Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Thomas L Bradbury, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00863889
First received: March 17, 2009
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Bursitis
Drug: Depomedrol injection
Drug: Lidocaine, Marcaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • WOMAC hip score [ Time Frame: 2 weeks, 6 weeks, 3 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1cc Depomedrol, 4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
Drug: Depomedrol injection
1 cc of Depomedrol 80
Placebo Comparator: 2
4 cc 1% Lidocaine, 4 cc 0.25% Marcaine
Drug: Lidocaine, Marcaine
4 cc of each local anesthetic

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00863889

Locations
United States, Georgia
Dr. Tom Bradbury
Atlanta, Georgia, United States, 30306
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Tom Bradbury, MD Emory University
  More Information

Additional Information:
Publications:
Responsible Party: Thomas L Bradbury, MD, Residency Program Director, Emory University
ClinicalTrials.gov Identifier: NCT00863889     History of Changes
Other Study ID Numbers: IRB00010776
Study First Received: March 17, 2009
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lidocaine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014