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Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis

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ClinicalTrials.gov Identifier: NCT02242630
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Keesler Air Force Base Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Subacromial Bursitis
Shoulder Pain
Interventions Drug: Methylprednisolone, 20 mg
Drug: Methylprednisolone, 40 mg
Drug: Triamcinolone, 20 mg
Drug: Triamcinolone, 40 mg
Enrollment 61
Recruitment Details Subjects for this study were recruited from the internal medicine (IM) clinic or IM subspecialties clinic from our academic community hospital between September 2014 and December 2015. Subjects had to satisfy the inclusion criteria and have none of the exclusion criteria.
Pre-assignment Details There was no wash out, run-in, or transitions in this trial.
Arm/Group Title Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg
Hide Arm/Group Description

Methylprednisolone, 20 mg, will be injected

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Methylprednisolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 20 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Period Title: Overall Study
Started 15 15 15 16
Completed 15 15 15 16
Not Completed 0 0 0 0
Arm/Group Title Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg Total
Hide Arm/Group Description

Methylprednisolone, 20 mg, will be injected

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Methylprednisolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 20 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 16 61
Hide Baseline Analysis Population Description
Fifteen subjects were enrolled in each arm except for the TAC40 arm which had 16. The average age of the cohort was 67.1 ± 10.8 years old.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 61 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  53.3%
8
  53.3%
7
  46.7%
8
  50.0%
31
  50.8%
>=65 years
7
  46.7%
7
  46.7%
8
  53.3%
8
  50.0%
30
  49.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 16 participants 61 participants
63.0  (10.9) 69.3  (10.0) 66.9  (12.3) 69.0  (9.5) 67.1  (10.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 61 participants
Female
10
  66.7%
6
  40.0%
6
  40.0%
7
  43.8%
29
  47.5%
Male
5
  33.3%
9
  60.0%
9
  60.0%
9
  56.3%
32
  52.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 15 participants 16 participants 61 participants
15 15 15 16 61
1.Primary Outcome
Title Change in Shoulder Function, as Measured by the QuickDASH ®
Hide Description The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg
Hide Arm/Group Description:

Methylprednisolone, 20 mg, will be injected

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Methylprednisolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 20 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Overall Number of Participants Analyzed 15 15 15 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
19.2
(7.1 to 31.4)
21.3
(11.3 to 31.4)
19.1
(11.8 to 26.4)
24.7
(16.4 to 33.1)
2.Secondary Outcome
Title Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
Hide Description Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg
Hide Arm/Group Description:

Methylprednisolone, 20 mg, will be injected

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Methylprednisolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 20 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Overall Number of Participants Analyzed 15 15 15 16
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.0
(0.1 to 1.9)
1.8
(0.1 to 3.5)
1.9
(0.6 to 3.2)
1.8
(0.4 to 3.2)
3.Other Pre-specified Outcome
Title Safety
Hide Description Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.
Time Frame 6 weeks
Outcome Measure Data Not Reported
Time Frame Data regarding adverse events were collected for the 6 weeks that subjects were followed in this trial, with subjects queried about adverse events at the time of injection, 3 days after injection, 3 weeks, and 6 weeks after injection.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg
Hide Arm/Group Description

Methylprednisolone, 20 mg, will be injected

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Methylprednisolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 20 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 40 mg: Compared with methylprednisolone

Triamcinolone, 40 mg, will be injected

Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone

Triamcinolone, 20 mg: Compared with methylprednisolone

All-Cause Mortality
Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Methylprednisolone, 20 mg Methylprednisolone, 40 mg Triamcinolone, 20 mg Triamcinolone, 40 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      1/15 (6.67%)      0/15 (0.00%)      1/16 (6.25%)    
Endocrine disorders         
Elevated blood glucose * [1]  1/15 (6.67%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0 1/16 (6.25%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Increase in blood glucose as measured by participant which would be considered by the participant as beyond their normal range
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Matthew B. Carroll
Organization: Keesler Medical Center
Phone: 228-376-3629
Responsible Party: Keesler Air Force Base Medical Center
ClinicalTrials.gov Identifier: NCT02242630     History of Changes
Other Study ID Numbers: FKE20140023H
First Submitted: September 14, 2014
First Posted: September 17, 2014
Results First Submitted: August 29, 2016
Results First Posted: December 14, 2016
Last Update Posted: December 14, 2016