NCT06126523

Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients.

Effect of Extracorporeal Shock Wave Therapy Applied After Botulinum Toxin Injection on Ankle Plantar Flexor Spasticity in Stroke Patients: Placebo-controlled Double-blind Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Stroke is the second most common cause of death and the third most important cause of disability worldwide, with an annual death rate of 5.5 million. Spasticity is a common condition in stroke patients and has a negative impact on daily living activities. BTX-A has been successfully used in the treatment of spasticity in patients with stroke. ESWT is a physical therapy method applying high intensity pressure waves. ESWT has been increasingly used in the management of spasticity as a safe and effective method, but the literature about ESWT in spasticity is heterogeneous and the treatment protocols are not very clear about the number of applications. The aim of this study is to determine the effects of rESWT treatment on ankle plantar flexors spasticity applied after BTX-A injection.

Detailed description

In this double-blind randomized placebo-controlled trial, 45 patient (aged 18-75) diagnosed as stroke with appropriate criteria will be included. Patients who meet the inclusion criteria for the study will be seperated into three groups with the randomizer.org randomization program. Group I: A single session of rESWT will be applied on the same day after BTX-A injection. Group II: A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A injection. Group III: A single session of placebo rESWT will be applied after BTX-A injection. BTX-A injections to gastrocnemius and soleus muscles will be performed under ultrasonography guidance. rESWT will be applied to the injection points in gastrocnemius and soleus muscles. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. (Number of pulses: 1500 pulses, frequency: 6 Hz, Energy level/Pressure: 2.2 bar air pressure, duration: 12 minutes) Patients will be evaluated by the same researcher before treatment, 2 weeks after treatment, 1 month after treatment and 3 months after treatment. Patients will be evaluated using the Modified Ashworth Scale, Modified Tardieu Scale, Visual Analog Scale, 10 m walk test, Timed Up and Go Test, Timed Sit and Go Test, Barthel Activities of Daily Living Index, Functional Ambulation Scale, Brunnstrom Staging.

Conditions

• Stroke
• Spasticity as Sequela of Stroke

Interventions

Type	Name	Description
DEVICE	Radial Extracorporeal Shock Wave Therapy ONCE	rESWT application ONCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves.
DEVICE	Radial Extracorporeal Shock Wave Therapy TWİCE	rESWT application TWİCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A. Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves.
DEVICE	Radial Extracorporeal Shock Wave Therapy SHAM	Radial Extracorporeal Shock Wave Therapy- SHAM The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. Sham ESWT will be administered with the r-ESWT probe. The device will be switched on, the frequency, pressure and duration values will be set and then the device will be switched off and the probe will be kept in equal time with the active treatment, by playing a sound previously recorded during the real application.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-02-26
• Completion: 2024-03-01
• First posted: 2023-11-13
• Last updated: 2023-12-26

Locations

1 site across 1 country: Turkey (Türkiye)