Supraspinatus TendinitisNCT07316738
Effect of Ozonated Gel Phonophoresis on Pain and Functional Disability in Patients With Chronic Supraspinatus Tendinitis
A study testing ozonated gel phonophoresis and conventional treatment in people with Supraspinatus Tendinitis, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of ozonated gel phonophoresis on pain intensity, shoulder joint range of motion, and functional disability in patients with chronic supraspinatus tendinitis grades I and II. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Supraspinatus Tendinitis
- What is being tested?
- ozonated gel phonophoresis and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients from 30-60 years old from both genders.
- The patients will be assigned to the study will be diagnosed with grade I or II supraspinatus tendinitis based on Neer's classification.
- The patients suffered from supraspinatus tendinitis for more than 3 months and taking non-steroidal anti-inflammatory drugs suggested by orthopedist.
- All patients have body mass index between 18.5 and 29.9 kg/m2.
Who cannot join
- Grades III of supraspinatus tendinitis. (Bone spurs and tendon rapture)
- Any past shoulder surgical interventions. (Rotator cuff repair, labrum tear and open reduction internal fixation)
- Shoulder joint instability
- Shoulder fracture.
- Non-cooperative subjects.
- Neuromuscular diseases (spinal muscular atrophy, whiplash injury)
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- Cardiovascular disease.
- History of cancer.
- Systemic diseases such as rheumatoid arthritis, Reiter's syndrome, or diabetes.
- Severe medical and neurological or psychiatric disorders.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nouran Ahmed Ibrahim, PhD contact
Egypt1 site
AL-Nasaem outpatient clinic
Cairo
Ahmed Mohsen Ali Abdullah, B.Sc, +20 101 033 2374, ahmedmohsen1902@gmail.com
About this study
This study will be conducted to investigate the effect of ozonated gel phonophoresis on pain intensity, shoulder joint range of motion, and functional disability in patients with chronic supraspinatus tendinitis grades I and II.
Read the detailed description
Tendinopathy is a condition in which pain arises on tendon near origin or insertion due to repetitive activities and reduced functional level, it occurs when the tendon does not properly heal.
Thirty percentages of tendinopathies in musculoskeletal conditions are shoulder pain related where supraspinatus tendinitis is the third most prevalent problem.
The primary function of the supraspinatus muscle is shoulder abduction, particularly movements that elevate the arm overhead. During these motions, the supraspinatus tendon repeatedly passes beneath the acromion process of the scapula, which can result in impingement and subsequent inflammation. If this condition progresses, an unexpected force or trauma may cause partial or complete rupture of the tendon.
Phonophoresis was first used to treat polyarthritis of hand by driving hydrocortisone ointment into inflamed areas in 1994. Since then it has been used in the treatment of various dermatological and musculoskeletal disorders.
The major medications used today with phonophoresis include the anti-inflammatories (cortisol, dexamethasone, salicylates) and local anaesthetics (lidocaine). Cameroy reports success using Carbocaine phonophoresis before closed reduction of Colles fractures.
The main purpose of phonophoresis is to achieve a suitable and fast concentration of drug in the tissue without inactivating the drug molecules with no side effects. In this efficient method, this has had wide utility in physical therapy and sports medicine. The drug is applied locally at the target site and messaged with a therapeutic ultrasound applicator.
Ozone therapy is a potential minimally invasive, conservative treatment that can be used alone or in conjunction with other therapies to help people with musculoskeletal diseases perform better and experience less pain. According to various studies, the effectiveness and safety of ozone therapy have primarily been researched in cases of knee osteoarthritis and on back pain.
Several papers suggested relevant medical features of O3, including inflammatory modulation and circulatory stimulation, with multiple applications in several medical fields including wound healing, ischemic disorders, infections and chronic inflammatory conditions like musculoskeletal disorders.
In the available literature there is no studies were done to identify the effect of ozonated gel phonophoresis in management of patients with chronic supraspinatus tendinitis grade I \& II.
So this study may add a piece of information to the therapists in the governmental hospitals and private clinics to be aware about the efficacy of this approach during dealing with patients of chronic supraspinatus tendinitis grade I \& II.
- Conditions
- Supraspinatus Tendinitis
- Being tested
- ozonated gel phonophoresis, conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozonated gel phonophoresisOther
Patients will receive ultrasonic with ozonated gel as a coupling medium (phonophoresis) (1 MHz, 1 W/cm2 continuous mode) for 5 min, three times per week for four weeks.
conventional treatmentOther
Patients will receive conventional treatment consisting of hot pack application and stretching exercises targeting the upper trapezius and pectoralis minor muscles. Stretching will be performed for three repetitions, each held for 30 seconds with 30 seconds of rest between repetitions. This will be followed by strengthening exercises for the external shoulder rotators, lower trapezius, and serratus anterior muscles using color-coded elastic resistance bands, performed as three sets of ten repetitions for each muscle group.Treatment sessions will be conducted three times per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| ozonated gel phonophoresis + conventional treatment | Experimental | Twenty patients will receive ozonated gel phonophoresis in addition to conventional treatment, three times per week for four weeks. Receives: Other: ozonated gel phonophoresis; Other: conventional treatment |
| conventional treatment | Active comparator | Twenty patients will receive conventional treatment consisting of hot pack application and stretching exercises targeting the upper trapezius and pectoralis minor muscles. Stretching will be performed for three repetitions, each held for 30 seconds with 30 seconds of rest between repetitions. This will be followed by strengthening exercises for the external shoulder rotators, lower trapezius, and serratus anterior muscles using color-coded elastic resistance bands, performed as three sets of ten repetitions for each muscle group. In addition, ultrasound therapy will be applied at a frequency of 1 MHz and an intensity of 0.8 W/cm² for 7 minutes. Treatment sessions will be conducted three times per week for four weeks. Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain intensity of shoulder joint
Pain intensity of the shoulder joint will be assessed using the Visual Analog Scale (VAS) in patients with chronic supraspinatus tendinitis. Patients will be asked to place a mark on a horizontal line to indicate the intensity of their pain, where the left end represents no pain and the right end represents the worst pain imaginable. VAS scores will be interpreted as follows: 0-30 indicates mild symptoms, 31-60 indicates moderate symptoms, and 61-100 indicates severe symptoms.
Measured: 4 weeks
Assessment of Functional disability
The Quick Disabilities of the Arm, Shoulder, and Hand Scale (Quick DASH; Q-DASH) will be used to evaluate shoulder dysfunction. The QuickDASH consists of 11 items extracted from the original 30-item DASH questionnaire, including 8 function/disability items and 3 symptom items. Each item is scored on a 5-point scale ranging from 1 (no difficulty) to 5 (unable to do), with total scores ranging from 0 to 100, where higher scores indicate greater disability.
Measured: 4 weeks
Secondary outcomes (2)
Assessment of Shoulder abduction range of motion
A digital goniometer will be used to assess shoulder joint abduction range of motion in patients with chronic supraspinatus tendinitis before and after the treatment sessions. Measurements will be taken with the patient in the supine position. The fulcrum of the goniometer will be centered at the anterior aspect of the acromion process, the stationary arm will be aligned parallel to the midline of the torso, and the moving arm will be aligned with the midline of the humerus, pointing toward the medial epicondyle of the elbow.
Measured: 4 weeks
Assessment of Shoulder External Rotation range of motion
Shoulder joint external rotation range of motion will also be assessed using a digital goniometer before and after the treatment sessions in patients with chronic supraspinatus tendinitis. The patient will be positioned supine during measurement. The fulcrum of the goniometer will be centered over the olecranon process of the elbow, the stationary arm will be aligned perpendicular to the floor, and the moving arm will be aligned with the ulna, pointing toward the ulnar styloid process.
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 posted5 Jan 2026
- Study start25 Dec 2025 (estimated)
- Primary completion25 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TendinitisStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohsen Ali Abdallah, Cairo University
- Investigators
- Yasser Ramzy Lasheen, PhD, Study chair, Assistant Professor, Cairo UniversityNouran Ahmed Ibrahim, PhD, Study director, Lecturer, Cairo universityMohamed Osama Hegazy, PhD, Study director, Professor, Banha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316738
- Sponsor's protocol ID
- P.T.REC/012/006041
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ozonated Gel Phonophoresis on Pain and Functional Disability in Patients With Chronic Supraspinatus Tendinitis
- ClinicalTrials.gov ID
- NCT07316738
- Acronym / sponsor ID
- P.T.REC/012/006041
- Conditions
- Supraspinatus Tendinitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
This study will be conducted to investigate the effect of ozonated gel phonophoresis on pain intensity, shoulder joint range of motion, and functional disability in patients with chronic supraspinatus tendinitis grades I and II.
Detailed description
Tendinopathy is a condition in which pain arises on tendon near origin or insertion due to repetitive activities and reduced functional level, it occurs when the tendon does not properly heal.
Thirty percentages of tendinopathies in musculoskeletal conditions are shoulder pain related where supraspinatus tendinitis is the third most prevalent problem.
The primary function of the supraspinatus muscle is shoulder abduction, particularly movements that elevate the arm overhead. During these motions, the supraspinatus tendon repeatedly passes beneath the acromion process of the scapula, which can result in impingement and subsequent inflammation. If this condition progresses, an unexpected force or trauma may cause partial or complete rupture of the tendon.
Phonophoresis was first used to treat polyarthritis of hand by driving hydrocortisone ointment into inflamed areas in 1994. Since then it has been used in the treatment of various dermatological and musculoskeletal disorders.
The major medications used today with phonophoresis include the anti-inflammatories (cortisol, dexamethasone, salicylates) and local anaesthetics (lidocaine). Cameroy reports success using Carbocaine phonophoresis before closed reduction of Colles fractures.
The main purpose of phonophoresis is to achieve a suitable and fast concentration of drug in the tissue without inactivating the drug molecules with no side effects. In this efficient method, this has had wide utility in physical therapy and sports medicine. The drug is applied locally at the target site and messaged with a therapeutic ultrasound applicator.
