Radiofrequency vs. Ultrasound Therapy for Shoulder Joint in Stroke Patients: A Comparative Clinical Trial

NCT ID: NCT07131943

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-28
• Study Completion Date: 2025-11-12

Brief Summary

The purpose of the current study is to:

Compare between radiofrequency (TECAR) therapy and ultrasound on Shoulder Pain, Range of Motion and Functional Outcome in Patients with stroke.

Detailed Description

Stroke is the third leading cause of death worldwide and a major contributor to long-term disability, particularly affecting upper limb function in about 70% of survivors. Among post-stroke complications, hemiplegic shoulder pain (HSP) is notably challenging, affecting 30-65% of patients and often resulting from structural injuries, poor posture, or conditions like rotator cuff impingement and shoulder-hand syndrome. HSP is linked to reduced arm function, depression, and diminished quality of life. Therapeutic approaches such as TECAR therapy and therapeutic ultrasound aim to alleviate pain and promote tissue healing through deep heat and mechanical effects. Assessment tools like the algometer, Numerical Rating Scale (NRS), digital goniometer, and the Shoulder Pain and Disability Index (SPADI)-including its validated Arabic version-are reliable methods for evaluating pain, joint mobility, and functional disability in stroke patients.

Conditions

Stroke ( 3 Months After Onset); Stroke in Patients: New Tool to Evaluate the Impact in Their Life

Study Design

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

Study Groups

Group (GI)= 15 will be treated by Radiofrequency TECAR Therapy

Group (GI) will be treated by Radiofrequency TECAR Therapy on shoulder joint as well as Designed Physical Therapy Program

Group Type: EXPERIMENTAL

Radiofrequency

Intervention Type: DEVICE

Radiofrequency (TECAR) therapy is a non-invasive, non-ablative treatment that uses electromagnetic energy to generate endogenous heat, promoting increased blood flow and tissue healing in both superficial and deep tissues. With a long wavelength and low frequency (300 KHz to 1 MHz), it can penetrate deeply into muscles, tendons, and bones, making it suitable even in acute conditions. TECAR operates in two modes: capacitive (targeting soft tissues rich in electrolytes) and resistive (targeting high-resistance tissues like bones and tendons). The therapy stimulates natural repair processes by inducing ion flow and micro-hyperemia, leading to the release of endorphins and cortisone, which help reduce pain, inflammation, and edema, while enhancing immune response and tissue regeneration.

Group (GII)= 15 will be treated by Ultrasound Therapy

Group (GII) will be treated by Ultrasound Therapy on shoulder joint as well as Designed Physical Therapy Program

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: DEVICE

The ultrasound waves accelerate healing, increasing local vascularity and improving several other characteristics, including energy absorption capacity and maximum rupture resistance tension, increased collagen synthesis, fibroblast proliferation, release of growth factors stimulated by mast cell degranulation and improved response of platelets and macrophages anticipating the proliferative and remodeling phase. 1-MHz continuous ultrasound, with a half-value depth of approximately 2.3 cm, is frequently used to treat deep tissues that are approximately 2.3 to 5 cm deep.

Group (GIII)= 15 will be treated by Designed Physical Therapy Program,

Group (GIII) will be treated by Designed Physical Therapy Program, all outcomes' measures will be assessed pre and post treatment.

Group Type: EXPERIMENTAL

The designed physical therapy program

Intervention Type: OTHER

The designed physical therapy program focuses on improving upper limb mobility and stability through a structured set of exercises targeting the shoulder joint. It includes prolonged stretching performed in a seated position to extend the thumb, fingers, wrist, elbow, and shoulder, along with scapular mobilization in side-lying and stretching of internal rotators in a supine position. The stretching progression begins with external rotation at 45° abduction and advances to 90° abduction and full reach toward the ground if pain-free. Joint stabilization exercises involve resistance band movements in various shoulder and elbow positions, including controlled abduction, flexion, scapular movements, and external rotation, all aimed at enhancing joint control and muscular coordination.

Interventions

Radiofrequency

Radiofrequency (TECAR) therapy is a non-invasive, non-ablative treatment that uses electromagnetic energy to generate endogenous heat, promoting increased blood flow and tissue healing in both superficial and deep tissues. With a long wavelength and low frequency (300 KHz to 1 MHz), it can penetrate deeply into muscles, tendons, and bones, making it suitable even in acute conditions. TECAR operates in two modes: capacitive (targeting soft tissues rich in electrolytes) and resistive (targeting high-resistance tissues like bones and tendons). The therapy stimulates natural repair processes by inducing ion flow and micro-hyperemia, leading to the release of endorphins and cortisone, which help reduce pain, inflammation, and edema, while enhancing immune response and tissue regeneration.

Intervention Type: DEVICE

Ultrasound

The ultrasound waves accelerate healing, increasing local vascularity and improving several other characteristics, including energy absorption capacity and maximum rupture resistance tension, increased collagen synthesis, fibroblast proliferation, release of growth factors stimulated by mast cell degranulation and improved response of platelets and macrophages anticipating the proliferative and remodeling phase. 1-MHz continuous ultrasound, with a half-value depth of approximately 2.3 cm, is frequently used to treat deep tissues that are approximately 2.3 to 5 cm deep.

Intervention Type: DEVICE

The designed physical therapy program

The designed physical therapy program focuses on improving upper limb mobility and stability through a structured set of exercises targeting the shoulder joint. It includes prolonged stretching performed in a seated position to extend the thumb, fingers, wrist, elbow, and shoulder, along with scapular mobilization in side-lying and stretching of internal rotators in a supine position. The stretching progression begins with external rotation at 45° abduction and advances to 90° abduction and full reach toward the ground if pain-free. Joint stabilization exercises involve resistance band movements in various shoulder and elbow positions, including controlled abduction, flexion, scapular movements, and external rotation, all aimed at enhancing joint control and muscular coordination.

Intervention Type: OTHER

Other Intervention Names

US; Treatment Exercises

Eligibility Criteria

Inclusion Criteria

• Fourty-five hemiplegic patients with shoulder pain post- stroke from both sexes will participate in this study.
• The patients will be older than 18 years old (30-60 years old)
• The presence of sub-acute shoulder pain (more than 3 months).
• Sub-acute stroke survivors (3 months post-stroke).
• score of 1|1+ points on the Modified Ashworth Scale (MAS) on shoulder joint.
• Stage 2 or above according to Brunnstrom function assessment of shoulder joint
• All conducted patients experienced a single stroke during the last 3 months with cognitive capacity that will enable them to comprehend and follow the instructions (Mini-Mental Scale score > 24).

Exclusion Criteria

• The following patients will be excluded from the study patients with:

• Bilateral adhesive capsulitis
• Systemic diseases such as rheumatoid arthritis, malignancies, heart diseases, infections, coagulation disorders, full rotator cuff tears
• A history of recent shoulder surgery, neurological problems involving the upper extremity, shoulder joint osteoarthritis
• Upper extremity fractures, cervical radiculopathy
• Impaired sensation, having a heart pacemaker, pregnancy
• Injuries in the upper limbs
• Other neurological diseases or cancer
• Osteosynthesis material or pacemaker
• Botulinum toxin or antispastic treatment 3 months prior to studying.
• Any contraindication to massage and Tecar as skin infections, inflammatory vascular diseases, or acute inflammation.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delta University for Science and Technology

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rewan Magdy Aloush

Demonestrator for Physical Therapy for Neurology and Its Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy Delta University

Gamasa, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rewan M Aloush

Role: CONTACT

rewan.aloush@gmail.com

+201024232512

Muhammed E Abulftouh

Role: CONTACT

ftoh1996@gmail.com

+201023292028

Facility Contacts

Ibrahim A Abu Ella, PHD

Role: primary

ibrahimneuron@gmail.com

+201008442281

Other Identifiers

RADIOFREQUENCY AND ULTRASOUND

Identifier Type: -

Identifier Source: org_study_id