BursitisNCT00480675
Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections
A study testing trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine and Trochanteric bursa injection with depomedrol and bupivacaine in people with Bursitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goals of our research project are to study the relationship, if any, between the success of a TB injection (measured by pain relief and general patient satisfaction) and the method in which it was placed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bursitis
- What is being tested?
- trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine and Trochanteric bursa injection with depomedrol and bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Clinical diagnosis of trochanteric bursitis
Who cannot join
- Pregnancy
- Allergy to contrast
- Untreated coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Blaustein Pain Treatment Center
Baltimore, Maryland, 21205
About this study
The goals of our research project are to study the relationship, if any, between the success of a TB injection (measured by pain relief and general patient satisfaction) and the method in which it was placed. Because fluoroscopy places patients requires a slight risk from radiation exposure and increased cost versus blind injection, it is important to know if there is an advantage to using this technique. The investigators will randomize 64 patients to receive either trochanteric bursa injections with corticosteroid and local anesthetic guided by fluoroscopy, or trochanteric bursa patients to receive trochanteric bursa injections based on landmarks on palpation. The investigators will then determine which method is superior, and whether injecting steroid and local anesthetic into the bursa itself is superior or inferior to injecting it into a tender area outside the bursa.
Read the detailed description
This will be a randomized, controlled study evaluating the value of fluoroscopy in trochanteric bursa injections. Subjects will be recruited solely from the patients we normally see at the Blaustein Pain Treatment Center with a clinical diagnosis of GTPS. Sixty-four patients will be randomized in a 1:1 ratio using sealed envelopes to receive either TB corticosteroid injection done blind or with fluoroscopy. All patients who provide informed consent will be brought into the fluoroscopy suite and placed in the lateral decubitus position. In the patients randomized to receive fluoroscopically guided injections, a 22-gauge needle will be placed into the TB and correct position confirmed by fluoroscopy and contrast injection (1 ml per attempt) before corticosteroid and local anesthetic injection (60 mg of depomedrol and 2.5 ml of 0.5% bupivacaine). In the blinded group, one sham, pulsed fluoroscopic image will be taken of the femur, and the injection will be done based only on physical exam (overlying the area of maximal tenderness) and landmarks. Prior to the injection, 1 ml of contrast will be administered and another image taken to determine whether or not the needle is within the bursa, but this will not alter the injection. After contrast administration, the same corticosteroid and bupivacaine injection will be administered. The 2 main questions we propose to answer are: 1) whether using fluoroscopy for TB injections results in improved outcomes (comparison of the 32 patients in each group); and 2) whether injecting into the bursa provides superior results than performing non-bursal injections into the area of maximal tenderness (comparison of 32 patients who receive fluoroscopically-guided bursa injections + those patients whose blinded injection was noted to be intra-bursal vs. those patients whose blinded injection was extra-bursal).
- Conditions
- Bursitis
- Being tested
- trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine, Trochanteric bursa injection with depomedrol and bupivacaine
- Keywords
- bursitis, injection, fluoroscopy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaineProcedure or surgery
Depomedrol 60 mg + bupivacaine 2.5 ml
Trochanteric bursa injection with depomedrol and bupivacaineProcedure or surgery
Trochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Trochanteric bursa injections done into the bursa under fluoroscopic guidance Receives: Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine |
| 2 | Active comparator | Trochanteric bursa injection done with sham fluoroscopy using only landmarks as guidance. Receives: Procedure: Trochanteric bursa injection with depomedrol and bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain scores
Measured: 1 and 3 month post-injection
Secondary outcomes (1)
SF-36, Oswestry Disability Index, Satisfaction
Measured: 1 and 3 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BursitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Steven P Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480675
- Sponsor's protocol ID
- NA_00006986
- Status last verified
- Jan 2009
- First submitted
- 30 May 2007
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen SP, Narvaez JC, Lebovits AH, Stojanovic MP. Corticosteroid injections for trochanteric bursitis: is fluoroscopy necessary? A pilot study. Br J Anaesth. 2005 Jan;94(1):100-6. doi: 10.1093/bja/aei012. Epub 2004 Oct 29.
PubMed 15516348Schapira D, Nahir M, Scharf Y. Trochanteric bursitis: a common clinical problem. Arch Phys Med Rehabil. 1986 Nov;67(11):815-7.
PubMed 3778178Cohen SP, Strassels SA, Foster L, Marvel J, Williams K, Crooks M, Gross A, Kurihara C, Nguyen C, Williams N. Comparison of fluoroscopically guided and blind corticosteroid injections for greater trochanteric pain syndrome: multicentre randomised controlled trial. BMJ. 2009 Apr 14;338:b1088. doi: 10.1136/bmj.b1088.
