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| Sponsor: | Johns Hopkins University |
|---|---|
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00480675 |
Purpose
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 | Intervention |
|---|---|
|
Bursitis |
Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine Procedure: Trochanteric bursa injection with depomedrol and bupivacaine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Enrollment: | 65 |
| Study Start Date: | March 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
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2: Active Comparator
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.
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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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Blaustein Pain Treatment Center | |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Steven P Cohen, MD | Johns Hopkins Medical Institutions |
More Information
| Responsible Party: | Amanda Gibson ( Johns Hopkins Office of Research Administration ) |
| Study ID Numbers: | NA_00006986 |
| Study First Received: | May 30, 2007 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00480675 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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bursitis injection fluoroscopy |
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Anti-Inflammatory Agents Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anesthetics Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal |
Joint Diseases Gastrointestinal Agents Central Nervous System Depressants Methylprednisolone acetate Protective Agents Glucocorticoids Anesthetics, Local Pharmacologic Actions Autonomic Agents Prednisolone Bupivacaine Peripheral Nervous System Agents Central Nervous System Agents Bursitis |
