NCT00863889

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 23, 2013

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

March 17, 2009

Last Update Submit

September 19, 2013

Conditions

Bursitis

Outcome Measures

Primary Outcomes (1)

  • WOMAC hip score

    2 weeks, 6 weeks, 3 months

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Depomedrol injection

2

PLACEBO COMPARATOR

4 cc 1% Lidocaine, 4 cc 0.25% Marcaine

Drug: Lidocaine, Marcaine

Interventions

Depomedrol injectionDRUG

1 cc of Depomedrol 80

1
Lidocaine, MarcaineDRUG

4 cc of each local anesthetic

2

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with tenderness at the greater trochanter

You may not qualify if:

  • Subjects \< 17 years of age
  • Subjects with previous surgery to the greater trochanter
  • Subjects allergic to Lidocaine, Marcaine, or Depomedrol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Tom Bradbury

Atlanta, Georgia, 30306, United States

Location

Related Publications (4)

  • 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.

    PMID: 8970048BACKGROUND

  • 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.

    PMID: 18391676BACKGROUND

  • 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.

    PMID: 17880718BACKGROUND

  • 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.

    PMID: 17681203BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

LidocaineBupivacaine

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Tom Bradbury, MD

    Emory University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Residency Program Director

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 23, 2013

Record last verified: 2013-09

Locations

US(1)