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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: November 20, 2020

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.

The study is planned to be done between 20/06/2020 – 15/10/2020. This study is a randomized controlled prospective clinical trial. The sample size is 60 patients.

Interventions

  • 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.
  • Drug: betamethasone
    • 1ml betamethasone will be used for steroid injection.

Arms, Groups and Cohorts

  • 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.
  • Experimental: steroid injection group
    • 1ml betamethasone will be used for steroid injection.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • functionality
    • Time Frame: 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
  • functionality
    • Time Frame: 1 hour 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
  • functionality
    • Time Frame: 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
  • Patient Reported Quality of Life
    • Time Frame: 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
  • Patient Reported Quality of Life
    • Time Frame: 1 hour 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
  • Patient Reported Quality of Life
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ADEM ERBİROL, Study Director, sultan abdulhamid han
  • Overall Contact(s)
    • ADEM ERBİROL, +905426608788, aerbirol@hotmail.com

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