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

NCT07131943 | Recruiting

• 1 other identifier: RADIOFREQUENCY AND ULTRASOUND
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stroke; Hemiplegia; TECAR; Radiofrequency; Shoulder Pain

Outcome Measures

Primary Outcomes (4)

• Digital Goniometer for shoulder range of motion

  The digital goniometer (Baseline 12-1027 USA) will be used to assess range of motion (ROM) of the shoulder joint. The device consists of fixed arm, movable arm and screen. The device converts the angular displacement of the joint (represented in the degree of change of the angle between the two arms of the device) into an electric signal readout which is produced in a simple digital form. The device is the most accurate and objective method of ROM measurement with excellent inter-rater and intra-rater ranged from 0.89 to 0.98

  4 Weeks

• The pressure algometer

  The pressure algometer, specifically the hand-held Baseline® model, is a reliable and valid tool used to objectively measure pressure pain thresholds (PPT). It features a pistol-style grip and a pressure-sensitive gauge with a 0.785 cm² rubber tip. The device applies gradual, consistent manual force to determine the minimal pressure at which a sensation of pressure turns into pain. This method is widely used in clinical settings due to its strong correlation with pain intensity and excellent inter-rater reliability, making it a dependable tool for assessing pain sensitivity.

  4 weeks

• Numerical Rating Scale (NRS):

  Numerical Rating Scale (NRS): For pain Threshold will be assessed by Numeric pain rating scale (NPRS) is an 11-point (0-10) Scale will be used to measure pain. Patients verbally will select value between (0-10) based on intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline

  4 weeks

• Functional Outcome and disability / Shoulder pain and Disability Index (SPADI)

  The Shoulder Pain and Disability Index (SPADI) is a 13-item questionnaire used to assess the intensity of shoulder pain and the degree of functional disability. It includes two subscales: five questions evaluating pain severity and eight questions assessing difficulty with daily activities involving upper limb use. Patients mark their responses on a 10 cm visual analogue scale, with scores ranging up to 50 for pain, 80 for disability, and a total of 130, all expressed as percentages. SPADI has demonstrated strong validity and reliability, including in its Arabic version, with an intra-rater reliability coefficient of 0.89, making it a dependable tool for clinical and research use.

  4 weeks

Study Arms (3)

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

EXPERIMENTAL

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

Device: Radiofrequency

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

EXPERIMENTAL

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

Device: Ultrasound

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

EXPERIMENTAL

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

Other: The designed physical therapy program

Interventions

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

Ultrasound 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.

Also known as: US

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

The designed physical therapy program 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.

Also known as: Treatment Exercises

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

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Delta University for Science and Technology: collaborator

Study Sites (1)

Faculty of Physical Therapy Delta University

Gamasa, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia; Shoulder Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Rewan M Aloush

CONTACT

+201024232512; rewan.aloush@gmail.com

Muhammed E Abulftouh

CONTACT

+201023292028; ftoh1996@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonestrator for Physical Therapy for Neurology and Its Surgery

Model Details: 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). Therapeutic Equipment and tools TECAR (Transfer Electrical Capacitive and Resistive) therapy and ultrasound therapy are advanced non-invasive therapeutic modalities used in physiotherapy to accelerate tissue healing and pain relief. TECAR therapy utilizes radiofrequency energy to generate deep endogenous heat, enhancing blood flow.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: September 28, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)