NCT00480675

Brief Summary

The goals of our research project are to study the relationship, if any, between the success of a TB injection (measured by pain relief and general patient satisfaction) and the method in which it was placed. Because fluoroscopy places patients requires a slight risk from radiation exposure and increased cost versus blind injection, it is important to know if there is an advantage to using this technique. The investigators will randomize 64 patients to receive either trochanteric bursa injections with corticosteroid and local anesthetic guided by fluoroscopy, or trochanteric bursa patients to receive trochanteric bursa injections based on landmarks on palpation. The investigators will then determine which method is superior, and whether injecting steroid and local anesthetic into the bursa itself is superior or inferior to injecting it into a tender area outside the bursa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

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, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

1.2 years

First QC Date

May 30, 2007

Last Update Submit

January 27, 2009

Conditions

Bursitis

Keywords

bursitisinjectionfluoroscopy

Outcome Measures

Primary Outcomes (1)

  • Numerical pain scores

    1 and 3 month post-injection

Secondary Outcomes (1)

  • SF-36, Oswestry Disability Index, Satisfaction

    1 and 3 months post-injection

Study Arms (2)

1

EXPERIMENTAL

Trochanteric bursa injections done into the bursa under fluoroscopic guidance

Procedure: trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacaine

2

ACTIVE COMPARATOR

Trochanteric bursa injection done with sham fluoroscopy using only landmarks as guidance.

Procedure: Trochanteric bursa injection with depomedrol and bupivacaine

Interventions

trochanteric bursa injection done under fluoroscopy with depomedrol and bupivacainePROCEDURE

Depomedrol 60 mg + bupivacaine 2.5 ml

1
Trochanteric bursa injection with depomedrol and bupivacainePROCEDURE

Trochanteric bursa injection done with sham x-ray and 60 mg of depomedroal and 2.5 ml bupivacaine using landmarks for guidance.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Clinical diagnosis of trochanteric bursitis

You may not qualify if:

  • Pregnancy
  • Allergy to contrast
  • Untreated coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blaustein Pain Treatment Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • Cohen SP, Narvaez JC, Lebovits AH, Stojanovic MP. Corticosteroid injections for trochanteric bursitis: is fluoroscopy necessary? A pilot study. Br J Anaesth. 2005 Jan;94(1):100-6. doi: 10.1093/bja/aei012. Epub 2004 Oct 29.

    PMID: 15516348BACKGROUND

  • Schapira D, Nahir M, Scharf Y. Trochanteric bursitis: a common clinical problem. Arch Phys Med Rehabil. 1986 Nov;67(11):815-7.

    PMID: 3778178BACKGROUND

  • Cohen SP, Strassels SA, Foster L, Marvel J, Williams K, Crooks M, Gross A, Kurihara C, Nguyen C, Williams N. Comparison of fluoroscopically guided and blind corticosteroid injections for greater trochanteric pain syndrome: multicentre randomised controlled trial. BMJ. 2009 Apr 14;338:b1088. doi: 10.1136/bmj.b1088.

    PMID: 19366755DERIVED

MeSH Terms

Conditions

Bursitis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Steven P Cohen, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations

US(1)