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;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   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  
Number of Participants  
[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


No publications provided


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
Health Authority: United States: Institutional Review Board