Efficacy of Extracorporeal Shock Wave Therapy on Spasticity

NCT ID: NCT06225024

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-06-15

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.

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.

Conditions

Stroke; Spasticity, Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

BoNT A

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

ESWT

Intervention Type: 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

BoNT A

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DEVICE

BoNT A

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

Intervention Type: DRUG

Other Intervention Names

device therapy; drug therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: collaborator

Kayseri City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Havva Talay Çalış

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HAVVA TALAY ÇALIŞ

Role: PRINCIPAL_INVESTIGATOR

KAYSERİ CITY HOSPITAL

Locations

Health Sciences University, Kayseri Medicine Faculty

Kayseri, Kocasinan, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 33906450 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34682846 (View on PubMed)

Other Identifiers

University of Health Sciences

Identifier Type: -

Identifier Source: org_study_id