Ozone therapy is a potential minimally invasive, conservative treatment that can be used alone or in conjunction with other therapies to help people with musculoskeletal diseases perform better and experience less pain. According to various studies, the effectiveness and safety of ozone therapy have primarily been researched in cases of knee osteoarthritis and on back pain.
Several papers suggested relevant medical features of O3, including inflammatory modulation and circulatory stimulation, with multiple applications in several medical fields including wound healing, ischemic disorders, infections and chronic inflammatory conditions like musculoskeletal disorders.
In the available literature there is no studies were done to identify the effect of ozonated gel phonophoresis in management of patients with chronic supraspinatus tendinitis grade I \& II.
So this study may add a piece of information to the therapists in the governmental hospitals and private clinics to be aware about the efficacy of this approach during dealing with patients of chronic supraspinatus tendinitis grade I \& II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozonated gel phonophoresis + conventional treatment | Experimental | Other: ozonated gel phonophoresis, Other: conventional treatmentTwenty patients will receive ozonated gel phonophoresis in addition to conventional treatment, three times per week for four weeks. |
| conventional treatment | Active comparator | Other: conventional treatmentTwenty patients will receive conventional treatment consisting of hot pack application and stretching exercises targeting the upper trapezius and pectoralis minor muscles. Stretching will be performed for three repetitions, each held for 30 seconds with 30 seconds of rest between repetitions. This will be followed by strengthening exercises for the external shoulder rotators, lower trapezius, and serratus anterior muscles using color-coded elastic resistance bands, performed as three sets of ten repetitions for each muscle group. In addition, ultrasound therapy will be applied at a frequency of 1 MHz and an intensity of 0.8 W/cm² for 7 minutes. Treatment sessions will be conducted three times per week for four weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients from 30-60 years old from both genders.
- The patients will be assigned to the study will be diagnosed with grade I or II supraspinatus tendinitis based on Neer's classification.
- The patients suffered from supraspinatus tendinitis for more than 3 months and taking non-steroidal anti-inflammatory drugs suggested by orthopedist.
- All patients have body mass index between 18.5 and 29.9 kg/m2.
Key exclusion criteria (11 listed)
- Grades III of supraspinatus tendinitis. (Bone spurs and tendon rapture)
- Any past shoulder surgical interventions. (Rotator cuff repair, labrum tear and open reduction internal fixation)
- Shoulder joint instability
- Shoulder fracture.
- Non-cooperative subjects.
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 |
|---|---|---|
| ozonated gel phonophoresisPatients will receive ultrasonic with ozonated gel as a coupling medium (phonophoresis) (1 MHz, 1 W/cm2 continuous mode) for 5 min, three times per week for four weeks. | Other | ozonated gel phonophoresis + conventional treatment |
| conventional treatmentPatients will receive conventional treatment consisting of hot pack application and stretching exercises targeting the upper trapezius and pectoralis minor muscles. Stretching will be performed for three repetitions, each held for 30 seconds with 30 seconds of rest between repetitions. This will be followed by strengthening exercises for the external shoulder rotators, lower trapezius, and serratus anterior muscles using color-coded elastic resistance bands, performed as three sets of ten repetitions for each muscle group.Treatment sessions will be conducted three times per week for four weeks. | Other | conventional treatment, ozonated gel phonophoresis + conventional treatment |
Primary outcome
Assessment of Pain intensity of shoulder joint
Time frame: 4 weeks
Pain intensity of the shoulder joint will be assessed using the Visual Analog Scale (VAS) in patients with chronic supraspinatus tendinitis. Patients will be asked to place a mark on a horizontal line to indicate the intensity of their pain, where the left end represents no pain and the right end represents the worst pain imaginable. VAS scores will be interpreted as follows: 0-30 indicates mild symptoms, 31-60 indicates moderate symptoms, and 61-100 indicates severe symptoms.
Assessment of Functional disability
Time frame: 4 weeks
The Quick Disabilities of the Arm, Shoulder, and Hand Scale (Quick DASH; Q-DASH) will be used to evaluate shoulder dysfunction. The QuickDASH consists of 11 items extracted from the original 30-item DASH questionnaire, including 8 function/disability items and 3 symptom items. Each item is scored on a 5-point scale ranging from 1 (no difficulty) to 5 (unable to do), with total scores ranging from 0 to 100, where higher scores indicate greater disability.
2 secondary outcomes
Assessment of Shoulder abduction range of motion
Time frame: 4 weeks
Assessment of Shoulder External Rotation range of motion
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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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.
Nouran Ahmed Ibrahim, PhD contact
Yasser Ramzy Lasheen, PhD study chair
Assistant Professor, Cairo University
Nouran Ahmed Ibrahim, PhD study director
Lecturer, Cairo university
Mohamed Osama Hegazy, PhD study director
Professor, Banha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozonated gel phonophoresis and conventional treatment in people with Supraspinatus Tendinitis, 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 4 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: opening soon, as of the sponsor's last update on 5 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohsen Ali Abdullah, B.Sc (+20 101 033 2374, ahmedmohsen1902@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain intensity of shoulder joint (time frame: 4 weeks). The study lists 2 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 5 Jan 2026.