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NCT Number: NCT04420572

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

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.

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Key information

Conditions

Trochanteric Bursitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan 2.Abdülhamid Han Training and Research Hospital

Istanbul, Eyalet/Yerleşke, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Motor and / or sensory impairment compatible with radiculopathy
  • Connective tissue disease
  • Pregnancy
  • 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

Treatment and study plan

ozone injection

Drug

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.

Other names: no other names

Betamethasone

Drug

1ml betamethasone will be used for steroid injection.

Other names: no other names

Primary outcomes

  1. 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

  2. Pain Severity

    Time frame: 1 week after intervention

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

  3. 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 outcomes

  1. 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

  2. Functionality

    Time frame: 1 week 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

  3. 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

  4. Patient Reported Quality of Life - Notthingham Health Profile

    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

  5. Patient Reported Quality of Life - Notthingham Health Profile

    Time frame: 1 week 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

  6. Patient Reported Quality of Life - Notthingham Health Profile

    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

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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