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Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections

Primary Purpose

Bursitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine
Trochanteric bursa injection with depomedrol and bupivacaine
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bursitis focused on measuring bursitis, injection, fluoroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • Clinical diagnosis of trochanteric bursitis

Exclusion Criteria:

  • Pregnancy
  • Allergy to contrast
  • Untreated coagulopathy

Sites / Locations

  • Blaustein Pain Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Trochanteric bursa injections done into the bursa under fluoroscopic guidance

Trochanteric bursa injection done with sham fluoroscopy using only landmarks as guidance.

Outcomes

Primary Outcome Measures

Numerical pain scores

Secondary Outcome Measures

SF-36, Oswestry Disability Index, Satisfaction

Full Information

First Posted
May 30, 2007
Last Updated
January 27, 2009
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00480675
Brief Title
Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bursitis
Keywords
bursitis, injection, fluoroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Trochanteric bursa injections done into the bursa under fluoroscopic guidance
Arm Title
2
Arm Type
Active Comparator
Arm Description
Trochanteric bursa injection done with sham fluoroscopy using only landmarks as guidance.
Intervention Type
Procedure
Intervention Name(s)
trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine
Intervention Description
Depomedrol 60 mg + bupivacaine 2.5 ml
Intervention Type
Procedure
Intervention Name(s)
Trochanteric bursa injection with depomedrol and bupivacaine
Intervention Description
Trochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance.
Primary Outcome Measure Information:
Title
Numerical pain scores
Time Frame
1 and 3 month post-injection
Secondary Outcome Measure Information:
Title
SF-36, Oswestry Disability Index, Satisfaction
Time Frame
1 and 3 months post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years Clinical diagnosis of trochanteric bursitis Exclusion Criteria: Pregnancy Allergy to contrast Untreated coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Cohen, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blaustein Pain Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15516348
Citation
Cohen SP, Narvaez JC, Lebovits AH, Stojanovic MP. Corticosteroid injections for trochanteric bursitis: is fluoroscopy necessary? A pilot study. Br J Anaesth. 2005 Jan;94(1):100-6. doi: 10.1093/bja/aei012. Epub 2004 Oct 29.
Results Reference
background
PubMed Identifier
3778178
Citation
Schapira D, Nahir M, Scharf Y. Trochanteric bursitis: a common clinical problem. Arch Phys Med Rehabil. 1986 Nov;67(11):815-7.
Results Reference
background
PubMed Identifier
19366755
Citation
Cohen SP, Strassels SA, Foster L, Marvel J, Williams K, Crooks M, Gross A, Kurihara C, Nguyen C, Williams N. Comparison of fluoroscopically guided and blind corticosteroid injections for greater trochanteric pain syndrome: multicentre randomised controlled trial. BMJ. 2009 Apr 14;338:b1088. doi: 10.1136/bmj.b1088.
Results Reference
derived

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Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections

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