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

NCT04420572 | Completed Results

• 1 other identifier: Adem Erbirol
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Trochanteric Bursitis

Keywords

trochanteric bursitis; ozone; steroid; injection

Outcome Measures

Primary Outcomes (3)

• Pain Severity

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

  day 0 (before intervention)

• Pain Severity

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

  1 week after intervention

• Pain Severity

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

  1 month after intervention

Secondary Outcomes (6)

• Functionality

  day 0 (before intervention)

• Functionality

  1 week after intervention

• Functionality

  1 month after intervention

• Patient Reported Quality of Life - Notthingham Health Profile

  day 0 (before intervention)

• Patient Reported Quality of Life - Notthingham Health Profile

  1 week after intervention

Study Arms (2)

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.

Drug: ozone injection

steroid injection group

EXPERIMENTAL

1ml betamethasone will be used for steroid injection.

Drug: betamethasone

Interventions

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.

Also known as: no other names

ozone injection group

betamethasone DRUG

1ml betamethasone will be used for steroid injection.

Also known as: no other names

steroid injection group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2.Abdülhamid Han Training and Research Hospital

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

Location

MeSH Terms

Interventions

Ozone; Betamethasone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Adem Erbirol
• Organization: SultanAbdulhamid

aerbirol@hotmail.com

+905426608788

Study Officials

• ADEM ERBİROL

  sultan abdulhamid han

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: March 11, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 21, 2021
• Results First Posted: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)