Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome
Primary Purpose
Trochanteric Bursitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ozone injection
betamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Trochanteric Bursitis focused on measuring trochanteric bursitis, ozone, steroid, injection
Eligibility Criteria
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
Sites / Locations
- Sultan 2.Abdülhamid Han Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ozone injection group
steroid injection group
Arm Description
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.
1ml betamethasone will be used for steroid injection.
Outcomes
Primary Outcome Measures
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Secondary Outcome Measures
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
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
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
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
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
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
Full Information
NCT ID
NCT04420572
First Posted
June 2, 2020
Last Updated
October 5, 2021
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT04420572
Brief Title
Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome
Official Title
Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
This study is a randomized controlled prospective clinical trial. The sample size is 60 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trochanteric Bursitis
Keywords
trochanteric bursitis, ozone, steroid, injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ozone injection group
Arm Type
Experimental
Arm Description
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.
Arm Title
steroid injection group
Arm Type
Experimental
Arm Description
1ml betamethasone will be used for steroid injection.
Intervention Type
Drug
Intervention Name(s)
ozone injection
Other Intervention Name(s)
no other names
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
betamethasone
Other Intervention Name(s)
no other names
Intervention Description
1ml betamethasone will be used for steroid injection.
Primary Outcome Measure Information:
Title
Pain Severity
Description
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame
day 0 (before intervention)
Title
Pain Severity
Description
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame
1 week after intervention
Title
Pain Severity
Description
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Time Frame
1 month after intervention
Secondary Outcome Measure Information:
Title
Functionality
Description
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)
Title
Functionality
Description
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
Title
Functionality
Description
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
Title
Patient Reported Quality of Life - Notthingham Health Profile
Description
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)
Title
Patient Reported Quality of Life - Notthingham Health Profile
Description
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
Title
Patient Reported Quality of Life - Notthingham Health Profile
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADEM ERBİROL
Organizational Affiliation
sultan abdulhamid han
Official's Role
Study Director
Facility Information:
Facility Name
Sultan 2.Abdülhamid Han Training and Research Hospital
City
Istanbul
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
other researchers would get information from the main researcher. therefore it was not shared.
Learn more about this trial
Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome
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