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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

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.

Condition or disease Intervention/treatment Phase
Subacromial Bursitis Shoulder Pain Drug: Methylprednisolone, 20 mg Drug: Methylprednisolone, 40 mg Drug: Triamcinolone, 20 mg Drug: Triamcinolone, 40 mg Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone
Study Start Date : September 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Active Comparator: Methylprednisolone, 20 mg
Methylprednisolone, 20 mg, will be injected
Drug: Methylprednisolone, 40 mg
Compared with intrabursal triamcinolone
Other Name: Depo-Medrol or Solu-Medrol

Active Comparator: Methylprednisolone, 40 mg
Methylprednisolone, 40 mg, will be injected
Drug: Methylprednisolone, 20 mg
Compared with intrabursal triamcinolone
Other Name: Depo-Medrol or Solu-Medrol

Active Comparator: Triamcinolone, 20 mg
Triamcinolone, 20 mg, will be injected
Drug: Triamcinolone, 40 mg
Compared with methylprednisolone
Other Name: Kenalog

Active Comparator: Triamcinolone, 40 mg
Triamcinolone, 40 mg, will be injected
Drug: Triamcinolone, 20 mg
Compared with methylprednisolone
Other Name: Kenalog




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Safety [ Time Frame: 6 weeks ]
    Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242630


Locations
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United States, Mississippi
Keesler Medical Center
Keesler AFB, Mississippi, United States, 39534
Sponsors and Collaborators
Keesler Air Force Base Medical Center
Investigators
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Principal Investigator: Matthew B Carroll, MD Keesler Medical Center

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Responsible Party: Keesler Air Force Base Medical Center
ClinicalTrials.gov Identifier: NCT02242630     History of Changes
Other Study ID Numbers: FKE20140023H
First Posted: September 17, 2014    Key Record Dates
Results First Posted: December 14, 2016
Last Update Posted: December 14, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to release IPD to other researchers

Keywords provided by Keesler Air Force Base Medical Center:
Subacromial bursitis
Triamcinolone
Methylprednisolone
Shoulder pain

Additional relevant MeSH terms:
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Shoulder Pain
Bursitis
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents