Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480675
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2007-05-30
Brief Title:
Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 25 ml of 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None