Back to resultsComparison of Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Rotator Cuff Tendinopathy
Primary Purpose
Rotator Cuff Tendinopathy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ozone (O2-O3) injection
Corticosteroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tendinopathy focused on measuring rotator cuff tendinopathy, ozone, steroid, ultrasonography
Eligibility Criteria
Inclusion Criteria:
- aged between 18 and 70 years
- pain in the shoulder region and increase in pain with overhead-throwing activity
- chronic shoulder pain for more than 3 months
- partial rotator cuff tear or rotator cuff tendinosis diagnosed by US or magnetic resonance imaging (MRI).
Exclusion Criteria:
- a full-thickness rotator cuff tear diagnosed by US or MRI
- allergic reaction betamethasone or lidocaine
- contraindications for ozone (O2-O3) injection, such as uncontrolled hyperthyroidism, glucose-6 phosphate dehydrogenase deficiency (G6PDD), pregnancy and platelet level <50 103/µL
- history of coagulopathy, diabetes, or hepatitis
- intra-articular/subacromial injections in the last 3 months
- history of shoulder infection, fracture, trauma, bony lesion, tumor or inflammatory rheumatic diseases
- history of brachial plexus lesion/cervical radiculopathy.
Sites / Locations
- Merve Örücü Atar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Ozone (O2-O3) group
Corticosteroid group
Arm Description
Ultrasound (US)-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. 3 sessions (1 session/week) of 5 mL of ozone (O2-O3) will be injected (with a concentration of 10 μg/mL in the first session, 15 μg/mL in the second session, and 20 μg/mL in the third session).
US-guided injection will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. A mixture of 1 mL corticosteroid (betamethasone 3 mg/mL) and 1 mL lidocaine (20 mg) will be injected (1 session).
Outcomes
Primary Outcome Measures
The Western Ontario Rotator Cuff Index (WORC)
The Western Ontario Rotator Cuff Index (WORC) is a self-administered assessment tool for rotator cuff disease. WORC has 21 questions in 5 domains consisting of work, physical symptoms, social well-being, emotional well-being, and sports and recreation. Each question is scored on a 100-mm, with higher scores demonstrating larger problems. Turkish validity of the WORC has been illustrated.
Secondary Outcome Measures
The Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a 13 item self-assessment measurement tool to evaluate disability (8 items) and pain (5 items). The subscales of disability and pain are measured as the average of the corresponding items between 0-100, with higher scores indicating greater disability and pain.
Visual Analogue Scale (VAS)
The severity of the patients' shoulder pain in the last week will be evaluated using the 10-point VAS (from 0 (no pain) to 10 (worst imaginable pain))
Full Information
NCT ID
NCT05207384
First Posted
December 25, 2021
Last Updated
June 13, 2022
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05207384
Brief Title
Comparison of Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Rotator Cuff Tendinopathy
Official Title
Comparison of Ultrasound-Guided Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Chronic Rotator Cuff Tendinopathy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain.
The aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.
Detailed Description
Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain.
There are limited studies comparing the efficacy of ozone and corticosteroid injections in rotator cuff tendinopathy. In this context, the aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinopathy
Keywords
rotator cuff tendinopathy, ozone, steroid, ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome measures will be evaluated by an independent physiatrist, blinded for the assigned treatment.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ozone (O2-O3) group
Arm Type
Active Comparator
Arm Description
Ultrasound (US)-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. 3 sessions (1 session/week) of 5 mL of ozone (O2-O3) will be injected (with a concentration of 10 μg/mL in the first session, 15 μg/mL in the second session, and 20 μg/mL in the third session).
Arm Title
Corticosteroid group
Arm Type
Other
Arm Description
US-guided injection will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. A mixture of 1 mL corticosteroid (betamethasone 3 mg/mL) and 1 mL lidocaine (20 mg) will be injected (1 session).
Intervention Type
Procedure
Intervention Name(s)
Ozone (O2-O3) injection
Intervention Description
US-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. 3 sessions (1 session/week) of 5 mL of ozone (O2-O3) will be injected (with a concentration of 10 μg/mL in the first session, 15 μg/mL in the second session, and 20 μg/mL in the third session).
Intervention Type
Procedure
Intervention Name(s)
Corticosteroid injection
Intervention Description
US-guided injections will be performed with a 5-12 MHz linear transducer (Logic e portable; GE Healthcare, China) by the same physiatrist and injections will be administered into the subacromial bursa with a posterolateral approach. A mixture of 1 mL corticosteroid (betamethasone 3 mg/mL) and 1 mL lidocaine (20 mg) will be injected (1 session).
Primary Outcome Measure Information:
Title
The Western Ontario Rotator Cuff Index (WORC)
Description
The Western Ontario Rotator Cuff Index (WORC) is a self-administered assessment tool for rotator cuff disease. WORC has 21 questions in 5 domains consisting of work, physical symptoms, social well-being, emotional well-being, and sports and recreation. Each question is scored on a 100-mm, with higher scores demonstrating larger problems. Turkish validity of the WORC has been illustrated.
Time Frame
at baseline and change from baseline WORC at 4 weeks and 12 weeks after injections
Secondary Outcome Measure Information:
Title
The Shoulder Pain and Disability Index (SPADI)
Description
The Shoulder Pain and Disability Index (SPADI) is a 13 item self-assessment measurement tool to evaluate disability (8 items) and pain (5 items). The subscales of disability and pain are measured as the average of the corresponding items between 0-100, with higher scores indicating greater disability and pain.
Time Frame
at baseline and change from baseline SPADI at 4 weeks and 12 weeks after injections
Title
Visual Analogue Scale (VAS)
Description
The severity of the patients' shoulder pain in the last week will be evaluated using the 10-point VAS (from 0 (no pain) to 10 (worst imaginable pain))
Time Frame
at baseline and change from baseline VAS at 4 weeks and 12 weeks after injections
Other Pre-specified Outcome Measures:
Title
Ultrasonographic measurements
Description
supraspinatus tendon thickness, subacromial bursa thickness and acromiohumeral distance will be measured by US in both groups
Time Frame
at baseline and change from baseline ultrasonographic measurements at 4 weeks and 12 weeks after injections
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged between 18 and 70 years
pain in the shoulder region and increase in pain with overhead-throwing activity
chronic shoulder pain for more than 3 months
partial rotator cuff tear or rotator cuff tendinosis diagnosed by US or magnetic resonance imaging (MRI).
Exclusion Criteria:
a full-thickness rotator cuff tear diagnosed by US or MRI
allergic reaction betamethasone or lidocaine
contraindications for ozone (O2-O3) injection, such as uncontrolled hyperthyroidism, glucose-6 phosphate dehydrogenase deficiency (G6PDD), pregnancy and platelet level <50 103/µL
history of coagulopathy, diabetes, or hepatitis
intra-articular/subacromial injections in the last 3 months
history of shoulder infection, fracture, trauma, bony lesion, tumor or inflammatory rheumatic diseases
history of brachial plexus lesion/cervical radiculopathy.
Facility Information:
Facility Name
Merve Örücü Atar
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Rotator Cuff Tendinopathy
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