Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome

Bursitis Clinical Trial

Official title:

Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00863889
• Other study ID #: IRB00010776
• Status: Withdrawn
• Phase: Phase 4
• First received: March 17, 2009
• Last updated: September 19, 2013
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bursitis

Intervention

Drug:
• Depomedrol injection
1 cc of Depomedrol 80
• Lidocaine, Marcaine
4 cc of each local anesthetic

Locations

Country	Name	City	State
United States	Dr. Tom Bradbury	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Baker CL Jr, Massie RV, Hurt WG, Savory CG. Arthroscopic bursectomy for recalcitrant trochanteric bursitis. Arthroscopy. 2007 Aug;23(8):827-32. Epub 2007 Jun 14. — View Citation

Brinks A, van Rijn RM, Bohnen AM, Slee GL, Verhaar JA, Koes BW, Bierma-Zeinstra SM. Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice. BMC Musculoskelet Disord. 2007 Sep 19;8:95. — View Citation

Shbeeb MI, O'Duffy JD, Michet CJ Jr, O'Fallon WM, Matteson EL. Evaluation of glucocorticosteroid injection for the treatment of trochanteric bursitis. J Rheumatol. 1996 Dec;23(12):2104-6. — View Citation

Silva F, Adams T, Feinstein J, Arroyo RA. Trochanteric bursitis: refuting the myth of inflammation. J Clin Rheumatol. 2008 Apr;14(2):82-6. doi: 10.1097/RHU.0b013e31816b4471. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC hip score		2 weeks, 6 weeks, 3 months	No

External Links

•   Patient education on Trochanteric Bursitis