Skip to main content
OpenTrials
Completed

NCT Number: NCT06225024

Efficacy of Extracorporeal Shock Wave Therapy on Spasticity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity, Muscle Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University, Kayseri Medicine Faculty

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESWT

Device

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

Other names: device therapy

BoNT A

Drug

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

Other names: drug therapy

Primary outcomes

  1. Modified Ashworth Scale (MAS)

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

    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

    • 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
    • Increased muscle tone throughout the entire range of motion, but joints can be easily moved
    • Considerable increase in tone; passive movement is difficult
    • Affected parts are rigid in flexion and extension.

Secondary outcomes

  1. Brunnstrom Motor Recovery Stage (BMRS)

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

    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

Other outcomes

  1. Ankle ROM measurement

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

    Passive joint ROM of the affected ankle was calculated using a goniometer according to the neutral zero method.

  2. Clonus score (CS)

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

    The clonus felt during the examination is graded from 0 to 3. The study evaluated the clonus score by grading the clonus felt while passively moving the affected ankle from maximum plantar flexion to maximum dorsiflexion.

    The clonus scores were interpreted as 0= None, 1= Non-sustained, 2= Sustained, and 3=Spontaneous/Light touch-induced.

  3. Barthel Index (BI)

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

    BI is a detailed, objective, easy-to-administer, and comprehensible scale that assesses physical independence in activities of daily living and thoroughly evaluates all steps of activities of daily living. It was developed to assess the change in functional status in rehabilitation patients. BI consists of 10 main topics. Feeding, transfers from bed to wheelchair and back, grooming, toileting, bathing, mobility on level surfaces (using a wheelchair if appropriate), climbing up and downstairs, dressing, bowel care, and bladder care are questioned. A score of 0-20 indicates complete dependence; a score of 21-61 indicates severe dependence; a score of 62-90 indicates moderate dependence; a score of 91-99 indicates mild dependence; a score of 100 indicates complete independence.

  4. Heckmatt measurements with ultrasonography

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

    The echo intensity within the affected muscle group is assessed and scored with the help of ultrasonography. Echo intensity in the gastrocnemius muscle was visually evaluated in transverse view using a linear probe (Philips Clearvue 550) with an imaging frequency of 5-12 MHz in sonographic examination according to the Heckmatt scale; grade I was recorded as normal; grade II as increased muscle echo intensity with considerable bone echo; grade III as a significant increase in muscle echo intensity and decreased bone echo; grade IV as very high muscle echo intensity and complete loss of bone echo.

  5. Visual analog scale (VAS) pain assessment.

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

    A 10-centimeter line was drawn for pain, one end indicates no pain, and the other indicates severe pain. The patient was asked to mark his/her current condition on this line. The length of the distance from the end which indicates no pain to the point where the patient marks indicates the patient's pain

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Collaborators

  • Saglik Bilimleri Universitesi

Registry information

Official study title

Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) Following Botulinum Toxin Type A Injection on Post-Stroke Ankle Plantar Flexor Spasticity

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.