Clinical trial NCT06225024: Efficacy of Extracorporeal Shock Wave Therapy on Spasticity
Official title: Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) Following Botulinum Toxin Type A Injection on Post-Stroke Ankle Plantar Flexor Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity, Muscle
Keywords: Botulinum Toxin A
ESWT
Stroke
Spasticity
Modified Ashworth Scale
Heckmatt Scale
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2024-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: at baseline, at one month and three months after treatment
Secondary outcomes:
measure: Brunnstrom Motor Recovery Stage (BMRS)
timeFrame: at baseline, at one month and three months after treatment
Other outcomes:
measure: Ankle ROM measurement
timeFrame: at baseline, at one month and three months after treatment
measure: Clonus score (CS)
timeFrame: at baseline, at one month and three months after treatment
measure: Barthel Index (BI)
timeFrame: at baseline, at one month and three months after treatment
measure: Heckmatt measurements with ultrasonography
timeFrame: at baseline, at one month and three months after treatment
measure: Visual analog scale (VAS) pain assessment.
timeFrame: at baseline, at one month and three months after treatment
Locations:
city: Kayseri
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty
state: Kocasinan
Study officials:
affiliation: KAYSERİ CITY HOSPITAL
name: HAVVA TALAY ÇALIŞ
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.