Trial Outcomes & Findings for Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome (NCT NCT04420572)

NCT ID: NCT04420572

Last Updated: 2021-10-21

Results Overview

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: day 0 (before intervention)
• Results posted on: 2021-10-21

Participant Flow

Participant milestones

Measure	Ozone Injection Group The patients in the OI group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study	Steroid Injection Group A single dose injection was given to the patients in the CSI group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Overall Study STARTED	33	30
Overall Study COMPLETED	33	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome

Baseline characteristics by cohort

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	53.85 years STANDARD_DEVIATION 11.82 • n=5 Participants	54.87 years STANDARD_DEVIATION 12.95 • n=7 Participants	54.33 years STANDARD_DEVIATION 12.28 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Turkey	33 participants n=5 Participants	30 participants n=7 Participants	63 participants n=5 Participants
Body Mass Index	26.68 kg/m^2 STANDARD_DEVIATION 4.41 • n=5 Participants	29.64 kg/m^2 STANDARD_DEVIATION 4.37 • n=7 Participants	29.14 kg/m^2 STANDARD_DEVIATION 4.38 • n=5 Participants

PRIMARY outcome

Timeframe: day 0 (before intervention)

Population: intent to treat population(all participants)

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Pain Severity	8.36 score on a scale Standard Deviation 1.06	8.17 score on a scale Standard Deviation 0.95

PRIMARY outcome

Timeframe: 1 week after intervention

Population: intent to treat population(all participants)

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Pain Severity	3.64 score on a scale Standard Deviation 2.28	2.93 score on a scale Standard Deviation 2.27

PRIMARY outcome

Timeframe: 1 month after intervention

Population: intent to treat population(all participants)

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Pain Severity	3.30 score on a scale Standard Deviation 3.15	3.00 score on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: day 0 (before intervention)

Population: intent to treat population(all participants)

harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Functionality	53.03 score on a scale Standard Deviation 5.87	53.03 score on a scale Standard Deviation 5.97

SECONDARY outcome

Timeframe: 1 week after intervention

Population: intent to treat population(all participants)

harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Functionality	72.85 score on a scale Standard Deviation 12.02	75.00 score on a scale Standard Deviation 7.56

SECONDARY outcome

Timeframe: 1 month after intervention

Population: intent to treat population(all participants)

harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Functionality	72.79 score on a scale Standard Deviation 12.58	74.97 score on a scale Standard Deviation 6.89

SECONDARY outcome

Timeframe: day 0 (before intervention)

Population: intent to treat population(all participants)

Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.

38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.

Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Patient Reported Quality of Life - Notthingham Health Profile	261.72 score on a scale Standard Deviation 109.77	255.51 score on a scale Standard Deviation 127.22

SECONDARY outcome

Timeframe: 1 week after intervention

Population: intent to treat population(all participants)

Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.

38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.

Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Patient Reported Quality of Life - Notthingham Health Profile	215.40 score on a scale Standard Deviation 106.58	193.04 score on a scale Standard Deviation 103.10

SECONDARY outcome

Timeframe: 1 month after intervention

Population: intent to treat population(all participants)

Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.

38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.

Overall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status

Outcome measures

Measure	Ozone Injection Group n=33 Participants The patients in the ozone injection (OI) group received injections on the 1st, 4th, 7th and 10th days. A gas mixture containing 10 cc of 5% O3 and 95% medical O2 at a concentration of 25 μg/ml in the first application, 20 μg/ml in the second application, and 15 μg/ml in the third and fourth applications was used. It was the same physician who prepared and administered ozone. Experience has shown that a single dose of ozone application is not sufficient, it must be applied in sessions for a strong effect. Therefore, we used 4 doses of OI instead of a single dose in our study.	Steroid Injection Group n=30 Participants A single dose injection was given to the patients in the corticosteroids (CSI) group. The solution to be administered to the CSI group was obtained by mixing 1 ml of 2% lidocaine and 1 ml of betamethasone (Diprospan 2 mg/1ml+5 mg/1ml). It was the same physician who prepared and administered the solutions. In the studies, it was generally applied as a single dose and mixed with local anesthetic (LA). Therefore, in our study, we also applied it as a single dose by mixing it with LA.
Patient Reported Quality of Life - Notthingham Health Profile	210.28 score on a scale Standard Deviation 108.58	188.62 score on a scale Standard Deviation 109.10

Adverse Events

Ozone Injection Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Steroid Injection Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adem Erbirol

SultanAbdulhamid

Phone: +905426608788

Email: aerbirol@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place