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临床试验/NCT04420572
NCT04420572已完成不适用

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年3月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Pain Severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

double

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years of age, under 75 years of age
  • Lateral hip pain
  • Having pain for at least 3 months
  • The VAS value should be minimum 4 and pain is increased by pressing on t.major.
  • Conservative treatment failure

排除标准

  • Motor and / or sensory impairment compatible with radiculopathy
  • Connective tissue disease
  • Active infection, immune system disorders, unresolved fractures
  • Hip op history, bursectomy / ilio-tibial band elongation
  • Steroid injection history in the past 4 months
  • Physical therapy history for trochanteric bursitis in the last 4 months
  • Rheumatological patients, pregnancy, Patients with a history of cancer

研究组 & 干预措施

ozone injection group

Experimental

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.

干预措施: ozone injection (Drug)

steroid injection group

Experimental

1ml betamethasone will be used for steroid injection.

干预措施: betamethasone (Drug)

结局指标

主要结局

Pain Severity

时间窗: 1 month after intervention

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

次要结局

  • Functionality(1 month after intervention)
  • Patient Reported Quality of Life - Notthingham Health Profile(1 month after intervention)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Sponsor

研究点 (1)

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