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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02242630
• Other study ID #: FKE20140023H
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2014
• Last updated: January 1, 2016
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: January 2016
• Source: Keesler Air Force Base Medical Center
• Contact: Matthew B Carroll, MD
• Phone: 228-376-3629
• Email: matthew.carroll.1[@]us.af.mil
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis
• Shoulder Pain
• Subacromial Bursitis

Intervention

Drug:
• Methylprednisolone, 20 mg
Compared with intrabursal triamcinolone
• Methylprednisolone, 40 mg
Compared with intrabursal triamcinolone
• Triamcinolone, 20 mg
Compared with methylprednisolone
• Triamcinolone, 40 mg
Compared with methylprednisolone

Locations

Country	Name	City	State
United States	Keesler Medical Center	Keesler AFB	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Keesler Air Force Base Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.	6 weeks	Yes
Primary	Improvement 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)	6 weeks	No
Secondary	Improvement in subject reported shoulder pain as measured by the Visual Analogue Scale	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.	6 weeks	No