Efficacy of Extracorporeal Shock Wave Therapy on Spasticity

K

Kayseri City Hospital

Status

Completed

Conditions

Spasticity, Muscle
Stroke

Treatments

Device: ESWT
Drug: BoNT A

Study type

Interventional

Funder types

Other

Identifiers

NCT06225024
University of Health Sciences

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
    1. Active use of aminoglycosides or other antibiotic groups.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

BoNT-A
Active Comparator group
Description:
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.
Treatment:
Drug: BoNT A
BoNT-A and ESWT
Experimental group
Description:
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.
Treatment:
Drug: BoNT A
Device: ESWT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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