anticoagulant medications.
- Pregnancy.
- Cancer.
- Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05432999
Start Date
September 1 2022
End Date
February 1 2026
Last Update
May 7 2025
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052