Efficacy of Extracorporeal Shock Wave Therapy on Spasticity

NCT06225024 | Completed

• 1 other identifier: University of Health Sciences
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Spasticity, Muscle

Keywords

Botulinum Toxin A; ESWT; Stroke; Spasticity; Modified Ashworth Scale; Heckmatt Scale

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline, at one month and three months after treatment

Secondary Outcomes (1)

• Brunnstrom Motor Recovery Stage (BMRS)

  at baseline, at one month and three months after treatment

Other Outcomes (5)

• Ankle ROM measurement

  at baseline, at one month and three months after treatment

• Clonus score (CS)

  at baseline, at one month and three months after treatment

• Barthel Index (BI)

  at baseline, at one month and three months after treatment

Study Arms (2)

BoNT-A

ACTIVE COMPARATOR

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 and ESWT

EXPERIMENTAL

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.

Device: ESWT; Drug: BoNT A

Interventions

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

Also known as: device therapy

BoNT-A and ESWT

BoNT A DRUG

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

Also known as: drug therapy

BoNT-A; BoNT-A and ESWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \. Active use of aminoglycosides or other antibiotic groups.

Sponsors & Collaborators

• Kayseri City Hospital: lead
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 33906450 BACKGROUND

• 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.

  PMID: 34682846 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Cardiac Resynchronization Therapy Devices; incobotulinumtoxinA; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pacemaker, Artificial; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Therapeutics

Study Officials

• HAVVA TALAY ÇALIŞ

  KAYSERİ CITY HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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: 1. Modified Ashworth Scale (MAS) 2. Brunnstrom Motor Recovery Stage (BMRS) 3. Ankle range of motion (2) measurement 4. Clonus score (CS) 5. Barthel Index (BI) 6. Heckmatt measurements with ultrasonography 7. Visual analog scale (VAS) pain assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Randomized Controlled

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 25, 2024
• Study Start: March 15, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)