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

Primary Purpose

Subacromial Bursitis, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone, 20 mg
Methylprednisolone, 40 mg
Triamcinolone, 20 mg
Triamcinolone, 40 mg
Sponsored by
Keesler Air Force Base Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Bursitis focused on measuring Subacromial bursitis, Triamcinolone, Methylprednisolone, Shoulder pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • History and physical examination consistent with shoulder pain and subacromial bursitis
  • At least 2 weeks of shoulder pain and subacromial bursitis

Exclusion Criteria:

  • Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone
  • History or examination suspicious for a humeral head fracture
  • History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side
  • History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint
  • Any shoulder surgery involving the affected arm within the last 6 months

Sites / Locations

  • Keesler Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Methylprednisolone, 20 mg

Methylprednisolone, 40 mg

Triamcinolone, 20 mg

Triamcinolone, 40 mg

Arm Description

Methylprednisolone, 20 mg, will be injected

Methylprednisolone, 40 mg, will be injected

Triamcinolone, 20 mg, will be injected

Triamcinolone, 40 mg, will be injected

Outcomes

Primary Outcome Measures

Change in Shoulder Function, as Measured by the QuickDASH ®
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)

Secondary Outcome Measures

Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
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.

Full Information

First Posted
September 14, 2014
Last Updated
October 22, 2016
Sponsor
Keesler Air Force Base Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02242630
Brief Title
Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
Official Title
Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keesler Air Force Base Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.
Detailed Description
Background: Subacromial bursitis is a common site for patients to report shoulder pain. In some patients it is refractory to conservative therapies such as physical therapy, acetaminophen, or NSAIDs. Subacromial injection of a corticosteroid can be used to improve shoulder pain in subacromial bursitis, however, there are few well done clinical trials guiding which type of corticosteroid and the dose that would be maximally effective and with the least amount of side effects. Methods: Our hypothesis is that both Methylprednisolone and Triamcinolone are equipotent but that 20 mg provides less relief that 40 mg injected. Subjects will be enrolled in this trial which lasts 6 weeks. Subjects will be randomized to 40 mg of methylprednisolone, 20 mg of methylprednisolone, 40 mg of triamcinolone, or 20 mg of triamcinolone. No placebo will be used as prior studies suggest that placebo with lidocaine is inferior to corticosteroid injection. Outcomes: Primary outcome with be the improvement in a functional measure of the shoulder, the QuickDASH ®, at 6 weeks. Secondary outcomes will be improvement in reported pain (visual analogue scale) at 6 weeks and adverse events at all time points. Data will be collected in person at the time of injection and then by phone at day 3, day 21 (3 weeks), and day 42 (6 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Bursitis, Shoulder Pain
Keywords
Subacromial bursitis, Triamcinolone, Methylprednisolone, Shoulder pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisolone, 20 mg
Arm Type
Active Comparator
Arm Description
Methylprednisolone, 20 mg, will be injected
Arm Title
Methylprednisolone, 40 mg
Arm Type
Active Comparator
Arm Description
Methylprednisolone, 40 mg, will be injected
Arm Title
Triamcinolone, 20 mg
Arm Type
Active Comparator
Arm Description
Triamcinolone, 20 mg, will be injected
Arm Title
Triamcinolone, 40 mg
Arm Type
Active Comparator
Arm Description
Triamcinolone, 40 mg, will be injected
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone, 20 mg
Other Intervention Name(s)
Depo-Medrol or Solu-Medrol
Intervention Description
Compared with intrabursal triamcinolone
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone, 40 mg
Other Intervention Name(s)
Depo-Medrol or Solu-Medrol
Intervention Description
Compared with intrabursal triamcinolone
Intervention Type
Drug
Intervention Name(s)
Triamcinolone, 20 mg
Other Intervention Name(s)
Kenalog
Intervention Description
Compared with methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Triamcinolone, 40 mg
Other Intervention Name(s)
Kenalog
Intervention Description
Compared with methylprednisolone
Primary Outcome Measure Information:
Title
Change in Shoulder Function, as Measured by the QuickDASH ®
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
Secondary Outcome Measure Information:
Title
Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale
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
Other Pre-specified Outcome Measures:
Title
Safety
Description
Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older History and physical examination consistent with shoulder pain and subacromial bursitis At least 2 weeks of shoulder pain and subacromial bursitis Exclusion Criteria: Known allergies to Lidocaine, Marcaine, Methylprednisolone, and/or Triamcinolone History or examination suspicious for a humeral head fracture History or examination consistent with adhesive capsulitis (normal X-Ray of the shoulder but with less than 100 degrees of active or passive elevation of the arm, when raising the arm above the head to a maximum with passive external rotation being 50 degrees less than the unaffected side History or examination consistent with acute synovitis of the glenohumeral or acromioclavicular joint Any shoulder surgery involving the affected arm within the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew B Carroll, MD
Organizational Affiliation
Keesler Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keesler Medical Center
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to release IPD to other researchers
Citations:
PubMed Identifier
28609319
Citation
Carroll MB, Motley SA, Smith B, Ramsey BC, Baggett AS. Comparing Corticosteroid Preparation and Dose in the Improvement of Shoulder Function and Pain: A Randomized, Single-Blind Pilot Study. Am J Phys Med Rehabil. 2018 Jun;97(6):450-455. doi: 10.1097/PHM.0000000000000758.
Results Reference
derived

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

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