Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04420572
Enrollment
63
Registered
2020-06-09
Start date
2021-03-11
Completion date
2021-08-01
Last updated
2021-10-21

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

Conditions

Trochanteric Bursitis

Keywords

trochanteric bursitis, ozone, steroid, injection

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.

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.

Interventions

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.

DRUGbetamethasone

1ml betamethasone will be used for steroid injection.

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pain Severityday 0 (before intervention)visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

Secondary

MeasureTime frameDescription
Functionalityday 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
Patient Reported Quality of Life - Notthingham Health Profileday 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

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Ozone Injection Group
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.
33
Steroid Injection Group
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.
30
Total63

Baseline characteristics

CharacteristicOzone Injection GroupSteroid Injection GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants7 Participants14 Participants
Age, Categorical
Between 18 and 65 years
26 Participants23 Participants49 Participants
Age, Continuous53.85 years
STANDARD_DEVIATION 11.82
54.87 years
STANDARD_DEVIATION 12.95
54.33 years
STANDARD_DEVIATION 12.28
Body Mass Index26.68 kg/m^2
STANDARD_DEVIATION 4.41
29.64 kg/m^2
STANDARD_DEVIATION 4.37
29.14 kg/m^2
STANDARD_DEVIATION 4.38
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
33 Participants30 Participants63 Participants
Region of Enrollment
Turkey
33 participants30 participants63 participants
Sex: Female, Male
Female
28 Participants26 Participants54 Participants
Sex: Female, Male
Male
5 Participants4 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Pain Severity

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

Time frame: day 0 (before intervention)

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupPain Severity8.36 score on a scaleStandard Deviation 1.06
Steroid Injection GroupPain Severity8.17 score on a scaleStandard Deviation 0.95
Primary

Pain Severity

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

Time frame: 1 week after intervention

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupPain Severity3.64 score on a scaleStandard Deviation 2.28
Steroid Injection GroupPain Severity2.93 score on a scaleStandard Deviation 2.27
Primary

Pain Severity

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

Time frame: 1 month after intervention

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupPain Severity3.30 score on a scaleStandard Deviation 3.15
Steroid Injection GroupPain Severity3.00 score on a scaleStandard Deviation 2.41
Secondary

Functionality

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)

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupFunctionality53.03 score on a scaleStandard Deviation 5.87
Steroid Injection GroupFunctionality53.03 score on a scaleStandard Deviation 5.97
Secondary

Functionality

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

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupFunctionality72.85 score on a scaleStandard Deviation 12.02
Steroid Injection GroupFunctionality75.00 score on a scaleStandard Deviation 7.56
Secondary

Functionality

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

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupFunctionality72.79 score on a scaleStandard Deviation 12.58
Steroid Injection GroupFunctionality74.97 score on a scaleStandard Deviation 6.89
Secondary

Patient Reported Quality of Life - Notthingham Health Profile

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)

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupPatient Reported Quality of Life - Notthingham Health Profile261.72 score on a scaleStandard Deviation 109.77
Steroid Injection GroupPatient Reported Quality of Life - Notthingham Health Profile255.51 score on a scaleStandard Deviation 127.22
Secondary

Patient Reported Quality of Life - Notthingham Health Profile

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

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupPatient Reported Quality of Life - Notthingham Health Profile215.40 score on a scaleStandard Deviation 106.58
Steroid Injection GroupPatient Reported Quality of Life - Notthingham Health Profile193.04 score on a scaleStandard Deviation 103.1
Secondary

Patient Reported Quality of Life - Notthingham Health Profile

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

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
Ozone Injection GroupPatient Reported Quality of Life - Notthingham Health Profile210.28 score on a scaleStandard Deviation 108.58
Steroid Injection GroupPatient Reported Quality of Life - Notthingham Health Profile188.62 score on a scaleStandard Deviation 109.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026