Efficacy of Shock Wave Therapy in Post-Stroke Muscle Spasticity Management

NCT ID: NCT06815328

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-04-30

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.

Conditions

Stroke; Spasticity; Post-stroke; Muscle Hypertonia; Neurological Disorders; Physiotherapy

Study Design

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

Study Groups

Experimental: Shock Wave Therapy (SWT)

Participants in this arm will receive Shock Wave Therapy applied to spastic muscle groups identified during the baseline assessment. The therapy will be delivered using a focused SWT device with standardized parameters (e.g., frequency, energy level, and duration). Each session will last approximately 30 minutes and will be administered once a week for 8 weeks. The intervention targets neuromuscular modulation to reduce spasticity and improve joint mobility.

Group Type: EXPERIMENTAL

Shock Wave Therapy (SWT)

Intervention Type: OTHER

Focused SWT sessions targeting spastic muscle groups. Parameters include standardized frequency, energy level, and session duration (30 minutes per session, once weekly for 8 weeks). This therapy aims to reduce muscle spasticity, improve joint mobility, and enhance quality of life.

Standard care consisting of physical therapy sessions (e.g., stretching, mobility exercises) and/or prescribed medications for spasticity management. The therapy follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention.

Conventional Therapy

Participants in this arm will receive standard care for post-stroke spasticity, which may include physical therapy sessions focused on stretching, strengthening, and mobility exercises, alongside medications if prescribed (e.g., muscle relaxants). The therapy will follow current clinical guidelines and will be administered with the same frequency and duration (once a week for 8 weeks) to ensure comparability with the experimental arm.

Group Type: ACTIVE_COMPARATOR

Active Comparator - Conventional Therapy

Intervention Type: OTHER

Standard care consisting of physical therapy sessions (stretching, mobility exercises) and/or prescribed medications for spasticity management.

Follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention.

Interventions

Shock Wave Therapy (SWT)

Focused SWT sessions targeting spastic muscle groups. Parameters include standardized frequency, energy level, and session duration (30 minutes per session, once weekly for 8 weeks). This therapy aims to reduce muscle spasticity, improve joint mobility, and enhance quality of life.

Standard care consisting of physical therapy sessions (e.g., stretching, mobility exercises) and/or prescribed medications for spasticity management. The therapy follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention.

Intervention Type: OTHER

Active Comparator - Conventional Therapy

Standard care consisting of physical therapy sessions (stretching, mobility exercises) and/or prescribed medications for spasticity management.

Follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oviedo

OTHER

Sponsor Role: lead

Responsible Party

Maria Blanco Diaz

Professor and Researcher, Department of Surgery and Medical-Surgical Specialties, University of Oviedo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Oviedo

Oviedo, Principality of Asturias, Spain

Countries

Spain

Central Contacts

María Blanco Díaz, PhD.

Role: CONTACT

blancomaria@uniovi.es

+34667681858

Facility Contacts

María Blanco Díaz, PhD.

Role: primary

blancomaria@uniovi.es

+34667681858

Other Identifiers

Universidad de Oviedo

Identifier Type: -

Identifier Source: org_study_id