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

Phase 2

• Conditions: Finger Injuries; Hand Injuries
• Interventions: Other: Standard Mobilization Treatment; Drug: Methylprednisolone Tablet

• Registration Number: NCT05003596
• Lead Sponsor: Robert Wood Johnson Barnabas Health

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-28
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-05
• Last Update Submitted: 2021-08-05
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12
• Study Start: 2021-09-01
• Primary Completion: 2022-08-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard Mobilization Treatment	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.
Steroid Group	Methylprednisolone Tablet	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.

Primary Outcome Measures

Name	Time	Method
hand supination	12 weeks	degrees of hand supination
hand pronation	12 weeks	degrees of hand pronation
wrist ulnar deviation	12 weeks	degrees of wrist ulnar deviance
wrist radial deviation	12 weeks	degrees of radial deviance of the wrist
MCP, DIP, PIP of digits 2-5: Flexion	12 weeks	degrees of flexion for MCP, DIP, and PIP of digits 2-5
wrist flexion	12 weeks	degrees of wrist flexion
wrist extension	initial	degrees of wrist extension
MCP, DIP, PIP of digits 2-5: Extension	12 weeks	degrees of extension for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: abduction	12 weeks	degrees of abduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: adduction	12 weeks	degrees of adduction for MCP, DIP, and PIP of digits 2-5
Thumb Opposition at MCP	12 weeks	degrees of thumb opposition
Thumb extension at IP	12 weeks	degrees of thumb IP extension
Thumb flexion at IP	12 weeks	degrees of thumb IP flexion
Quick DASH Questionnaire	12 weeks	patient-reported outcome survey that evaluates functionality and patient-perceived disability

Secondary Outcome Measures

Name	Time	Method
VAS Pain Scale	12 weeks	visual analog pain scale
Complications	12 weeks	list of adverse events
Edema Measurements	12 weeks	measurements of noted edema to the study area

Trial Locations

Locations (2)

University Orthopedics Associates; 🇺🇸 Somerset, New Jersey, United States

Brielle Orthopedics; 🇺🇸 Brick, New Jersey, United States