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Corticosteroid Injection for Common Upper Extremity Problems

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438672
First received: February 20, 2007
Last updated: April 25, 2012
Last verified: April 2012
Results First Received: March 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Lateral Elbow Pain
Interventions: Drug: Placebo Injection
Drug: Steroid (dexamethasone) Injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dexamethasone Cohort Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
Placebo (Lidocaine Only) Cohort Single injection of 2 mL 1% lidocaine

Participant Flow:   Overall Study
    Dexamethasone Cohort   Placebo (Lidocaine Only) Cohort
STARTED   31   33 
COMPLETED   24   24 
NOT COMPLETED   7   9 
Lost to Follow-up                7                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Dexamethasone Cohort Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
Placebo (Lidocaine Only) Cohort Single injection of 2 mL 1% lidocaine
Total Total of all reporting groups

Baseline Measures
   Dexamethasone Cohort   Placebo (Lidocaine Only) Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   33   64 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   31   31   62 
>=65 years   0   2   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (8)   49  (10)   49  (9) 
Gender 
[Units: Participants]
     
Female   19   18   37 
Male   12   15   27 
Region of Enrollment 
[Units: Participants]
     
United States   31   33   64 


  Outcome Measures
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1.  Primary:   Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire   [ Time Frame: 6 months ]

2.  Primary:   Visual Analog Scale for Pain   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. David Ring
Organization: Massachusetts General Hospital
phone: 617-724-3953
e-mail: dring@partners.org



Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438672     History of Changes
Other Study ID Numbers: 2003-P-000322
Study First Received: February 20, 2007
Results First Received: March 22, 2012
Last Updated: April 25, 2012