Stroke ( 3 Months After Onset)TECARNCT07131943
Radiofrequency vs. Ultrasound Therapy for Shoulder Joint in Stroke Patients: A Comparative Clinical Trial
A study testing Radiofrequency, Ultrasound and The designed physical therapy program in people with Stroke ( 3 Months After Onset) and Stroke in Patients: New Tool to Evaluate the Impact in Their Life, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Stroke ( 3 Months After Onset), Stroke in Patients: New Tool to Evaluate the Impact in Their Life
- What is being tested?
- Radiofrequency, Ultrasound and The designed physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Sep 2025to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Radiofrequency, Ultrasound, The designed physical therapy program
- Keywords
- Stroke, Hemiplegia, TECAR, Radiofrequency, Shoulder Pain
- Medical subject headings
- Stroke, Hemiplegia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
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.
UltrasoundDevice
Also called US
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.
The designed physical therapy programOther
Also called Treatment Exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: The designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start28 Sep 2025
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke ( 3 Months After Onset)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Delta University for Science and Technology
- Responsible party
- Principal investigator, Rewan Magdy Aloush, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131943
- Sponsor's protocol ID
- RADIOFREQUENCY AND ULTRASOUND
- Acronym
- TECAR
- Status last verified
- Jun 2026
- First submitted
- 13 Aug 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Radiofrequency and Ultrasound on Shoulder Pain, Range of Motion, and Functional Outcomes in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07131943
- Acronym / sponsor ID
- TECAR / RADIOFREQUENCY AND ULTRASOUND
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Delta University for Science and Technology
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group (GI)= 15 will be treated by Radiofrequency TECAR Therapy | Experimental | Device: RadiofrequencyGroup (GI) will be treated by Radiofrequency TECAR Therapy on shoulder joint as well as Designed Physical Therapy Program |
| Group (GII)= 15 will be treated by Ultrasound Therapy | Experimental | Device: UltrasoundGroup (GII) will be treated by Ultrasound Therapy on shoulder joint as well as Designed Physical Therapy Program |
| Group (GIII)= 15 will be treated by Designed Physical Therapy Program, | Experimental | Other: The designed physical therapy programGroup (GIII) will be treated by Designed Physical Therapy Program, all outcomes' measures will be assessed pre and post treatment. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- The following patients will be excluded from the study patients with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyRadiofrequency (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. | Device | Group (GI)= 15 will be treated by Radiofrequency TECAR Therapy |
| UltrasoundAlso: USThe 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. | Device | Group (GII)= 15 will be treated by Ultrasound Therapy |
| The designed physical therapy programAlso: Treatment ExercisesThe 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 | Group (GIII)= 15 will be treated by Designed Physical Therapy Program, |
Primary outcome
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
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Recruiting
The Effects of Virtual Reality-based Training for the Treatment of Neglect Syndrome in Stroke: a Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency, Ultrasound and The designed physical therapy program in people with Stroke ( 3 Months After Onset) and Stroke in Patients: New Tool to Evaluate the Impact in Their Life, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Goniometer for shoulder range of motion (time frame: 4 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.