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Corticosteroid Injection for Common Upper Extremity Problems

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ClinicalTrials.gov Identifier: NCT00438672
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : May 28, 2012
Last Update Posted : May 28, 2012
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Lateral Elbow Pain
Interventions Drug: Placebo Injection
Drug: Steroid (dexamethasone) Injection
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexamethasone Cohort Placebo (Lidocaine Only) Cohort
Hide Arm/Group Description Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine Single injection of 2 mL 1% lidocaine
Period Title: Overall Study
Started 31 33
Completed 24 24
Not Completed 7 9
Reason Not Completed
Lost to Follow-up             7             9
Arm/Group Title Dexamethasone Cohort Placebo (Lidocaine Only) Cohort Total
Hide Arm/Group Description Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine Single injection of 2 mL 1% lidocaine Total of all reporting groups
Overall Number of Baseline Participants 31 33 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
 100.0%
31
  93.9%
62
  96.9%
>=65 years
0
   0.0%
2
   6.1%
2
   3.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 33 participants 64 participants
48  (8) 49  (10) 49  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Female
19
  61.3%
18
  54.5%
37
  57.8%
Male
12
  38.7%
15
  45.5%
27
  42.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 33 participants 64 participants
31 33 64
1.Primary Outcome
Title Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Cohort Placebo (Lidocaine Only) Cohort
Hide Arm/Group Description:
Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
Single injection of 2 mL 1% lidocaine
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
18  (20) 13  (19)
2.Primary Outcome
Title Visual Analog Scale for Pain
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Cohort Placebo (Lidocaine Only) Cohort
Hide Arm/Group Description:
Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
Single injection of 2 mL 1% lidocaine
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (2.9) 1.7  (2.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone Cohort Placebo (Lidocaine Only) Cohort
Hide Arm/Group Description Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine Single injection of 2 mL 1% lidocaine
All-Cause Mortality
Dexamethasone Cohort Placebo (Lidocaine Only) Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone Cohort Placebo (Lidocaine Only) Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexamethasone Cohort Placebo (Lidocaine Only) Cohort
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/33 (0.00%) 
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
Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438672     History of Changes
Other Study ID Numbers: 2003-P-000322
First Submitted: February 20, 2007
First Posted: February 22, 2007
Results First Submitted: March 22, 2012
Results First Posted: May 28, 2012
Last Update Posted: May 28, 2012