NCT05003596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

July 28, 2021

Last Update Submit

August 5, 2021

Conditions

Hand InjuriesFinger Injuries

Outcome Measures

Primary Outcomes (54)

  • wrist flexion

    degrees of wrist flexion

    initial

  • wrist flexion

    degrees of wrist flexion

    3 weeks

  • wrist flexion

    degrees of wrist flexion

    6 weeks

  • wrist flexion

    degrees of wrist flexion

    12 weeks

  • wrist extension

    degrees of wrist extension

    12 weeks

  • wrist extension

    degrees of wrist extension

    6 weeks

  • wrist extension

    degrees of wrist extension

    3 weeks

  • wrist extension

    degrees of wrist extension

    initial

  • hand supination

    degrees of hand supination

    initial

  • hand supination

    degrees of hand supination

    3 weeks

  • hand supination

    degrees of hand supination

    6 weeks

  • hand supination

    degrees of hand supination

    12 weeks

  • hand pronation

    degrees of hand pronation

    initial

  • hand pronation

    degrees of hand pronation

    3 weeks

  • hand pronation

    degrees of hand pronation

    6 weeks

  • hand pronation

    degrees of hand pronation

    12 weeks

  • wrist ulnar deviation

    degrees of wrist ulnar deviance

    initial

  • wrist ulnar deviation

    degrees of wrist ulnar deviance

    3 weeks

  • wrist ulnar deviation

    degrees of wrist ulnar deviance

    6 weeks

  • wrist ulnar deviation

    degrees of wrist ulnar deviance

    12 weeks

  • wrist radial deviation

    degrees of radial deviance of the wrist

    initial

  • wrist radial deviation

    degrees of radial deviance of the wrist

    3 weeks

  • wrist radial deviation

    degrees of radial deviance of the wrist

    6 weeks

  • wrist radial deviation

    degrees of radial deviance of the wrist

    12 weeks

  • MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    initial

  • MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    3 weeks

  • MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    6 weeks

  • MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    12 weeks

  • MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    initial

  • MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    3 weeks

  • MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    6 weeks

  • MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    12 weeks

  • MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    initial

  • MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    3 weeks

  • MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    6 weeks

  • MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    12 weeks

  • MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    initial

  • MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    3 weeks

  • MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    6 weeks

  • MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    12 weeks

  • Thumb Opposition at MCP

    degrees of thumb opposition

    initial

  • Thumb Opposition at MCP

    degrees of thumb opposition

    3 weeks

  • Thumb Opposition at MCP

    degrees of thumb opposition

    6 weeks

  • Thumb Opposition at MCP

    degrees of thumb opposition

    12 weeks

  • Thumb extension at IP

    degrees of thumb IP extension

    initial

  • Thumb extension at IP

    degrees of thumb IP extension

    3 weeks

  • Thumb extension at IP

    degrees of thumb IP extension

    6 weeks

  • Thumb extension at IP

    degrees of thumb IP extension

    12 weeks

  • Thumb flexion at IP

    degrees of thumb IP flexion

    initial

  • Thumb flexion at IP

    degrees of thumb IP flexion

    3 weeks

  • Thumb flexion at IP

    degrees of thumb IP flexion

    6 weeks

  • Thumb flexion at IP

    degrees of thumb IP flexion

    12 weeks

  • Quick DASH Questionnaire

    patient-reported outcome survey that evaluates functionality and patient-perceived disability

    6 weeks

  • Quick DASH Questionnaire

    patient-reported outcome survey that evaluates functionality and patient-perceived disability

    12 weeks

Secondary Outcomes (9)

  • VAS Pain Scale

    3 weeks

  • VAS Pain Scale

    6 weeks

  • VAS Pain Scale

    12 weeks

  • Complications

    3 weeks

  • Complications

    6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Steroid Group

EXPERIMENTAL

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.

Drug: Methylprednisolone Tablet

Control Group

ACTIVE COMPARATOR

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.

Other: Standard Mobilization Treatment

Interventions

Methylprednisolone TabletDRUG

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

Also known as: Solu-Medrol Dosepak
Steroid Group
Standard Mobilization TreatmentOTHER

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

Also known as: buddy taping, finger splint, tylenol, narcotics
Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brielle Orthopedics

Brick, New Jersey, 08724, United States

Location

University Orthopedics Associates

Somerset, New Jersey, 08873, United States

Location

Related Publications (4)

  • Rytter S, Stilling M, Munk S, Hansen TB. Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):284-290. doi: 10.1007/s00167-014-3501-8. Epub 2015 Jan 7.

    PMID: 25564196BACKGROUND

  • Yang Z, Lim PPH, Teo SH, Chen H, Qiu H, Pua YH. Association of wrist and forearm range of motion measures with self-reported functional scores amongst patients with distal radius fractures: a longitudinal study. BMC Musculoskelet Disord. 2018 May 11;19(1):142. doi: 10.1186/s12891-018-2065-z.

    PMID: 29747624BACKGROUND

  • Troullos ES, Hargreaves KM, Butler DP, Dionne RA. Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus. J Oral Maxillofac Surg. 1990 Sep;48(9):945-52. doi: 10.1016/0278-2391(90)90007-o.

    PMID: 2395047BACKGROUND

  • Boursinos LA, Karachalios T, Poultsides L, Malizos KN. Do steroids, conventional non-steroidal anti-inflammatory drugs and selective Cox-2 inhibitors adversely affect fracture healing? J Musculoskelet Neuronal Interact. 2009 Jan-Mar;9(1):44-52.

    PMID: 19240368BACKGROUND

Related Links

MeSH Terms

Conditions

Hand InjuriesFinger Injuries

Interventions

MethylprednisoloneAcetaminophenNarcotics

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Brian Katt, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bobby Varghese, MD

CONTACT

8324657112bv209@rwjms.rutgers.edu

Anna Green, MD

CONTACT

annagreen7@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
data without intervention identification will be analyzed by outcome assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 12, 2021

Study Start

September 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2023

Last Updated

August 12, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)