Clinical trial NCT04420572
Conditions: Trochanteric Bursitis
Keywords: trochanteric bursitis ozone steroid injection
Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Start date: 2021-03-11; Completion date: 2021-08-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 1ml betamethasone will be used for steroid injection.
Interventions: intervention 1: ozone injection intervention 2: betamethasone
Intervention descriptions: intervention 1: 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. intervention 2: 1ml betamethasone will be used for steroid injection.

Protocol documents:
Prot_000.pdf: 
Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain 
Syndrome 
NCT04420572 – 01.03.2021 
63 (sixty­three) patients were included in the study. Patients who were older than 18 years, 
had lateral hip pain for at least 3 months, had a VAS value of at least 4, had increased pain 
with pressing on the trochanter major, and failed conservative treatment were included in the 
study.  The  following  patients  were  excluded  from  the  study:  Motor  and/or  sensory 
impairment  compatible  with  radiculopathy,  connective  tissue  disease,  pregnancy,  active 
infection, immune system disorders, untreated fracture, hip operation, steroid injection in the 
last 4 months, and/or hip region physical therapy, rheumatologic disease, cancer. 
 
Evaluations were made before treatment (T0), 1 week after treatment (T1), and 1 month after 
treatment (T2). For the CSI group, T1 control was performed 1 week after CSI administration, 
and T2 control was performed 1 month after CSI administration. For the OI group, the T1 
control was performed 1 week after the 4th OI administration, and the T2 control 1 month 
after the 4th OI administration. Physicians performing the administration and evaluation were 
different, thus allowing the study to be blinded. In the study, patients' Visual Analogue Scale 
(VAS),  The  Harris  Hip  Score  (HHS)  and  The  Nottingham  Health  Profile  (NHP) 
questionnaires  were  filled.Patients  were  randomized  into  2  groups  according  to  Random 
Number Generation. The first group was determined as the ozone injection (OI) group and the 
second group as the corticosteroid injections (CSI) group. 
33 patients were included in the 1st group and 30 patients in the 2nd 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. 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. There will be pre­injection, postinjection 1st week and 1st month controls. 

SAP_001.pdf: 
Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain 
Syndrome 
NCT04420572 – 01.08.2021 
 
Statistical Analysis 
Statistical  analyses  were  done  using  SPSS  version  20  statistical  software  (IBM  Corp., 
Armonk, NY). Average, standard deviation and frequency were used as descriptive statistical 
methods. Shapiro­Wilk and Kolmogorov­Smirnov tests were used to evaluate the distribution 
of numerical data. Since the data were not suitable for normal distribution, Mann­Whitney U 
test was used to measure the difference between the groups and Willcoxon test was used to 
measure  the  temporal  process.  Bonferroni  test  was  used  to  detect  important  differences. 
Pearson Chi Square test was used for the differences between discrete variables. The results 
were evaluated at a 95% confidence interval and p <0.05 significance level.