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Completed

NCT Number: NCT02242630

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

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.

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Key information

Conditions

Subacromial Bursitis Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keesler Medical Center

Keesler Air Force Base, Mississippi, 39534, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone, 20 mg

Drug

Compared with intrabursal triamcinolone

Other names: Depo-Medrol or Solu-Medrol

Methylprednisolone, 40 mg

Drug

Compared with intrabursal triamcinolone

Other names: Depo-Medrol or Solu-Medrol

Triamcinolone, 20 mg

Drug

Compared with methylprednisolone

Other names: Kenalog

Triamcinolone, 40 mg

Drug

Compared with methylprednisolone

Other names: Kenalog

Primary outcomes

  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 outcomes

  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 outcomes

  1. Safety

    Time frame: 6 weeks

    Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.

Sponsors and collaborators

Lead sponsor

Keesler Air Force Base Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2014
Registry last updated
Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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