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

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Subacromial Bursitis
• Intervention / Treatment: Drug: Methylprednisolone, 40 mg; Drug: Methylprednisolone, 20 mg; Drug: Triamcinolone, 40 mg; Drug: Triamcinolone, 20 mg

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: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Keesler AFB, Mississippi, United States, 39534
      • Keesler Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methylprednisolone, 20 mg; Methylprednisolone, 20 mg, will be injected	Drug: Methylprednisolone, 40 mg; Compared with intrabursal triamcinolone; Other Names: 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 Names: Depo-Medrol or Solu-Medrol
Active Comparator: Triamcinolone, 20 mg; Triamcinolone, 20 mg, will be injected	Drug: Triamcinolone, 40 mg; Compared with methylprednisolone; Other Names: Kenalog
Active Comparator: Triamcinolone, 40 mg; Triamcinolone, 40 mg, will be injected	Drug: Triamcinolone, 20 mg; Compared with methylprednisolone; Other Names: Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.	6 weeks

Collaborators and Investigators

• Sponsor: Keesler Air Force Base Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 14, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Estimate): December 14, 2016
• Last Update Submitted That Met QC Criteria: October 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Triamcinolone; Methylprednisolone; Shoulder pain; Subacromial bursitis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Bursitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: FKE20140023H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to release IPD to other researchers