Clinical trial NCT00480675: Randomized Study Comparing Fluoroscopically-Guided Versus Blinded Trochanteric Bursa Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bursitis
Keywords: bursitis
injection
fluoroscopy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2007-05-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Clinical diagnosis of trochanteric bursitis

Exclusion Criteria:

* Pregnancy
* Allergy to contrast
* Untreated coagulopathy

Primary outcomes:
measure: Numerical pain scores
timeFrame: 1 and 3 month post-injection
Secondary outcomes:
measure: SF-36, Oswestry Disability Index, Satisfaction
timeFrame: 1 and 3 months post-injection
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Blaustein Pain Treatment Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven P Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Schapira D, Nahir M, Scharf Y. Trochanteric bursitis: a common clinical problem. Arch Phys Med Rehabil. 1986 Nov;67(11):815-7.
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.