Comparing the effects of corticosteroid and ozone injections on rotator cuff tendinopathy

Comparing the effects of corticosteroid and ozone injections alone and in combination on rotator cuff tendinopathy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241211064021N5

Enrollment

Registered

2025-04-08

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of corticosteroid and ozone injections alone and in combination on rotator cuff tendinopathy. Rotator cuff tear or rupture, not specified as traumatic

Interventions

Intervention 1: Intervention Group 1: Ozone injection will be performed for patients in Group B. First, a shoulder ultrasound is performed, then, under ultrasound guidance, three sessions of ozone are

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Duration of diagnosis at least 3 months Rotator cuff tendinosis or incomplete supraspinatus tear

Exclusion criteria

Exclusion criteria: Intra-articular/subacromial injection within the last 3 months Patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs)

Design outcomes

Primary

Measure	Time frame
Comparing the effectiveness of local corticosteroid injection (LCI) and ozone on improving the condition and pain of patients with rotator cuff tendinopathy. Timepoint: Determination and comparison of the average pain and disability (DASH) score before, one month after, and three months after treatment in patients with rotator cuff tendinopathy in three groups of local corticosteroid and ozone injection alone and in combination. Method of measurement: The visual analog scale (VAS) will be used to assess pain intensity. In the VAS scale, the patient expresses their pain level using a ruler and their tongue, with 0 being the most severe pain the patient can describe and 10 being the most severe pain they can describe. The scoring is as follows:Vas 0 = no painVas 1-3 = mild painVas 4-6 = moderate painVas 7-10 = severe pain.	—

Measure

Time frame

Comparing the effectiveness of local corticosteroid injection (LCI) and ozone on improving the condition and pain of patients with rotator cuff tendinopathy. Timepoint: Determination and comparison of the average pain and disability (DASH) score before, one month after, and three months after treatment in patients with rotator cuff tendinopathy in three groups of local corticosteroid and ozone injection alone and in combination. Method of measurement: The visual analog scale (VAS) will be used to assess pain intensity. In the VAS scale, the patient expresses their pain level using a ruler and their tongue, with 0 being the most severe pain the patient can describe and 10 being the most severe pain they can describe. The scoring is as follows:Vas 0 = no painVas 1-3 = mild painVas 4-6 = moderate painVas 7-10 = severe pain.

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Secondary

Measure	Time frame
Changes in the thickness of the rotator cuff muscle tendon (on ultrasound) before and three months after treatment in patients with rotator cuff tendinopathy in three groups of local corticosteroid and ozone injection alone and together, by age, gender, and dominant hand. Timepoint: Changes in the thickness of the rotator cuff muscle tendon (on ultrasound) before and three months after treatment in patients with rotator cuff tendinopathy in three groups of local corticosteroid and ozone injection alone and together, by age, gender, and dominant hand. Method of measurement: Ultrasound is used to assess tendon thickness. The thickness of the supraspinatus tendon and the thickness of the subacromial bursa at the thickest part in the short-axis position and with the hand in internal rotation are measured in all three groups by ultrasound at the beginning of the study (before treatment) and three months after injection.	—

Measure

Time frame

Changes in the thickness of the rotator cuff muscle tendon (on ultrasound) before and three months after treatment in patients with rotator cuff tendinopathy in three groups of local corticosteroid and ozone injection alone and together, by age, gender, and dominant hand. Timepoint: Changes in the thickness of the rotator cuff muscle tendon (on ultrasound) before and three months after treatment in patients with rotator cuff tendinopathy in three groups of local corticosteroid and ozone injection alone and together, by age, gender, and dominant hand. Method of measurement: Ultrasound is used to assess tendon thickness. The thickness of the supraspinatus tendon and the thickness of the subacromial bursa at the thickest part in the short-axis position and with the hand in internal rotation are measured in all three groups by ultrasound at the beginning of the study (before treatment) and three months after injection.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh Esmaili

Hamedan University of Medical Sciences

dr.taherehes@gmail.com+98 81 3131 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026