BursitisNCT02126878
Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
A study testing Kenalog in people with Bursitis, run by West Virginia University at 1 site in United States.
Trial summary
Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bursitis
- What is being tested?
- Kenalog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of trochanteric bursitis
- 18 years of age or older when written informed consent is obtained
- Signed institutional review board approved informed consent form
Who cannot join
- Meets any contraindication for treatment
- Allergy to triamcinolone, lidocaine
- Previous surgery to bursa
- Coagulopathy
- Active Infection
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospitals
Morgantown, West Virginia, 26505
About this study
Official title: Prospective, Randomized, Double-blinded Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local steroid injection. The injection consists of a mixture of local anesthetic and steroid medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to diluent the steroid as well as act as a pain reliever. Various steroid preparations have been used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is commonly used for various reasons. Besides the procedure associated and injection site risks, risks associated with the use of steroids, though rare, exist. Short term, the steroid can raise blood sugar levels and should be used with caution and be appropriately monitored in diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are related to the dose and frequency of use. These risks include thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and joints. Studies have shown the effectiveness of local steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the effectiveness of local steroid injections of various steroid dosages for the treatment of trochanteric bursitis.
- Conditions
- Bursitis
- Being tested
- Kenalog
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KenalogDrug
| Study group | Role | What they receive |
|---|---|---|
| Kenalog 20mg | Active comparator | 20mg/ 2ml and local anesthetic Receives: Drug: Kenalog |
| Kenalog 40mg | Active comparator | 40mg/ 2ml with local anesthetic Receives: Drug: Kenalog |
| Kenalog 80mg | Active comparator | 80mg/ 2ml and local anesthetic Receives: Drug: Kenalog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured on Visual Analog Scale and Percent Improvement
Measured: 3 month
Secondary outcomes (2)
Disability Measured on Becks Disability Scale
Measured: Baseline, 1 month, 3 month
Safety, Adverse Affects
Measured: 1 month,3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
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 BursitisStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126878
- Sponsor's protocol ID
- 1401174207
- Status last verified
- Sep 2021
- First submitted
- 26 Apr 2014
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blinded Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
- ClinicalTrials.gov ID
- NCT02126878
- Acronym / sponsor ID
- 1401174207
- Conditions
- Bursitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local steroid injection. The injection consists of a mixture of local anesthetic and steroid medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to diluent the steroid as well as act as a pain reliever. Various steroid preparations have been used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is commonly used for various reasons. Besides the procedure associated and injection site risks, risks associated with the use of steroids, though rare, exist. Short term, the steroid can raise blood sugar levels and should be used with caution and be appropriately monitored in diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are related to the dose and frequency of use. These risks include thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and joints. Studies have shown the effectiveness of local steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the effectiveness of local steroid injections of various steroid dosages for the treatment of trochanteric bursitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kenalog 20mg | Active comparator | Drug: Kenalog20mg/ 2ml and local anesthetic |
| Kenalog 40mg | Active comparator | Drug: Kenalog40mg/ 2ml with local anesthetic |
| Kenalog 80mg | Active comparator | Drug: Kenalog80mg/ 2ml and local anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of trochanteric bursitis
- 18 years of age or older when written informed consent is obtained
- Signed institutional review board approved informed consent form
Key exclusion criteria (6 listed)
- Meets any contraindication for treatment
- Allergy to triamcinolone, lidocaine
- Previous surgery to bursa
- Coagulopathy
- Active Infection
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 |
|---|---|---|
| Kenalog | Drug | Kenalog 20mg, Kenalog 40mg, Kenalog 80mg |
Primary outcome
Pain Intensity Measured on Visual Analog Scale and Percent Improvement
Time frame: 3 month
2 secondary outcomes
Disability Measured on Becks Disability Scale
Time frame: Baseline, 1 month, 3 month
Safety, Adverse Affects
Time frame: 1 month,3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kenalog in people with Bursitis, run by West Virginia University at 1 site in United States.
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 3 inclusion and 6 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 19 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 United States. 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 20 Jan 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 Intensity Measured on Visual Analog Scale and Percent Improvement (time frame: 3 month). 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 19 Oct 2021.