Clinical trial NCT06126523: Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients.
Official title: Effect of Extracorporeal Shock Wave Therapy Applied After Botulinum Toxin Injection on Ankle Plantar Flexor Spasticity in Stroke Patients: Placebo-controlled Double-blind Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Spasticity as Sequela of Stroke
Keywords: spasticity
ESWT
Botulinum Toxin
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient Evaluation Form
timeFrame: BEFORE TREATMENT
measure: Modified Ashworth Scale (MAS)
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
measure: Modified Tardieu Scale (MTS)
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
measure: 10m walking test
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
measure: Timed Up and Go Test
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
measure: Timed sit and stand test
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
measure: Barthel Activities of Daily Living Index
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
measure: Functional Ambulation Scale
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
measure: Brunnstrom Staging
timeFrame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SaglikBilimleriU
Study officials:
References: