An interventional study of ozone injection and betamethasone in Trochanteric Bursitis, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-21.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Treatment
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.
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.
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's enrollment of 63 is above the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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
1ml betamethasone will be used for steroid injection.
Drug: betamethasone
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.
Also known as: no other names
1ml betamethasone will be used for steroid injection.
Also known as: no other names
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)
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
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
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)
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
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
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)
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
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
| Milestone | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Started | 33 | 30 |
| Completed | 33 | 30 |
| Not completed | 0 | 0 |
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Pain Severity | 8.36 ± 1.06 | 8.17 ± 0.95 |
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Pain Severity | 3.64 ± 2.28 | 2.93 ± 2.27 |
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Pain Severity | 3.30 ± 3.15 | 3.00 ± 2.41 |
harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Functionality | 53.03 ± 5.87 | 53.03 ± 5.97 |
harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Functionality | 72.85 ± 12.02 | 75.00 ± 7.56 |
harris hip score: gives information about the functionality of patients. harris hip score minimum score: 0 maximum score: 100. High scores reflect better functionality
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Functionality | 72.79 ± 12.58 | 74.97 ± 6.89 |
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
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Patient Reported Quality of Life - Notthingham Health Profile | 261.72 ± 109.77 | 255.51 ± 127.22 |
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
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Patient Reported Quality of Life - Notthingham Health Profile | 215.40 ± 106.58 | 193.04 ± 103.10 |
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
| score on a scale | Ozone Injection Group | Steroid Injection Group |
|---|---|---|
| Patient Reported Quality of Life - Notthingham Health Profile | 210.28 ± 108.58 | 188.62 ± 109.10 |
Collected over adverse events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ozone Injection Group | — | — | — |
| Steroid Injection Group | — | — | — |
| Age, Categorical(Participants) | Ozone Injection Group | Steroid Injection Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 26 | 23 | 49 |
| >=65 years | 7 | 7 | 14 |
| Age, Continuous(years) | Ozone Injection Group | Steroid Injection Group | Total |
|---|---|---|---|
| Mean | 53.85 ± 11.82 | 54.87 ± 12.95 | 54.33 ± 12.28 |
| Sex: Female, Male(Participants) | Ozone Injection Group | Steroid Injection Group | Total |
|---|---|---|---|
| Female | 28 | 26 | 54 |
| Male | 5 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Ozone Injection Group | Steroid Injection Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 33 | 30 | 63 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Ozone Injection Group | Steroid Injection Group | Total |
|---|---|---|---|
| Turkey | 33 | 30 | 63 |
| Body Mass Index(kg/m^2) | Ozone Injection Group | Steroid Injection Group | Total |
|---|---|---|---|
| Mean | 26.68 ± 4.41 | 29.64 ± 4.37 | 29.14 ± 4.38 |
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey