Trochanteric BursitisNCT04420572
Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome
A study testing ozone injection and betamethasone in people with Trochanteric Bursitis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trochanteric Bursitis
- What is being tested?
- ozone injection and betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2.Abdülhamid Han Training and Research Hospital
Istanbul, Eyalet/Yerleşke, 34000
About this study
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.
Read the 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.
- Conditions
- Trochanteric Bursitis
- Being tested
- ozone injection, betamethasone
- Keywords
- trochanteric bursitis, ozone, steroid, injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone injectionDrug
Also called no other names
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.
betamethasoneDrug
Also called no other names
1ml betamethasone will be used for steroid injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ozone injection |
| steroid injection group | Experimental | 1ml betamethasone will be used for steroid injection. Receives: Drug: betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Measured: day 0 (before intervention)
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Measured: 1 week after intervention
Pain Severity
visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain
Measured: 1 month after intervention
Secondary outcomes (6)
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
Measured: day 0 (before intervention)
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
Measured: 1 week after intervention
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
Measured: 1 month after intervention
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
Measured: day 0 (before intervention)
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
Measured: 1 week after intervention
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
Measured: 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start11 Mar 2021
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trochanteric BursitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ADEM ERBİROL, Study director, sultan abdulhamid han
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420572
- Sponsor's protocol ID
- Adem Erbirol
- Status last verified
- Oct 2021
- First submitted
- 2 Jun 2020
- Last updated
- 21 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: other researchers would get information from the main researcher. therefore it was not shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome
- ClinicalTrials.gov ID
- NCT04420572
- Acronym / sponsor ID
- Adem Erbirol
- Conditions
- Trochanteric Bursitis
- Keywords
- trochanteric bursitis, ozone, steroid, injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 21 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozone injection group | Experimental | Drug: ozone injectionozone 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. |
| steroid injection group | Experimental | Drug: betamethasone1ml betamethasone will be used for steroid injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozone injectionAlso: no other namesozone 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 group |
| betamethasoneAlso: no other names1ml betamethasone will be used for steroid injection. | Drug | steroid injection group |
Primary outcome
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 week 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
6 secondary outcomes
Functionality
Time frame: day 0 (before intervention)
Functionality
Time frame: 1 week after intervention
Functionality
Time frame: 1 month after intervention
Patient Reported Quality of Life - Notthingham Health Profile
Time frame: day 0 (before intervention)
Patient Reported Quality of Life - Notthingham Health Profile
Time frame: 1 week after intervention
Patient Reported Quality of Life - Notthingham Health Profile
Time frame: 1 month after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. other researchers would get information from the main researcher. therefore it was not shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADEM ERBİROL study director
sultan abdulhamid han
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozone injection and betamethasone in people with Trochanteric Bursitis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: day 0 (before intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.