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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.
 
ClinicalTrials.gov Identifier: NCT00480675
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 30, 2007
First Posted Date  ICMJE May 31, 2007
Last Update Posted Date January 28, 2009
Study Start Date  ICMJE March 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2007)
Numerical pain scores [ Time Frame: 1 and 3 month post-injection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00480675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2007)
SF-36, Oswestry Disability Index, Satisfaction [ Time Frame: 1 and 3 months post-injection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections
Official Title  ICMJE Not Provided
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bursitis
Intervention  ICMJE
  • Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine
    Depomedrol 60 mg + bupivacaine 2.5 ml
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Trochanteric bursa injections done into the bursa under fluoroscopic guidance
    Intervention: Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine
  • Active Comparator: 2
    Trochanteric bursa injection done with sham fluoroscopy using only landmarks as guidance.
    Intervention: Procedure: Trochanteric bursa injection with depomedrol and bupivacaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2009)
65
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2007)
64
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years
  • Clinical diagnosis of trochanteric bursitis

Exclusion Criteria:

  • Pregnancy
  • Allergy to contrast
  • Untreated coagulopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00480675
Other Study ID Numbers  ICMJE NA_00006986
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins Office of Research Administration, Amanda Gibson
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven P Cohen, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP