Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00480675

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

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.

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.