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

NCT07316738 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006041
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraspinatus Tendinitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 weeks

Secondary Outcomes (2)

• Assessment of Shoulder abduction range of motion

  4 weeks

• Assessment of Shoulder External Rotation range of motion

  4 weeks

Study Arms (2)

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.

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.

Other: conventional treatment

Interventions

ozonated gel phonophoresis 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.

ozonated gel phonophoresis + conventional treatment

conventional treatment 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; ozonated gel phonophoresis + conventional treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

AL-Nasaem outpatient clinic

Cairo, Egypt

Location

Study Officials

• Yasser Ramzy Lasheen, PhD

  Assistant Professor, Cairo University

  STUDY CHAIR

• Nouran Ahmed Ibrahim, PhD

  Lecturer, Cairo university

  STUDY DIRECTOR

• Mohamed Osama Hegazy, PhD

  Professor, Banha University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Mohsen Ali Abdullah, B.Sc

CONTACT

+20 101 033 2374; ahmedmohsen1902@gmail.com

Nouran Ahmed Ibrahim, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: December 25, 2025
• Primary Completion: February 25, 2026
• Study Completion: March 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

EG (1)