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

• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
• Overall Status: Completed
• CT.gov ID: NCT04420572
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

Between the large trochanter and the muscles adhering to it, trochanteric bursa and several other bursa may be found. Trochanteric bursitis can be alone or together with tendinitis of other bursa and adhering muscles. The first is called trochanteric bursitis, the second is called hip periarthritis, which is difficult to distinguish clinically. It is more common in women of middle age. The main complaint is the large trochanter and pain on the side of the thigh. Pain is aggregated by walking abduction and external rotation by walking, lying down with hip movements. The palpation is sensitive to the top of the large trochanter. There may also be tenderness in the muscles in the lateral of the thigh. On plain radiographs, slight irregularities or peritrocanteric calcifications can be seen in the large trochanter. Bone scintigraphy shows local increased involvement. In differential diagnosis, stress fractures, local infection and bone and soft tissue tumors should be considered.

Rest is recommended in treatment. Activities such as running, standing for a long time are prohibited. Ice application can be given in the acute period. Non-steroidal anti-inflammatory (SOAI) drugs, analgesics, TENS can be used for pain relief. In cases where conventional treatments are insufficient, that is, the patient's pain is still continuing and functional recovery is inadequate, some alternative methods are also applied. These treatments include ozone, prolotherapy injection applications, dry needling, acupuncture, hirudotherapy, phytotherapy, mesotherapy, balneotherapy, kinesiobanding, etc. d. In our study, we aim to compare the effectiveness of ozone injection in patients diagnosed with trochanteric bursitis and to compare steroid injection with the application of ozone therapy.

Condition or Disease	Intervention/Treatment	Phase
Trochanteric Bursitis	Drug: ozone injection; Drug: betamethasone	N/A

Detailed Description

60 patients with trochanteric bursitis will be taken to the first and second groups by random number generator method. Ozone therapy is planned for 30 patients in the first group, and steroid injection is planned for the second group in 30 patients, and the study period is planned to be 4.5 months. Patients between the ages of 18-75 will be admitted and no difference will be made in terms of gender. The child will not be sick. Patients will be evaluated by the doctor who made the injection. All patients will also be evaluated before the first injection (T0), after treatment (T1) and after the first month (T2) after treatment. VAS (visual analog scale), Nottingham Health Profile and Harris Hip Evaluation Form will be used to evaluate patients. Our study is a randomized controlled prospective study.

Treatment to be applied to patients will be selected randomly. Steroid injections will be administered to patients in a single dose, while ozone injection will be applied in three doses (1, 4, 7, 10 days), with a total of 4 doses. In ozone injection applications, while 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected; 1ml betamethasone will be used for steroid injection. The evaluation of the patients will be done by a different physician than the physician who made the injections. The financial burden of the treatment applied will be borne by the researchers.

This study is a randomized controlled prospective clinical trial. The sample size is 60 patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: double
• Primary Purpose: Treatment
• Official Title: Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome
• Actual Study Start Date: Mar 11, 2021
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ozone injection group ozone injection will be applied in three doses (1st, 4th, 7th and 10th days) for a total of 4 doses. In ozone injection applications, 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected.	Drug: ozone injection; ozone injection will be applied in three doses (1st, 4th, 7th and 10th days) for a total of 4 doses. In ozone injection applications, 1st dose 25 gamma, 2nd dose 20 gamma, 3rd and 4th dose 15 gamma 10 cc ozone will be injected.; Other Names: no other names
Experimental: steroid injection group 1ml betamethasone will be used for steroid injection.	Drug: betamethasone; 1ml betamethasone will be used for steroid injection.; Other Names: no other names

Outcome Measures

Primary Outcome Measures

1. Pain Severity [day 0 (before intervention)]

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

2. Pain Severity [1 week after intervention]

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

3. Pain Severity [1 month after intervention]

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

Secondary Outcome Measures

1. Functionality [day 0 (before intervention)]

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

2. Functionality [1 week after intervention]

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

3. Functionality [1 month after intervention]

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

4. Patient Reported Quality of Life - Notthingham Health Profile [day 0 (before intervention)]

   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

5. Patient Reported Quality of Life - Notthingham Health Profile [1 week after intervention]

   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

6. Patient Reported Quality of Life - Notthingham Health Profile [1 month after intervention]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Over 18 years of age, under 75 years of age

2. Lateral hip pain

3. Having pain for at least 3 months

4. The VAS value should be minimum 4 and pain is increased by pressing on t.major.

5. Conservative treatment failure

Exclusion Criteria:

1. Motor and / or sensory impairment compatible with radiculopathy

2. Connective tissue disease

3. Pregnancy

4. Active infection, immune system disorders, unresolved fractures

5. Hip op history, bursectomy / ilio-tibial band elongation

6. Steroid injection history in the past 4 months

7. Physical therapy history for trochanteric bursitis in the last 4 months

8. Rheumatological patients, pregnancy, Patients with a history of cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sultan 2.Abdülhamid Han Training and Research Hospital	Istanbul	Eyalet/Yerleşke	Turkey	34000

Sponsors and Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

• Study Director: ADEM ERBİROL, sultan abdulhamid han

Study Documents (Full-Text)

• Study Protocol - Mar 1, 2021
• Statistical Analysis Plan - Aug 1, 2021

More Information

Publications

None provided.

• Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• ClinicalTrials.gov Identifier: NCT04420572
• Other Study ID Numbers: Adem Erbirol
• First Posted: Jun 9, 2020
• Last Update Posted: Oct 21, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: trochanteric bursitis; ozone; steroid; injection
• Additional relevant MeSH terms: Bursitis; Betamethasone

Study Results

Participant Flow

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	33	30
COMPLETED	33	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ozone Injection Group	Steroid Injection Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	33	30	63
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	26 78.8%	23 76.7%	49 77.8%
>=65 years	7 21.2%	7 23.3%	14 22.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.85 (11.82)	54.87 (12.95)	54.33 (12.28)
Sex: Female, Male (Count of Participants)
Female	28 84.8%	26 86.7%	54 85.7%
Male	5 15.2%	4 13.3%	9 14.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	33 100%	30 100%	63 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Turkey	33 100%	30 100%	63 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.68 (4.41)	29.64 (4.37)	29.14 (4.38)

Outcome Measures

1. Primary Outcome

Title	Pain Severity
Description	visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame	day 0 (before intervention)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	8.36 (1.06)	8.17 (0.95)

2. Primary Outcome

Title	Pain Severity
Description	visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame	1 week after intervention

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	3.64 (2.28)	2.93 (2.27)

3. Primary Outcome

Title	Pain Severity
Description	visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame	1 month after intervention

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	3.30 (3.15)	3.00 (2.41)

4. Secondary Outcome

Title	Functionality
Description	harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
Time Frame	day 0 (before intervention)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	53.03 (5.87)	53.03 (5.97)

5. Secondary Outcome

Title	Functionality
Description	harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
Time Frame	1 week after intervention

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	72.85 (12.02)	75.00 (7.56)

6. Secondary Outcome

Title	Functionality
Description	harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
Time Frame	1 month after intervention

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	72.79 (12.58)	74.97 (6.89)

7. Secondary Outcome

Title	Patient Reported Quality of Life - Notthingham Health Profile
Description	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
Time Frame	day 0 (before intervention)

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	261.72 (109.77)	255.51 (127.22)

8. Secondary Outcome

Title	Patient Reported Quality of Life - Notthingham Health Profile
Description	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
Time Frame	1 week after intervention

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	215.40 (106.58)	193.04 (103.10)

9. Secondary Outcome

Title	Patient Reported Quality of Life - Notthingham Health Profile
Description	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
Time Frame	1 month after intervention

Outcome Measure Data

Analysis Population Description

intent to treat population(all participants)

Arm/Group Title	Ozone Injection Group	Steroid Injection Group
Arm/Group Description	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.	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.
Measure Participants	33	30
Mean (Standard Deviation) [score on a scale]	210.28 (108.58)	188.62 (109.10)

Adverse Events

Time Frame	adverse events were not monitored/assessed
Adverse Event Reporting Description	adverse events were not monitored/assessed
Arm/Group Title	Ozone Injection Group		Steroid Injection Group
Arm/Group Description	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.		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.
All Cause Mortality
	Ozone Injection Group		Steroid Injection Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Ozone Injection Group		Steroid Injection Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Ozone Injection Group		Steroid Injection Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.