Efficacy of Extracorporeal Shock Wave Therapy on Spasticity

Kayseri City Hospital40 enrolled

Overview

Introduction: We aimed to compare the efficacy of Botulinum Toxin Type A(BoNT-A) injection and BoNT-A injection in combination with ESWT for post-stroke lower extremity ankle plantar flexor spasticity. Materials and Method: Patients with post-stroke ankle plantar flexor spasticity of 1 or more on the modified Ashworth Scale(MAS) were randomized into two groups. Group 1(n:20): BoNT-A was injected into the gastrocnemius muscle and conventional physical therapy exercises were performed. Group 2(n:20): ESWT was applied to the gastrocnemius muscle in addition to the treatments in group 1.

Group 1 (n:20): BoNT-A was injected into the affected gastrocnemius muscle under ultrasonography guidance at doses recommended by standard guidelines and appropriate for the patient (50 IU to the medial head, 25 IU to the lateral head). In addition, conventional physical therapy exercises (stretching exercises, range of motion (ROM) exercises, neurophysiologic exercises, and gait exercises) were applied to the patients five days a week for four weeks. Group 2 (n:20): In addition to the treatments (BoNT-A injection and exercise) in Group 1, one week after the injection, a total of 4 sessions (2 days a week) of ESWT (1000 impulses with an energy density of 0.1 mj/mm2, pressure of 2 bar, and frequency of 4 Hz) were applied to the medial and lateral heads of the gastrocnemius muscle. The patients in both groups underwent the following evaluations before treatment, at one month and three months after treatment by a treatment-blinded Physical Medicine and Rehabilitation (PMR) physician. Patients' age, sex, occupation, hemiplegic sides, and etiology of hemiplegia were recorded. Physical examination was performed, and examination findings were recorded. The presence of post-treatment pain, redness, tenderness, or other adverse findings were questioned. MAS, Brunnstrom Motor Recovery Stage(BMRS), ankle range of motion(ROM) measurement, clonus score(CS), Barthel Index(BI), Heckmatt measurements with ultrasonography, and visual analog scale(VAS) evaluations were performed on the patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Conditions

Stroke Spasticity, Muscle

Interventions

ESWTDEVICE

Extracorporeal shock wave therapy (ESWT) is a treatment method based on high-intensity sound waves focusing on the desired body area to provide treatment. ESWT is a safe, non-invasive, alternative treatment for spasticity in patients with stroke, cerebral palsy, and multiple sclerosis and does not cause muscle weakness or adverse effects

BoNT ADRUG

BoNT-A is widely recognized as the benchmark for enhancing the effectiveness of spasticity management

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Being diagnosed with stroke according to the definition of the World Health Organization in 1989 * Having a stroke confirmed by computed tomography (CT) and magnetic resonance imaging (MRI) * Being aged over 18 years * Having a MAS score of 1 and above for gastrocnemius, the plantar flexor muscle of the ankle * Having a stable general condition after a stroke * Giving consent to participate in the study. Exclusion criteria: * Having a fixed contracture in the ankle * Having no spasticity in the soleus, the plantar flexor muscle of the ankle * Previous antispastic surgery performed on the area * Change in antispastic drug use in the last six months, if any * Injection of BoNT-A, alcohol, phenol, or any other substance into the area in the last six months * Active infection or cancer at the application site * Having a cardiac pacemaker * Having bleeding diathesis * Having vascular complaints such as deep vein thrombosis, venous stasis, phlebitis, arterial disease * Being pregnant * Having neuromuscular junction disease or motor neuron disease * Having a known allergy to BoNT-A * 12\. Active use of aminoglycosides or other antibiotic groups.

Locations (1)

Health Sciences University, Kayseri Medicine Faculty

Kayseri, Kocasinan, Turkey (Türkiye)

Outcomes

Primary Outcomes

Modified Ashworth Scale (MAS)

This scale is used to evaluate the severity of spasticity. MAS is based on a subjective evaluation of the resistance felt during the examination. 0: No tone increase 1. Slight increase in tone characterized by a catch and release or minimal resistance at the end of the range of motion 1+: Slight increase in muscle tone with minimal resistance throughout less than half of the range of motion 2. Increased muscle tone throughout the entire range of motion, but joints can be easily moved 3. Considerable increase in tone; passive movement is difficult 4. Affected parts are rigid in flexion and extension.

Time frame: at baseline, at one month and three months after treatment

Secondary Outcomes

Brunnstrom Motor Recovery Stage (BMRS)

It is a motor function assessment scale to evaluate the motor development of hemiplegic patients. According to Brunnstrom, there are six stages in the recovery process of hemiplegic patients, and the upper extremity, lower extremity, and hands are individually evaluated. A higher BMRS indicates better motor development

Time frame: at baseline, at one month and three months after treatment

Data from ClinicalTrials.gov

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