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Steroid Injection for the Treatment of Greater Trochanteric Pain Syndrome

NCT ID: NCT00863889

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Bursitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

1cc Depomedrol, 4 cc 1% Lidocaine, 4 cc 0.25% Marcaine

Group Type EXPERIMENTAL

Depomedrol injection

Intervention Type DRUG

1 cc of Depomedrol 80

2

4 cc 1% Lidocaine, 4 cc 0.25% Marcaine

Group Type PLACEBO_COMPARATOR

Lidocaine, Marcaine

Intervention Type DRUG

4 cc of each local anesthetic

Interventions

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Depomedrol injection

1 cc of Depomedrol 80

Intervention Type DRUG

Lidocaine, Marcaine

4 cc of each local anesthetic

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Thomas L Bradbury, MD

Residency Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Bradbury, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Dr. Tom Bradbury

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8970048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18391676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17880718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17681203 (View on PubMed)

Other Identifiers

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IRB00010776

Identifier Type: -

Identifier Source: org_study_id