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

NCT02242630 | Completed Results

• 1 other identifier: FKE20140023H
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Bursitis; Shoulder Pain

Keywords

Subacromial bursitis; Triamcinolone; Methylprednisolone; Shoulder pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale

  6 weeks

Other Outcomes (1)

• Safety

  6 weeks

Study Arms (4)

Methylprednisolone, 20 mg

ACTIVE COMPARATOR

Methylprednisolone, 20 mg, will be injected

Drug: Methylprednisolone, 40 mg

Methylprednisolone, 40 mg

ACTIVE COMPARATOR

Methylprednisolone, 40 mg, will be injected

Drug: Methylprednisolone, 20 mg

Triamcinolone, 20 mg

ACTIVE COMPARATOR

Triamcinolone, 20 mg, will be injected

Drug: Triamcinolone, 40 mg

Triamcinolone, 40 mg

ACTIVE COMPARATOR

Triamcinolone, 40 mg, will be injected

Drug: Triamcinolone, 20 mg

Interventions

Methylprednisolone, 20 mg DRUG

Compared with intrabursal triamcinolone

Also known as: Depo-Medrol or Solu-Medrol

Methylprednisolone, 40 mg

Methylprednisolone, 40 mg DRUG

Compared with intrabursal triamcinolone

Also known as: Depo-Medrol or Solu-Medrol

Methylprednisolone, 20 mg

Triamcinolone, 20 mg DRUG

Compared with methylprednisolone

Also known as: Kenalog

Triamcinolone, 40 mg

Triamcinolone, 40 mg DRUG

Compared with methylprednisolone

Also known as: Kenalog

Triamcinolone, 20 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keesler Air Force Base Medical Center: lead

Study Sites (1)

Keesler Medical Center

Keesler Air Force Base, Mississippi, 39534, United States

Location

Related Publications (1)

• 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.

  PMID: 28609319 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Interventions

Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Triamcinolone; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Matthew B. Carroll
• Organization: Keesler Medical Center

matthew.carroll.1@us.af.mil

228-376-3629

Study Officials

• Matthew B Carroll, MD

  Keesler Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 14, 2016
• Results First Posted: December 14, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)