Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome

Status: Withdrawn
Study State Date: March 2009
Primary Completion Date: Actual February 2010
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Phase: Phase 4

Sponsor(s):
Emory University
 
Information By: Emory University
Trial Identifier: NCT00863889
Official Title: Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial

Description:  The objective of this study is to conduct a randomized, single-blinded placebo controlled trial comparing two modalities for the treatment of pain and mobility associated with trochanteric bursitis: (1) injection of glucocorticosteroid and local anesthetic, (2) injection of local anesthetic. We hope to determine whether steroid injections provide a statistically significant improvement in pain symptoms and hip mobility in subjects with trochanteric bursitis, as compared to an injection of local anesthetic. Our null hypothesis is that no statistically significant difference exists between the two treatment modalities.

+ Additional Objectives Detail

Trochanteric bursitis is an inflammation of the bursal sac overlying the greater trochanter of the femur. The etiology of this disease is unknown, but it is clinically characterized by chronic aching pain over the lateral aspect of the hip, which can be exacerbated by certain movements such as external rotation and abduction (2). In order to objectively determine the level of pain and mobility associated with trochanteric bursitis, some orthopaedic surgeons use scoring systems (a qualitative and quantitative scoring test) to assess patients (4). In our practice, trochanteric bursitis has been treated by injection of glucocorticosteroids (steroids) combined with local anesthetic at the site of the greater trochanter (1). Additionally, it has been found that increasing steroid dosage provides a greater level of relief (3). Although steroids are usually an effective treatment, no studies to date have compared steroid injections for relief of trochanteric bursitis pain and mobility versus a placebo injection or local anesthetic injection alone.



Accepts Healthy Volunteers?: No
Minimum Age: 17 Years
Maximum Age: N/A
Gender(s): Both
Additional Criteria:  Inclusion Criteria: - Adult patients with tenderness at the greater trochanter Exclusion Criteria: - Subjects < 17 years of age - Subjects with previous surgery to the greater trochanter - Subjects allergic to Lidocaine, Marcaine, or Depomedrol

Conditions:
Bursitis
Interventions:
Drug: Depomedrol injection
Drug: Lidocaine, Marcaine
 
Primary Outcome Measures:
WOMAC hip score
Time Frame: 2 weeks, 6 weeks, 3 months
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

1: Experimental
1cc Depomedrol, 4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
Drug: Depomedrol injection
1 cc of Depomedrol 80

 
2: Placebo Comparator
4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
Drug: Lidocaine, Marcaine
4 cc of each local anesthetic

 


Investigators:
Principal Investigator: Tom Bradbury, MD, Emory University


Study Locations:
+ Show All 1 Study Locations


United States, Georgia
Dr. Tom Bradbury 
Atlanta, Georgia, United States

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