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

NCT ID: NCT02242630

Last Updated: 2016-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Subacromial Bursitis Shoulder Pain

Keywords

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Subacromial bursitis Triamcinolone Methylprednisolone Shoulder pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Methylprednisolone, 20 mg

Methylprednisolone, 20 mg, will be injected

Group Type ACTIVE_COMPARATOR

Methylprednisolone, 40 mg

Intervention Type DRUG

Compared with intrabursal triamcinolone

Methylprednisolone, 40 mg

Methylprednisolone, 40 mg, will be injected

Group Type ACTIVE_COMPARATOR

Methylprednisolone, 20 mg

Intervention Type DRUG

Compared with intrabursal triamcinolone

Triamcinolone, 20 mg

Triamcinolone, 20 mg, will be injected

Group Type ACTIVE_COMPARATOR

Triamcinolone, 40 mg

Intervention Type DRUG

Compared with methylprednisolone

Triamcinolone, 40 mg

Triamcinolone, 40 mg, will be injected

Group Type ACTIVE_COMPARATOR

Triamcinolone, 20 mg

Intervention Type DRUG

Compared with methylprednisolone

Interventions

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Methylprednisolone, 20 mg

Compared with intrabursal triamcinolone

Intervention Type DRUG

Methylprednisolone, 40 mg

Compared with intrabursal triamcinolone

Intervention Type DRUG

Triamcinolone, 20 mg

Compared with methylprednisolone

Intervention Type DRUG

Triamcinolone, 40 mg

Compared with methylprednisolone

Intervention Type DRUG

Other Intervention Names

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Depo-Medrol or Solu-Medrol Depo-Medrol or Solu-Medrol Kenalog Kenalog

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keesler Air Force Base Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew B Carroll, MD

Role: PRINCIPAL_INVESTIGATOR

Keesler Medical Center

Locations

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Keesler Medical Center

Keesler Air Force Base, Mississippi, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28609319 (View on PubMed)

Other Identifiers

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FKE20140023H

Identifier Type: -

Identifier Source: org_study_id