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Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863889
First Posted: March 18, 2009
Last Update Posted: September 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas L Bradbury, MD, Emory University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Thomas L Bradbury, MD, Emory University:

Primary Outcome Measures:
  • WOMAC hip score [ Time Frame: 2 weeks, 6 weeks, 3 months ]

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

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 17, 2009
First Posted: March 18, 2009
Last Update Posted: September 23, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases
Lidocaine
Bupivacaine
Methylprednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia 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