BursitisNCT02221817
Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis
A study testing Trochanter bursa injections and Ultrasound in people with Bursitis, run by West Virginia University at 1 site in United States.
Trial summary
Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Bursitis
- What is being tested?
- Trochanter bursa injections and Ultrasound
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 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 to 100 years
- 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 (IRB) approved informed consent form
Who cannot join
- Allergy to triamcinolone or bupivicaine
- 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 Trial of Ultrasound Guided and Blind Corticosteroid Injection for Trochanteric Bursitis
Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter.
The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa, though this has not been confirmed. Accordingly, the use of corticosteroid injections has been shown to provide considerable relief. However, routine "blind" injections, those performed without the aid of imaging, such as fluoroscopy, have shown limited success in the appropriate needle placement. Fortunately, blind injections have yielded positive results in majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical outcome for trochanter bursa injections.
Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such as ultrasound have not been studied and may be more useful. Fluoroscopy allows for bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue structures such as the bursa and has gained significant support for use in musculoskeletal injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an ultrasound guided injection and whether ultrasound should be routinely used during trochanter bursa injections.
- Conditions
- Bursitis
- Being tested
- Trochanter bursa injections, Ultrasound
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trochanter bursa injectionsProcedure or surgery
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Blind | Active comparator | Trochanter injection Receives: Procedure: Trochanter bursa injections |
| Ultrasound | Experimental | Trochanter injection Receives: Procedure: Trochanter bursa injections; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured on Visual Analog Scale (VAS)
Measured: 3 month
Secondary outcomes (3)
Disability Measured on Becks Disability Scale
Measured: Baseline, 2 weeks, 3 month
Adverse Effects
Measured: 2 weeks, 3 month
Pain Improvement
Percent improvement
Measured: 2 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 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
- NCT02221817
- Sponsor's protocol ID
- 1407358564
- Status last verified
- Sep 2021
- First submitted
- 16 Aug 2014
- Last updated
- 20 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 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Ultrasound Guided and Blind Corticosteroid Injection for Trochanteric Bursitis
- ClinicalTrials.gov ID
- NCT02221817
- Acronym / sponsor ID
- 1407358564
- Conditions
- Bursitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Aug 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.
Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter.
The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa, though this has not been confirmed. Accordingly, the use of corticosteroid injections has been shown to provide considerable relief. However, routine "blind" injections, those performed without the aid of imaging, such as fluoroscopy, have shown limited success in the appropriate needle placement. Fortunately, blind injections have yielded positive results in majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical outcome for trochanter bursa injections.
Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such as ultrasound have not been studied and may be more useful. Fluoroscopy allows for bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue structures such as the bursa and has gained significant support for use in musculoskeletal injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an ultrasound guided injection and whether ultrasound should be routinely used during trochanter bursa injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blind | Active comparator | Procedure: Trochanter bursa injectionsTrochanter injection |
| Ultrasound | Experimental | Procedure: Trochanter bursa injections, Device: UltrasoundTrochanter injection |
Who may qualify
- Ages
- 18 to 100 years
- 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 (IRB) approved informed consent form
Key exclusion criteria (4 listed)
- Allergy to triamcinolone or bupivicaine
- 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
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 |
|---|---|---|
| Trochanter bursa injections | Procedure or surgery | Blind, Ultrasound |
| Ultrasound | Device | Ultrasound |
Primary outcome
Pain Intensity Measured on Visual Analog Scale (VAS)
Time frame: 3 month
3 secondary outcomes
Disability Measured on Becks Disability Scale
Time frame: Baseline, 2 weeks, 3 month
Adverse Effects
Time frame: 2 weeks, 3 month
Pain Improvement
Time frame: 2 weeks, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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 Trochanter bursa injections and Ultrasound 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 4 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 20 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 (VAS) (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 20 Oct 2021.