Efficacy of Extracorporeal Shock Wave Therapy on Spasticity

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

Study Overview

• Status: Completed
• Conditions: Stroke; Spasticity, Muscle
• Intervention / Treatment: Drug: BoNT A; Device: ESWT

Detailed Description

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kocasinan
    • Kayseri, Kocasinan, Turkey, 38080
      • Health Sciences University, Kayseri Medicine Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BoNT-A; 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.	Drug: BoNT A; BoNT-A is widely recognized as the benchmark for enhancing the effectiveness of spasticity management; Other Names: drug therapy
Experimental: BoNT-A and ESWT; 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.	Drug: BoNT A; BoNT-A is widely recognized as the benchmark for enhancing the effectiveness of spasticity management; Other Names: drug therapy; Device: ESWT; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; 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.	at baseline, at one month and three months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline, at one month and three months after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle ROM measurement	Passive joint ROM of the affected ankle was calculated using a goniometer according to the neutral zero method.	at baseline, at one month and three months after treatment
Clonus score (CS)	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.	at baseline, at one month and three months after treatment
Barthel Index (BI)	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.	at baseline, at one month and three months after treatment
Heckmatt measurements with ultrasonography	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.	at baseline, at one month and three months after treatment
Visual analog scale (VAS) pain assessment.	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	at baseline, at one month and three months after treatment

Collaborators and Investigators

• Sponsor: Kayseri City Hospital
• Collaborators: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: HAVVA TALAY ÇALIŞ, Kayseri City Hospital

Publications and helpful links

General Publications

• Yoldas Aslan S, Kutlay S, Dusunceli Atman E, Elhan AH, Gok H, Kucukdeveci AA. Does extracorporeal shock wave therapy decrease spasticity of ankle plantar flexor muscles in patients with stroke: A randomized controlled trial. Clin Rehabil. 2021 Oct;35(10):1442-1453. doi: 10.1177/02692155211011320. Epub 2021 Apr 28.
• Yang E, Lew HL, Ozcakar L, Wu CH. Recent Advances in the Treatment of Spasticity: Extracorporeal Shock Wave Therapy. J Clin Med. 2021 Oct 14;10(20):4723. doi: 10.3390/jcm10204723.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Botulinum Toxin A; Spasticity; ESWT; Modified Ashworth Scale; Heckmatt Scale
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: University of Health Sciences

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No