Clinical trial NCT06815328: Efficacy of Shock Wave Therapy in Post-Stroke Muscle Spasticity Management
Official title: Efficacy of Shock Wave Therapy in Patients with Muscle Spasticity After a Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Spasticity
Post-stroke
Muscle Hypertonia
Neurological Disorders
Physiotherapy
Keywords: Shock Wave Therapy
Post-Stroke Spasticity
Non-Invasive Therapy
Quality of Life
Neurological physical therapy
Muscle Hypertonia Treatment
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of shock wave therapy (SWT) in reducing muscle spasticity in patients who have suffered a stroke. The main questions it aims to answer are:

Does SWT reduce muscle tone and improve joint range of motion in post-stroke patients with spasticity? Does SWT improve the quality of life for these patients? What side effects, if any, occur during or after SWT? Researchers will compare SWT to conventional spasticity treatments to determine its effectiveness and potential advantages.

Participants will:

Undergo SWT sessions as part of their rehabilitation protocol over a period of 8 weeks.

Attend follow-up visits to assess muscle tone, joint mobility, and overall functional improvement.

Complete quality-of-life questionnaires to measure the therapy's impact on daily living.

Detailed description: This study aims to assess the efficacy and safety of Shock Wave Therapy (SWT) as a non-invasive treatment for muscle spasticity in post-stroke patients. Muscle spasticity is a major complication in neurorehabilitation, affecting mobility, functionality, and quality of life. Conventional treatments, including physical therapy, oral medications, and botulinum toxin injections, have limitations such as variable efficacy, side effects, and accessibility issues. SWT has gained interest as a potential alternative, but high-quality evidence regarding its effectiveness and safety in this population remains scarce.

Study Design and Rationale The study is designed as a prospective, randomized controlled trial (RCT) comparing SWT with conventional treatment approaches. SWT delivers mechanical acoustic waves to targeted spastic muscles, aiming to reduce hypertonicity and neuromuscular dysfunction. The hypothesized mechanism of action involves neuromuscular modulation, local tissue repair promotion, and increased vascularization, which may improve muscle tone, functional mobility, and overall patient outcomes.

Participants will undergo weekly SWT sessions for 8 weeks, each lasting approximately 30 minutes. Treatment will be applied to specific muscle groups, such as the elbow flexors, wrist flexors, or calf muscles, based on baseline assessments. The frequency, intensity, and duration of SWT will follow current clinical guidelines.

The control group will receive standard care, which may include physical therapy techniques such as stretching, therapeutic exercises, and pharmacological management as per clinical indication. The study will implement a blinded assessment process, where outcome evaluators will not be aware of group allocation.

Technical Aspects of SWT Application The SWT intervention will be conducted using a focused or radial shock wave device, applying preset intensity levels tailored to spastic muscle groups. The wave frequency and energy flux density will be determined based on prior research in musculoskeletal rehabilitation. SWT will be delivered at specific treatment points over affected muscles, with adjustments as necessary according to patient response and tolerability.

Data Collection and Monitoring Data will be collected at baseline, mid-treatment (week 4), and post-treatment (week 8) using standardized clinical assessment tools. The study will also monitor for adverse events, including pain, bruising, or transient increases in spasticity, to establish a safety profile for SWT in this population.

Potential Clinical Impact If SWT demonstrates clinically significant benefits, this study could support its integration into routine post-stroke rehabilitation protocols. The findings may provide guidance for rehabilitation professionals, contribute to cost-effective management strategies, and inform clinical decision-making regarding spasticity treatment.

Ethical Compliance This study adheres to the principles of the Declaration of Helsinki and has been submitted for approval to the appropriate institutional review boards. Participants will provide written informed consent before enrollment. All collected data will be handled following confidentiality and ethical guidelines.

Eligibility criteria: "Inclusion Criteria":

* Adults aged 18 years or older.
* Confirmed diagnosis of stroke (ischemic or hemorrhagic) at least 6 months prior to enrollment.
* Clinically diagnosed muscle spasticity, measured by the Modified Ashworth Scale (MAS), with a score of 0 to 3.
* Stable medical condition that permits participation in the intervention.
* No significant changes in spasticity-related treatment for at least 3 months prior to the study.
* Ability to provide written informed consent to participate in the study.
* Ability to attend weekly sessions and follow-up visits as required.

"Exclusion Criteria":

* Severe spasticity or contractures unresponsive to prior treatments.
* Contraindications to Shock Wave Therapy, including:
* Local infections in the treatment area.
* Known or suspected malignancy near the treatment site.
* Severe bleeding disorders or anticoagulation therapy.
* Pregnancy.
* Neurological conditions other than stroke that could interfere with study outcomes (e.g., Parkinson's disease, multiple sclerosis).
* Recent treatments that might interfere with spasticity assessment, including:
* Injections of botulinum toxin within the past 6 months.
* Recent surgery or other interventions targeting spasticity.
* Cognitive impairment or other conditions preventing the participant from following instructions or completing study tasks.
* Severe cardiovascular, renal, or hepatic disease that might complicate therapy or participation.
* Inability to commit to follow-up visits or complete the intervention protocol due to logistical, mobility, or health-related issues.

Primary outcomes:
measure: Change in Muscle Spasticity
timeFrame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Secondary outcomes:
measure: Change in Joint Range of Motion
timeFrame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
measure: Change in Quality of Life
timeFrame: Baseline and at 12 weeks (follow-up).
measure: Grip Strength
timeFrame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
measure: Incidence of Treatment-Related Adverse Events
timeFrame: Throughout the study period (12 weeks).
measure: Walking Speed
timeFrame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
References: