Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections

Bursitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480675
• Other study ID #: NA_00006986
• Status: Completed
• Phase: N/A
• First received: May 30, 2007
• Last updated: January 27, 2009
• Start date: March 2007
• Est. completion date: May 2008

Study information

• Verified date: January 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Clinical diagnosis of trochanteric bursitis

Exclusion Criteria:

• Pregnancy

• Allergy to contrast

• Untreated coagulopathy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis

Intervention

Procedure:
• trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine
Depomedrol 60 mg + bupivacaine 2.5 ml
• 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.

Locations

Country	Name	City	State
United States	Blaustein Pain Treatment Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2004 Oct 29. — View Citation

Schapira D, Nahir M, Scharf Y. Trochanteric bursitis: a common clinical problem. Arch Phys Med Rehabil. 1986 Nov;67(11):815-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical pain scores		1 and 3 month post-injection	No
Secondary	SF-36, Oswestry Disability Index, Satisfaction		1 and 3 months post-injection	No