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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05003596
Enrollment
60
Registered
2021-08-12
Start date
2021-09-01
Completion date
2023-09-01
Last updated
2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Finger Injuries, Hand Injuries

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.

Interventions

Subjects will take a quantity 21 4mg tablets over a 6 week taper.

OTHERStandard Mobilization Treatment

standard treatment of hand injuries with focus on mobilization. No anti-inflammatory medications. Pain management via Tylenol or narcotics if deemed necessary.

Sponsors

Brielle Orthopedics
CollaboratorUNKNOWN
University Orthopedics Associates
CollaboratorUNKNOWN
Robert Wood Johnson Barnabas Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

data without intervention identification will be analyzed by outcome assessor

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quick DASH Questionnaire6 weekspatient-reported outcome survey that evaluates functionality and patient-perceived disability
Thumb Opposition at MCPinitialdegrees of thumb opposition
Thumb extension at IPinitialdegrees of thumb IP extension
Thumb flexion at IPinitialdegrees of thumb IP flexion
wrist flexioninitialdegrees of wrist flexion
wrist extension12 weeksdegrees of wrist extension
hand supinationinitialdegrees of hand supination
hand pronationinitialdegrees of hand pronation
wrist ulnar deviationinitialdegrees of wrist ulnar deviance
wrist radial deviationinitialdegrees of radial deviance of the wrist
MCP, DIP, PIP of digits 2-5: Flexioninitialdegrees of flexion for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Extensioninitialdegrees of extension for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: abductioninitialdegrees of abduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: adductioninitialdegrees of adduction for MCP, DIP, and PIP of digits 2-5

Secondary

MeasureTime frameDescription
Complications3 weekslist of adverse events
Edema Measurements3 weeksmeasurements of noted edema to the study area
VAS Pain Scale3 weeksvisual analog pain scale

Countries

United States

Contacts

Primary ContactBobby Varghese, MD
bv209@rwjms.rutgers.edu8324657112
Backup ContactAnna Green, MD
annagreen7@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026