Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity

Pamukkale University

Status: Enrolling

Conditions: Extracorporal Shockwave Therapy (ESWT); Stroke; Spastic Hemiplegia

Treatments: Other: Conventional rehabilitation; Device: Radial Extracorporeal Shock Wave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07119801

PamukkaleU.ftr-MGAkıncı-001

Details and patient eligibility

About

This research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients.

Spasticity, a common complication after a stroke, causes muscle stiffness, pain, and functional limitation, leading to increased healthcare costs and a lower quality of life. Current treatments like medication and injections have significant drawbacks, such as side effects and high costs, creating a need for new, non-invasive, and effective methods.

The study highlights that traditional methods for assessing spasticity, like the Modified Ashworth Scale (MAS), are subjective. It proposes using objective, non-invasive ultrasound techniques-specifically strain elastography (to measure muscle stiffness) and echogenicity (to assess muscle tissue quality)-for a more reliable evaluation.

The primary goal of this research is to be the first to investigate the short- and long-term effects of ESWT on the FCR and FCU muscles using these objective ultrasound measures alongside traditional clinical scales. The findings are expected to help standardize ESWT treatment protocols and promote the use of objective ultrasound data for the management and follow-up of post-stroke spasticity.

Enrollment: 32 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 35 and 65 years.
• First-ever stroke episode confirmed by MRI and/or CT scan.
• Clinical diagnosis of hemiplegia.
• More than 6 months post-stroke.
• A Modified Ashworth Scale (MAS) score between 1 and 3 for wrist flexor spasticity.

Exclusion criteria

• History of more than one stroke episode
• Stroke onset more than ten years ago
• Stroke onset less than 6 months ago
• Age over 65 (to limit the effects of aging on muscle structure)
• Contraindications for ESWT (e.g., cancer, local tumor or active infection in the treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants)
• Severe aphasia or serious communication problems
• Presence of fixed contracture in the wrist
• Patients who have received botulinum toxin or phenol nerve block injections within the last 6 months
• Medically unstable patients (e.g., uncontrolled hypertension, diabetes mellitus, or severe cardiac, hepatic, or renal disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Conventional group

Active Comparator group

Description:

This group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs.

Treatment:

Other: Conventional rehabilitation

radial ESWT (rESWT) plus conventional rehabilitation group

Experimental group

Description:

The rESWT will be applied to the Flexor Carpi Ulnaris (FCU) and Flexor Carpi Radialis (FCR) muscles twice a week for four weeks, totaling eight sessions. The application site will be the midpoint of the most prominent part of each muscle. For each muscle, a 15 mm applicator head will be used to deliver 2000 impulses at a frequency of 5 Hz and an intensity of 60 mJ (1 bar), corresponding to an energy flux density of 0.340 mJ/mm². Additionally, this group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs.

Treatment:

Device: Radial Extracorporeal Shock Wave Therapy

Other: Conventional rehabilitation