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

June 23, 2026 updated by: Rewan Magdy Aloush, Cairo University

Comparison Between Radiofrequency and Ultrasound on Shoulder Pain, Range of Motion, and Functional Outcomes in Patients With Stroke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Gamasa, Egypt
        • Faculty of Physical Therapy Delta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: 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.
Experimental: 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
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.
Other Names:
  • US
Experimental: 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.
Other: 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.
Other Names:
  • Treatment Exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Digital Goniometer for shoulder range of motion
Time Frame: 4 Weeks

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
Time Frame: 4 weeks
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):
Time Frame: 4 weeks

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)
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Delta University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RADIOFREQUENCY AND ULTRASOUND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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