Effect of Ozonated Gel Phonophoresis on Pain and Functional Disability in Patients With Chronic Supraspinatus Tendinitis

NCT ID: NCT07316738

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2026-03-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ozonated gel phonophoresis + conventional treatment

Twenty patients will receive ozonated gel phonophoresis in addition to conventional treatment, three times per week for four weeks.

Group Type: EXPERIMENTAL

ozonated gel phonophoresis

Intervention Type: OTHER

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 treatment

Intervention Type: OTHER

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.

conventional treatment

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.

Group Type: ACTIVE_COMPARATOR

conventional treatment

Intervention Type: OTHER

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.

Interventions

ozonated gel phonophoresis

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.

Intervention Type: OTHER

conventional treatment

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)
• 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.

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

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohsen Ali Abdallah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasser Ramzy Lasheen, PhD

Role: STUDY_CHAIR

Assistant Professor, Cairo University

Nouran Ahmed Ibrahim, PhD

Role: STUDY_DIRECTOR

Lecturer, Cairo university

Mohamed Osama Hegazy, PhD

Role: STUDY_DIRECTOR

Professor, Banha University

Locations

AL-Nasaem outpatient clinic

Cairo, , Egypt

Countries

Egypt

Central Contacts

Ahmed Mohsen Ali Abdullah, B.Sc

Role: CONTACT

ahmedmohsen1902@gmail.com

+20 101 033 2374

Nouran Ahmed Ibrahim, PhD

Role: CONTACT

Facility Contacts

Ahmed Mohsen Ali Abdullah, B.Sc

Role: primary

ahmedmohsen1902@gmail.com

+20 101 033 2374

Other Identifiers

P.T.REC/012/006041

Identifier Type: -

Identifier Source: org_study_id