Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
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| ClinicalTrials.gov Identifier: NCT02242630 |
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Recruitment Status :
Completed
First Posted : September 17, 2014
Results First Posted : December 14, 2016
Last Update Posted : December 14, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Subacromial Bursitis Shoulder Pain | Drug: Methylprednisolone, 20 mg Drug: Methylprednisolone, 40 mg Drug: Triamcinolone, 20 mg Drug: Triamcinolone, 40 mg | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Improvement in Function and Pain Due to Subacromial Bursitis in Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone |
| Study Start Date : | September 2014 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | March 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Methylprednisolone, 20 mg
Methylprednisolone, 20 mg, will be injected
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Drug: Methylprednisolone, 40 mg
Compared with intrabursal triamcinolone
Other Name: Depo-Medrol or Solu-Medrol |
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Active Comparator: Methylprednisolone, 40 mg
Methylprednisolone, 40 mg, will be injected
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Drug: Methylprednisolone, 20 mg
Compared with intrabursal triamcinolone
Other Name: Depo-Medrol or Solu-Medrol |
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Active Comparator: Triamcinolone, 20 mg
Triamcinolone, 20 mg, will be injected
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Drug: Triamcinolone, 40 mg
Compared with methylprednisolone
Other Name: Kenalog |
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Active Comparator: Triamcinolone, 40 mg
Triamcinolone, 40 mg, will be injected
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Drug: Triamcinolone, 20 mg
Compared with methylprednisolone
Other Name: Kenalog |
- 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)
- 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.
- Safety [ Time Frame: 6 weeks ]Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242630
| United States, Mississippi | |
| Keesler Medical Center | |
| Keesler AFB, Mississippi, United States, 39534 | |
| Principal Investigator: | Matthew B Carroll, MD | Keesler Medical Center |
| Responsible Party: | Keesler Air Force Base Medical Center |
| ClinicalTrials.gov Identifier: | NCT02242630 |
| Other Study ID Numbers: |
FKE20140023H |
| First Posted: | September 17, 2014 Key Record Dates |
| Results First Posted: | December 14, 2016 |
| Last Update Posted: | December 14, 2016 |
| Last Verified: | August 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | No plan to release IPD to other researchers |
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Subacromial bursitis Triamcinolone Methylprednisolone Shoulder pain |
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Shoulder Pain Bursitis Arthralgia Joint Diseases Musculoskeletal Diseases Pain Neurologic Manifestations Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide |
Prednisolone hemisuccinate Prednisolone phosphate Triamcinolone diacetate Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Antineoplastic Agents, Hormonal |