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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

Tracking Information
First Submitted Date  ICMJE September 14, 2014
First Posted Date  ICMJE September 17, 2014
Results First Submitted Date  ICMJE August 29, 2016
Results First Posted Date  ICMJE December 14, 2016
Last Update Posted Date December 14, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2016)
Change in Shoulder Function, as Measured by the QuickDASH ® [ Time Frame: 6 weeks ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Improvement in shoulder function, as measured by the QuickDASH ® [ Time Frame: 6 weeks ]
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)
Change History Complete list of historical versions of study NCT02242630 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2016)
Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale [ Time Frame: 6 weeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
Improvement in subject reported shoulder pain as measured by the Visual Analogue Scale [ Time Frame: 6 weeks ]
Improvement in shoulder pain reported by the subject after injection at 6 weeks. The patient will indicate from 0 (no pain) to 10 (maximal pain) changes in shoulder pain after injection. A 2 point change is expected.
Current Other Pre-specified Outcome Measures
 (submitted: September 15, 2014)
Safety [ Time Frame: 6 weeks ]
Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
Official Title  ICMJE Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Subacromial Bursitis
  • Shoulder Pain
Intervention  ICMJE
  • Drug: Methylprednisolone, 20 mg
    Compared with intrabursal triamcinolone
    Other Name: Depo-Medrol or Solu-Medrol
  • Drug: Methylprednisolone, 40 mg
    Compared with intrabursal triamcinolone
    Other Name: Depo-Medrol or Solu-Medrol
  • Drug: Triamcinolone, 20 mg
    Compared with methylprednisolone
    Other Name: Kenalog
  • Drug: Triamcinolone, 40 mg
    Compared with methylprednisolone
    Other Name: Kenalog
Study Arms  ICMJE
  • Active Comparator: Methylprednisolone, 20 mg
    Methylprednisolone, 20 mg, will be injected
    Intervention: Drug: Methylprednisolone, 40 mg
  • Active Comparator: Methylprednisolone, 40 mg
    Methylprednisolone, 40 mg, will be injected
    Intervention: Drug: Methylprednisolone, 20 mg
  • Active Comparator: Triamcinolone, 20 mg
    Triamcinolone, 20 mg, will be injected
    Intervention: Drug: Triamcinolone, 40 mg
  • Active Comparator: Triamcinolone, 40 mg
    Triamcinolone, 40 mg, will be injected
    Intervention: Drug: Triamcinolone, 20 mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2016)
61
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
300
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02242630
Other Study ID Numbers  ICMJE FKE20140023H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to release IPD to other researchers
Responsible Party Keesler Air Force Base Medical Center
Study Sponsor  ICMJE Keesler Air Force Base Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew B Carroll, MD Keesler Medical Center
PRS Account Keesler Air Force Base Medical Center
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP