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Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480675
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : January 28, 2009
Information provided by:
Johns Hopkins University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Bursitis Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine Procedure: Trochanteric bursa injection with depomedrol and bupivacaine Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis

Arm Intervention/treatment
Experimental: 1
Trochanteric bursa injections done into the bursa under fluoroscopic guidance
Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine
Depomedrol 60 mg + bupivacaine 2.5 ml

Active Comparator: 2
Trochanteric bursa injection done with sham fluoroscopy using only landmarks as guidance.
Procedure: Trochanteric bursa injection with depomedrol and bupivacaine
Trochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance.

Primary Outcome Measures :
  1. Numerical pain scores [ Time Frame: 1 and 3 month post-injection ]

Secondary Outcome Measures :
  1. SF-36, Oswestry Disability Index, Satisfaction [ Time Frame: 1 and 3 months post-injection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Clinical diagnosis of trochanteric bursitis

Exclusion Criteria:

  • Pregnancy
  • Allergy to contrast
  • Untreated coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480675

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United States, Maryland
Blaustein Pain Treatment Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Steven P Cohen, MD Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johns Hopkins Office of Research Administration, Amanda Gibson Identifier: NCT00480675    
Other Study ID Numbers: NA_00006986
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009
Keywords provided by Johns Hopkins University:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Autonomic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents