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Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00480675
First received: May 30, 2007
Last updated: January 27, 2009
Last verified: January 2009
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Numerical pain scores [ Time Frame: 1 and 3 month post-injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36, Oswestry Disability Index, Satisfaction [ Time Frame: 1 and 3 months post-injection ] [ Designated as safety issue: No ]

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
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Clinical diagnosis of trochanteric bursitis

Exclusion Criteria:

  • Pregnancy
  • Allergy to contrast
  • Untreated coagulopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480675

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins Office of Research Administration, Amanda Gibson
ClinicalTrials.gov Identifier: NCT00480675     History of Changes
Other Study ID Numbers: NA_00006986
Study First Received: May 30, 2007
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
bursitis
injection
fluoroscopy

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases
Bupivacaine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics
Anesthetics, Local
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents

ClinicalTrials.gov processed this record on November 24, 2014