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

August 5, 2021 updated by: Bobby Varghese, Robert Wood Johnson Barnabas Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Brielle Orthopedics
        • Contact:
          • Michelle Bettino
        • Principal Investigator:
          • Brian Katt, MD
      • Somerset, New Jersey, United States, 08873
        • University Orthopedics Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Steroid Group
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
Subjects will take a quantity 21 4mg tablets over a 6 week taper.
Other Names:
  • Solu-Medrol Dosepak
Active Comparator: Control Group
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
standard treatment of hand injuries with focus on mobilization. No anti-inflammatory medications. Pain management via Tylenol or narcotics if deemed necessary.
Other Names:
  • tylenol
  • buddy taping
  • finger splint
  • narcotics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
wrist flexion
Time Frame: initial
degrees of wrist flexion
initial
wrist flexion
Time Frame: 3 weeks
degrees of wrist flexion
3 weeks
wrist flexion
Time Frame: 6 weeks
degrees of wrist flexion
6 weeks
wrist flexion
Time Frame: 12 weeks
degrees of wrist flexion
12 weeks
wrist extension
Time Frame: 12 weeks
degrees of wrist extension
12 weeks
wrist extension
Time Frame: 6 weeks
degrees of wrist extension
6 weeks
wrist extension
Time Frame: 3 weeks
degrees of wrist extension
3 weeks
wrist extension
Time Frame: initial
degrees of wrist extension
initial
hand supination
Time Frame: initial
degrees of hand supination
initial
hand supination
Time Frame: 3 weeks
degrees of hand supination
3 weeks
hand supination
Time Frame: 6 weeks
degrees of hand supination
6 weeks
hand supination
Time Frame: 12 weeks
degrees of hand supination
12 weeks
hand pronation
Time Frame: initial
degrees of hand pronation
initial
hand pronation
Time Frame: 3 weeks
degrees of hand pronation
3 weeks
hand pronation
Time Frame: 6 weeks
degrees of hand pronation
6 weeks
hand pronation
Time Frame: 12 weeks
degrees of hand pronation
12 weeks
wrist ulnar deviation
Time Frame: initial
degrees of wrist ulnar deviance
initial
wrist ulnar deviation
Time Frame: 3 weeks
degrees of wrist ulnar deviance
3 weeks
wrist ulnar deviation
Time Frame: 6 weeks
degrees of wrist ulnar deviance
6 weeks
wrist ulnar deviation
Time Frame: 12 weeks
degrees of wrist ulnar deviance
12 weeks
wrist radial deviation
Time Frame: initial
degrees of radial deviance of the wrist
initial
wrist radial deviation
Time Frame: 3 weeks
degrees of radial deviance of the wrist
3 weeks
wrist radial deviation
Time Frame: 6 weeks
degrees of radial deviance of the wrist
6 weeks
wrist radial deviation
Time Frame: 12 weeks
degrees of radial deviance of the wrist
12 weeks
MCP, DIP, PIP of digits 2-5: Flexion
Time Frame: initial
degrees of flexion for MCP, DIP, and PIP of digits 2-5
initial
MCP, DIP, PIP of digits 2-5: Flexion
Time Frame: 3 weeks
degrees of flexion for MCP, DIP, and PIP of digits 2-5
3 weeks
MCP, DIP, PIP of digits 2-5: Flexion
Time Frame: 6 weeks
degrees of flexion for MCP, DIP, and PIP of digits 2-5
6 weeks
MCP, DIP, PIP of digits 2-5: Flexion
Time Frame: 12 weeks
degrees of flexion for MCP, DIP, and PIP of digits 2-5
12 weeks
MCP, DIP, PIP of digits 2-5: Extension
Time Frame: initial
degrees of extension for MCP, DIP, and PIP of digits 2-5
initial
MCP, DIP, PIP of digits 2-5: Extension
Time Frame: 3 weeks
degrees of extension for MCP, DIP, and PIP of digits 2-5
3 weeks
MCP, DIP, PIP of digits 2-5: Extension
Time Frame: 6 weeks
degrees of extension for MCP, DIP, and PIP of digits 2-5
