Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
A legfontosabb adatok
- Hol
- West Orange (Egyesült Államok)A helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Kessler FoundationWest Orange, Egyesült ÁllamokContact: Shalaka Paranjpe, MSRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Kessler Foundation
- Azonosító
- NCT07894991
- A regiszteradat frissítve
- 2026. november 4.
- Eredeti leírás
Spasticity is a common consequence of spinal cord injury and can have a profound impact on quality of life. The goal of this study is to learn if an intervention called focused extracorporeal shockwave therapy can enhance the effectiveness of injections received for spasticity, such as Botox. The main questions this study seeks to answer are whether shockwave therapy and toxin injection 1) can improve spasticity symptoms greater than toxin injection alone, and 2) change the structure of the injected muscles. Researchers will compare the group who receives both shockwave therapy and toxin injection to a group who receives only toxin injection. Participants will be asked to visit the clinic five times over the span of three months. The first three visits will occur on three consecutive weeks, during which participants will receive shockwave therapy or the sham therapy. The final two visits will occur four and eight weeks later, during which participants will be asked a series of questions about their spasticity and have ultrasounds and MRIs collected of their leg muscles.A teljes eredeti leírásKevesebb
Randomized, Sham-controlled Trial to Investigate Extracorporeal Shockwave Therapy as an Adjunctive Treatment for Spasticity Secondary to Spinal Cord Injury
Spasticity is a common consequence of spinal cord injury and can have a profound impact on quality of life. The goal of this study is to learn if an intervention called focused extracorporeal shockwave therapy can enhance the effectiveness of injections received for spasticity, such as Botox. The main questions this study seeks to answer are whether shockwave therapy and toxin injection 1) can improve spasticity symptoms greater than toxin injection alone, and 2) change the structure of the injected muscles. Researchers will compare the group who receives both shockwave therapy and toxin injection to a group who receives only toxin injection. Participants will be asked to visit the clinic five times over the span of three months. The first three visits will occur on three consecutive weeks, during which participants will receive shockwave therapy or the sham therapy. The final two visits will occur four and eight weeks later, during which participants will be asked a series of questions about their spasticity and have ultrasounds and MRIs collected of their leg muscles.
Bevonási feltételek: Women and men, age 18 years and older; Non-progressive SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to enrollment; Ankle flexor modified Ashworth scale (MAS) of between 1+ and 3, inclusive; No contraindication to f-ESWT, including current or recent infection at the treatment site and severe coagulopathies; No change in antispasmodic medications within the past 3 months or intended changes during the trial; currently being treated with BoNT in the plantar flexor muscles.
Kizáró feltételek: Anticoagulant medication; MRI contraindications (e.g. claustrophobia, ferromagnetic implants or debris); History of lower limb surgical procedures; Severe, inflammatory arthritic diseases; Thrombosis; Cancer; Ankle contracture; Pregnancy; Recent (12 months) local phenol/alcohol injection.