NCT00438672

Brief Summary

The purpose of the study is to compare the effectiveness of a steroid injection to a placebo (inactive substance) in the treatment of lateral elbow pain, deQuervain's tendonitis, or base of the thumb carpometacarpal (CMC) arthritis. We are also trying to identify which personality factors and mindsets influence perceptions of elbow, wrist and hand pain. We hope to enroll 213 subjects in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

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

April 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 28, 2012

Completed
Last Updated

May 28, 2012

Status Verified

April 1, 2012

Enrollment Period

7.1 years

First QC Date

February 20, 2007

Results QC Date

March 22, 2012

Last Update Submit

April 25, 2012

Conditions

Lateral Elbow Pain

Keywords

lateral elbow paintennis elbowpainpsychology

Outcome Measures

Primary Outcomes (2)

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

    The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.

    6 months

  • Visual Analog Scale for Pain

    Pain is measured on a 10 cm long line that starts at 0 on the left and ends with 10 on the right. A score of 0 represents no pain at all, and a score of 10 represents the worst pain ever. The individual score is measured using a measuring rod, measuring the distance from the left border in centimeters.

    6 months

Study Arms (3)

Dequervains

ACTIVE COMPARATOR

The de Quervain's injection study was terminated due to difficulty with enrollment. A large percentage of patients declined, and DeQuervain's is also fairly uncommon. Therefore, the trial wasn't feasible for this diagnosis.

Drug: Placebo InjectionDrug: Steroid (dexamethasone) Injection

Lateral Epicondylitis

ACTIVE COMPARATOR
Drug: Placebo InjectionDrug: Steroid (dexamethasone) Injection

CMC Arthritis

ACTIVE COMPARATOR

The CMC Arthritis injection study was terminated due to difficulty with enrollment. A large percentage of patients declined, and it was decided that the trial wasn't feasible for this diagnosis.

Drug: Placebo InjectionDrug: Steroid (dexamethasone) Injection

Interventions

Placebo InjectionDRUG

Injection without steroid

CMC ArthritisDequervainsLateral Epicondylitis
Steroid (dexamethasone) InjectionDRUG

Injection with steroid (dexamethasone)

CMC ArthritisDequervainsLateral Epicondylitis

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 64 years
  • onset of pain within the past 6 months
  • willing to try a steroid injection in the elbow

You may not qualify if:

  • systemic inflammatory diseases (e.g., rheumatoid arthritis)
  • pregnancy
  • prior steroid injection, iontophoresis treatments with corticosteroids, or surgery for their pain
  • history of adverse reaction to lidocaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Tennis ElbowPain

Interventions

SteroidsDexamethasoneInjections

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroids, FluorinatedDrug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Dr. David Ring
Organization
Massachusetts General Hospital
dring@partners.org
617-724-3953

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Hand Service

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

April 1, 2003

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 28, 2012

Results First Posted

May 28, 2012

Record last verified: 2012-04

Locations

US(1)