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

Robert Wood Johnson Barnabas Health

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Finger Injuries; Hand Injuries

Treatments: Drug: Methylprednisolone Tablet; Other: Standard Mobilization Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05003596

Pro2021000732

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with soft tissue injuries and stable fractures from the metacarpophalangeal joint to the distal phalanx

Exclusion criteria

• Patients at increased risk of serious side effects of steroid administration.
• Patients unable to provide consent
• Unable to swallow oral medications
• Pregnant women
• ages less than 18 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Steroid Group

Experimental group

Description:

Patients receive 21 tablets of 4 mg methylprednisolone to be taken by mouth over a 6 week taper. Patients will be advised to not take other anti-inflammatory medications like NSAIDs.

Treatment:

Drug: Methylprednisolone Tablet

Control Group

Active Comparator group

Description:

Patients will recieve standard treatment that focuses on mobilization and stabilization using common techniques like buddy taping and splinting. Pain control will be managed using non-NSAID medications like Tylenol or opioid narcotics when deemed medically necessary.

Treatment:

Other: Standard Mobilization Treatment