6 weeks
MCP, DIP, PIP of digits 2-5: Extension
Time Frame: 12 weeks
degrees of extension for MCP, DIP, and PIP of digits 2-5
12 weeks
MCP, DIP, PIP of digits 2-5: abduction
Time Frame: initial
degrees of abduction for MCP, DIP, and PIP of digits 2-5
initial
MCP, DIP, PIP of digits 2-5: abduction
Time Frame: 3 weeks
degrees of abduction for MCP, DIP, and PIP of digits 2-5
3 weeks
MCP, DIP, PIP of digits 2-5: abduction
Time Frame: 6 weeks
degrees of abduction for MCP, DIP, and PIP of digits 2-5
6 weeks
MCP, DIP, PIP of digits 2-5: abduction
Time Frame: 12 weeks
degrees of abduction for MCP, DIP, and PIP of digits 2-5
12 weeks
MCP, DIP, PIP of digits 2-5: adduction
Time Frame: initial
degrees of adduction for MCP, DIP, and PIP of digits 2-5
initial
MCP, DIP, PIP of digits 2-5: adduction
Time Frame: 3 weeks
degrees of adduction for MCP, DIP, and PIP of digits 2-5
3 weeks
MCP, DIP, PIP of digits 2-5: adduction
Time Frame: 6 weeks
degrees of adduction for MCP, DIP, and PIP of digits 2-5
6 weeks
MCP, DIP, PIP of digits 2-5: adduction
Time Frame: 12 weeks
degrees of adduction for MCP, DIP, and PIP of digits 2-5
12 weeks
Thumb Opposition at MCP
Time Frame: initial
degrees of thumb opposition
initial
Thumb Opposition at MCP
Time Frame: 3 weeks
degrees of thumb opposition
3 weeks
Thumb Opposition at MCP
Time Frame: 6 weeks
degrees of thumb opposition
6 weeks
Thumb Opposition at MCP
Time Frame: 12 weeks
degrees of thumb opposition
12 weeks
Thumb extension at IP
Time Frame: initial
degrees of thumb IP extension
initial
Thumb extension at IP
Time Frame: 3 weeks
degrees of thumb IP extension
3 weeks
Thumb extension at IP
Time Frame: 6 weeks
degrees of thumb IP extension
6 weeks
Thumb extension at IP
Time Frame: 12 weeks
degrees of thumb IP extension
12 weeks
Thumb flexion at IP
Time Frame: initial
degrees of thumb IP flexion
initial
Thumb flexion at IP
Time Frame: 3 weeks
degrees of thumb IP flexion
3 weeks
Thumb flexion at IP
Time Frame: 6 weeks
degrees of thumb IP flexion
6 weeks
Thumb flexion at IP
Time Frame: 12 weeks
degrees of thumb IP flexion
12 weeks
Quick DASH Questionnaire
Time Frame: 6 weeks
patient-reported outcome survey that evaluates functionality and patient-perceived disability
6 weeks
Quick DASH Questionnaire
Time Frame: 12 weeks
patient-reported outcome survey that evaluates functionality and patient-perceived disability
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VAS Pain Scale
Time Frame: 3 weeks
visual analog pain scale
3 weeks
VAS Pain Scale
Time Frame: 6 weeks
visual analog pain scale
6 weeks
VAS Pain Scale
Time Frame: 12 weeks
visual analog pain scale
12 weeks
Complications
Time Frame: 3 weeks
list of adverse events
3 weeks
Complications
Time Frame: 6 weeks
list of adverse events
6 weeks
Complications
Time Frame: 12 weeks
list of adverse events
12 weeks
Edema Measurements
Time Frame: 3 weeks
measurements of noted edema to the study area
3 weeks
Edema Measurements
Time Frame: 6 weeks
measurements of noted edema to the study area
6 weeks
Edema Measurements
Time Frame: 12 weeks
measurements of noted edema to the study area
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Robert Wood Johnson Barnabas Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brielle Orthopedics
University Orthopedics Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian Katt, MD, Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2021000732

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: 1234
  2. Investigator's Brochure
    Information identifier: 1234
  3. Informed Consent Form
    Information identifier: 1234

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings