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

Saglik Bilimleri Universitesi

Status: Invitation-only

Conditions: Stroke; Spasticity as Sequela of Stroke

Treatments: Device: Radial Extracorporeal Shock Wave Therapy SHAM; Device: Radial Extracorporeal Shock Wave Therapy ONCE; Device: Radial Extracorporeal Shock Wave Therapy TWİCE

Study type: Interventional

Funder types: Other

Identifiers

NCT06126523

ZSAYNELI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having an ischemic or hemorrhagic stroke, in subacute or chronic phase,
• Patients with ankle plantar flexor spasticity MAS score > 1 and patients who received BTX-A injection due to spasticity
• Stroke history of at least 3 months

Exclusion criteria

• History of neuromuscular disease
• Compared to the unaffected side; More than 50% reduction in dorsiflexion range of motion of the affected side
• Dynamic ankle contracture
• Affected side lower extremity surgery in the last 12 months
• Having Botox or phenol application to the affected gastrocnemius in the last 3 months
• Change in the dose of antispastic medication used in the last 3 months
• Infection/wound in the affected lower extremity
• Contraindications for ESWT (pregnancy, cancer, bleeding disorders, inflammatory disease, pacemakers or other electronic implants).
• Significant muscle atrophy or fibrosis of the target muscle (Heckmatt scale III and IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

ESWT once

Active Comparator group

Description:

A single session of rESWT will be applied on the same day after BTX-A injection.

Treatment:

Device: Radial Extracorporeal Shock Wave Therapy ONCE

ESWT twice

Active Comparator group

Description:

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.

Treatment:

Device: Radial Extracorporeal Shock Wave Therapy ONCE

Device: Radial Extracorporeal Shock Wave Therapy TWİCE

Sham ESWT

Sham Comparator group

Description:

A single session of placebo rESWT will be applied after BTX-A injection.

Treatment:

Device: Radial Extracorporeal Shock Wave Therapy SHAM