Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome
Primary Purpose
Bursitis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Depomedrol injection
Lidocaine, Marcaine
Sponsored by
About this trial
This is an interventional treatment trial for Bursitis
Eligibility 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
Sites / Locations
- Dr. Tom Bradbury
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
1cc Depomedrol, 4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
Outcomes
Primary Outcome Measures
WOMAC hip score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00863889
Brief Title
Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome
Official Title
Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bursitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
1cc Depomedrol, 4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
Intervention Type
Drug
Intervention Name(s)
Depomedrol injection
Intervention Description
1 cc of Depomedrol 80
Intervention Type
Drug
Intervention Name(s)
Lidocaine, Marcaine
Intervention Description
4 cc of each local anesthetic
Primary Outcome Measure Information:
Title
WOMAC hip score
Time Frame
2 weeks, 6 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Bradbury, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Tom Bradbury
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8970048
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.
Results Reference
background
PubMed Identifier
18391676
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.
Results Reference
background
PubMed Identifier
17880718
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. doi: 10.1186/1471-2474-8-95.
Results Reference
background
PubMed Identifier
17681203
Citation
Baker CL Jr, Massie RV, Hurt WG, Savory CG. Arthroscopic bursectomy for recalcitrant trochanteric bursitis. Arthroscopy. 2007 Aug;23(8):827-32. doi: 10.1016/j.arthro.2007.02.015. Epub 2007 Jun 14.
Results Reference
background
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Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome
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