NCT05003596

Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Robert Wood Johnson Barnabas Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Steroids are often prescribed for their anti-inflammatory effects in patients with musculoskeletal injuries. Studies have shown that steroids may reduce pain and swelling, but their effects on range of motion and functional outcomes have not been illustrated. With this study, we aim to evaluate the effect of steroids on range of motion and functional outcomes in non-operatively managed musculoskeletal injuries of the hand.

Detailed description

Previous studies have investigated the effect of steroids on bone healing, edema reduction and postoperative pain. However, there seems to be a lack of literature on whether the use of steroids for their anti-inflammatory effects actually lead to improved range of motion and functional capacity. If the data shows that steroids do indeed help patients achieve increased functional outcomes, they may be used with higher confidence in their beneficial contribution to patient treatment and quality of life. If, however, the data show that steroids do not confer a significant benefit, they can be disregarded as they will avoid the risks associated with steroid use. We aim to investigate if the use of methylprednisolone will result in significantly improved ranges of motion and self-reported function compared to a control group at each measurement time point.

Conditions

• Hand Injuries
• Finger Injuries

Interventions

Type	Name	Description
DRUG	Methylprednisolone Tablet	Subjects will take a quantity 21 4mg tablets over a 6 week taper.
OTHER	Standard Mobilization Treatment	standard treatment of hand injuries with focus on mobilization. No anti-inflammatory medications. Pain management via Tylenol or narcotics if deemed necessary.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-08-01
• Completion: 2023-09-01
• First posted: 2021-08-12
• Last updated: 2021-08-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study