PubMed 19366755
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections
- ClinicalTrials.gov ID
- NCT00480675
- Acronym / sponsor ID
- NA_00006986
- Conditions
- Bursitis
- Keywords
- bursitis, injection, fluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 31 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of our research project are to study the relationship, if any, between the success of a TB injection (measured by pain relief and general patient satisfaction) and the method in which it was placed. Because fluoroscopy places patients requires a slight risk from radiation exposure and increased cost versus blind injection, it is important to know if there is an advantage to using this technique. The investigators will randomize 64 patients to receive either trochanteric bursa injections with corticosteroid and local anesthetic guided by fluoroscopy, or trochanteric bursa patients to receive trochanteric bursa injections based on landmarks on palpation. The investigators will then determine which method is superior, and whether injecting steroid and local anesthetic into the bursa itself is superior or inferior to injecting it into a tender area outside the bursa.
Detailed description
This will be a randomized, controlled study evaluating the value of fluoroscopy in trochanteric bursa injections. Subjects will be recruited solely from the patients we normally see at the Blaustein Pain Treatment Center with a clinical diagnosis of GTPS. Sixty-four patients will be randomized in a 1:1 ratio using sealed envelopes to receive either TB corticosteroid injection done blind or with fluoroscopy. All patients who provide informed consent will be brought into the fluoroscopy suite and placed in the lateral decubitus position. In the patients randomized to receive fluoroscopically guided injections, a 22-gauge needle will be placed into the TB and correct position confirmed by fluoroscopy and contrast injection (1 ml per attempt) before corticosteroid and local anesthetic injection (60 mg of depomedrol and 2.5 ml of 0.5% bupivacaine). In the blinded group, one sham, pulsed fluoroscopic image will be taken of the femur, and the injection will be done based only on physical exam (overlying the area of maximal tenderness) and landmarks. Prior to the injection, 1 ml of contrast will be administered and another image taken to determine whether or not the needle is within the bursa, but this will not alter the injection. After contrast administration, the same corticosteroid and bupivacaine injection will be administered. The 2 main questions we propose to answer are: 1) whether using fluoroscopy for TB injections results in improved outcomes (comparison of the 32 patients in each group); and 2) whether injecting into the bursa provides superior results than performing non-bursal injections into the area of maximal tenderness (comparison of 32 patients who receive fluoroscopically-guided bursa injections + those patients whose blinded injection was noted to be intra-bursal vs. those patients whose blinded injection was extra-bursal).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaineTrochanteric bursa injections done into the bursa under fluoroscopic guidance |
| 2 | Active comparator | Procedure: Trochanteric bursa injection with depomedrol and bupivacaineTrochanteric bursa injection done with sham fluoroscopy using only landmarks as guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Clinical diagnosis of trochanteric bursitis
Key exclusion criteria (3 listed)
- Pregnancy
- Allergy to contrast
- Untreated coagulopathy
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 |
|---|---|---|
| trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaineDepomedrol 60 mg + bupivacaine 2.5 ml | Procedure or surgery | 1 |
| Trochanteric bursa injection with depomedrol and bupivacaineTrochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance. | Procedure or surgery | 2 |
Primary outcome
Numerical pain scores
Time frame: 1 and 3 month post-injection
1 secondary outcome
SF-36, Oswestry Disability Index, Satisfaction
Time frame: 1 and 3 months post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
- Background: PubMed 15516348Cohen SP, Narvaez JC, Lebovits AH, Stojanovic MP. Corticosteroid injections for trochanteric bursitis: is fluoroscopy necessary? A pilot study. Br J Anaesth. 2005 Jan;94(1):100-6. doi: 10.1093/bja/aei012. Epub 2004 Oct 29.
- Background: PubMed 3778178Schapira D, Nahir M, Scharf Y. Trochanteric bursitis: a common clinical problem. Arch Phys Med Rehabil. 1986 Nov;67(11):815-7.
- Derived from this study: PubMed 19366755Cohen SP, Strassels SA, Foster L, Marvel J, Williams K, Crooks M, Gross A, Kurihara C, Nguyen C, Williams N. Comparison of fluoroscopically guided and blind corticosteroid injections for greater trochanteric pain syndrome: multicentre randomised controlled trial. BMJ. 2009 Apr 14;338:b1088. doi: 10.1136/bmj.b1088.
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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.
Steven P Cohen, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine and Trochanteric bursa injection with depomedrol and bupivacaine in people with Bursitis, run by Johns Hopkins 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 2 inclusion and 3 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 28 Jan 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical pain scores (time frame: 1 and 3 month post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480675, which also lists 3 linked publications.
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 28 Jan 2009.