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

Primary Purpose

Hand Injuries, Finger Injuries

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone Tablet
Standard Mobilization Treatment
Sponsored by
Robert Wood Johnson Barnabas Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Brielle Orthopedics
  • University Orthopedics Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Steroid Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 28, 2021
Last Updated
August 5, 2021
Sponsor
Robert Wood Johnson Barnabas Health
Collaborators
Brielle Orthopedics, University Orthopedics Associates
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1. Study Identification

Unique Protocol Identification Number
NCT05003596
Brief Title
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand
Official Title
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Robert Wood Johnson Barnabas Health
Collaborators
Brielle Orthopedics, University Orthopedics Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries, Finger Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
data without intervention identification will be analyzed by outcome assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steroid Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Tablet
Other Intervention Name(s)
Solu-Medrol Dosepak
Intervention Description
Subjects will take a quantity 21 4mg tablets over a 6 week taper.
Intervention Type
Other
Intervention Name(s)
Standard Mobilization Treatment
Other Intervention Name(s)
buddy taping, finger splint, tylenol, narcotics
Intervention Description
standard treatment of hand injuries with focus on mobilization. No anti-inflammatory medications. Pain management via Tylenol or narcotics if deemed necessary.
Primary Outcome Measure Information:
Title
wrist flexion
Description
degrees of wrist flexion
Time Frame
initial
Title
wrist flexion
Description
degrees of wrist flexion
Time Frame
3 weeks
Title
wrist flexion
Description
degrees of wrist flexion
Time Frame
6 weeks
Title
wrist flexion
Description
degrees of wrist flexion
Time Frame
12 weeks
Title
wrist extension
Description
degrees of wrist extension
Time Frame
12 weeks
Title
wrist extension
Description
degrees of wrist extension
Time Frame
6 weeks
Title
wrist extension
Description
degrees of wrist extension
Time Frame
3 weeks
Title
wrist extension
Description
degrees of wrist extension
Time Frame
initial
Title
hand supination
Description
degrees of hand supination
Time Frame
initial
Title
hand supination
Description
degrees of hand supination
Time Frame
3 weeks
Title
hand supination
Description
degrees of hand supination
Time Frame
6 weeks
Title
hand supination
Description
degrees of hand supination
Time Frame
12 weeks
Title
hand pronation
Description
degrees of hand pronation
Time Frame
initial
Title
hand pronation
Description
degrees of hand pronation
Time Frame
3 weeks
Title
hand pronation
Description
degrees of hand pronation
Time Frame
6 weeks
Title
hand pronation
Description
degrees of hand pronation
Time Frame
12 weeks
Title
wrist ulnar deviation
Description
degrees of wrist ulnar deviance
Time Frame
initial
Title
wrist ulnar deviation
Description
degrees of wrist ulnar deviance
Time Frame
3 weeks
Title
wrist ulnar deviation
Description
degrees of wrist ulnar deviance
Time Frame
6 weeks
Title
wrist ulnar deviation
Description
degrees of wrist ulnar deviance
Time Frame
12 weeks
Title
wrist radial deviation
Description
degrees of radial deviance of the wrist
Time Frame
initial
Title
wrist radial deviation
Description
degrees of radial deviance of the wrist
Time Frame
3 weeks
Title
wrist radial deviation
Description
degrees of radial deviance of the wrist
Time Frame
6 weeks
Title
wrist radial deviation
Description
degrees of radial deviance of the wrist
Time Frame
12 weeks
Title
MCP, DIP, PIP of digits 2-5: Flexion
Description
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Time Frame
initial
Title
MCP, DIP, PIP of digits 2-5: Flexion
Description
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Time Frame
3 weeks
Title
MCP, DIP, PIP of digits 2-5: Flexion
Description
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Time Frame
6 weeks
Title
MCP, DIP, PIP of digits 2-5: Flexion
Description
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Time Frame
12 weeks
Title
MCP, DIP, PIP of digits 2-5: Extension
Description
degrees of extension for MCP, DIP, and PIP of digits 2-5
Time Frame
initial
Title
MCP, DIP, PIP of digits 2-5: Extension
Description
degrees of extension for MCP, DIP, and PIP of digits 2-5
Time Frame
3 weeks
Title
MCP, DIP, PIP of digits 2-5: Extension
Description
degrees of extension for MCP, DIP, and PIP of digits 2-5
Time Frame
6 weeks
Title
MCP, DIP, PIP of digits 2-5: Extension
Description
degrees of extension for MCP, DIP, and PIP of digits 2-5
Time Frame
12 weeks
Title
MCP, DIP, PIP of digits 2-5: abduction
Description
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Time Frame
initial
Title
MCP, DIP, PIP of digits 2-5: abduction
Description
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Time Frame
3 weeks
Title
MCP, DIP, PIP of digits 2-5: abduction
Description
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Time Frame
6 weeks
Title
MCP, DIP, PIP of digits 2-5: abduction
Description
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Time Frame
12 weeks
Title
MCP, DIP, PIP of digits 2-5: adduction
Description
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Time Frame
initial
Title
MCP, DIP, PIP of digits 2-5: adduction
Description
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Time Frame
3 weeks
Title
MCP, DIP, PIP of digits 2-5: adduction
Description
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Time Frame
6 weeks
Title
MCP, DIP, PIP of digits 2-5: adduction
Description
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Time Frame
12 weeks
Title
Thumb Opposition at MCP
Description
degrees of thumb opposition
Time Frame
initial
Title
Thumb Opposition at MCP
Description
degrees of thumb opposition
Time Frame
3 weeks
Title
Thumb Opposition at MCP
Description
degrees of thumb opposition
Time Frame
6 weeks
Title
Thumb Opposition at MCP
Description
degrees of thumb opposition
Time Frame
12 weeks
Title
Thumb extension at IP
Description
degrees of thumb IP extension
Time Frame
initial
Title
Thumb extension at IP
Description
degrees of thumb IP extension
Time Frame
3 weeks
Title
Thumb extension at IP
Description
degrees of thumb IP extension
Time Frame
6 weeks
Title
Thumb extension at IP
Description
degrees of thumb IP extension
Time Frame
12 weeks
Title
Thumb flexion at IP
Description
degrees of thumb IP flexion
Time Frame
initial
Title
Thumb flexion at IP
Description
degrees of thumb IP flexion
Time Frame
3 weeks
Title
Thumb flexion at IP
Description
degrees of thumb IP flexion
Time Frame
6 weeks
Title
Thumb flexion at IP
Description
degrees of thumb IP flexion
Time Frame
12 weeks
Title
Quick DASH Questionnaire
Description
patient-reported outcome survey that evaluates functionality and patient-perceived disability
Time Frame
6 weeks
Title
Quick DASH Questionnaire
Description
patient-reported outcome survey that evaluates functionality and patient-perceived disability
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
VAS Pain Scale
Description
visual analog pain scale
Time Frame
3 weeks
Title
VAS Pain Scale
Description
visual analog pain scale
Time Frame
6 weeks
Title
VAS Pain Scale
Description
visual analog pain scale
Time Frame
12 weeks
Title
Complications
Description
list of adverse events
Time Frame
3 weeks
Title
Complications
Description
list of adverse events
Time Frame
6 weeks
Title
Complications
Description
list of adverse events
Time Frame
12 weeks
Title
Edema Measurements
Description
measurements of noted edema to the study area
Time Frame
3 weeks
Title
Edema Measurements
Description
measurements of noted edema to the study area
Time Frame
6 weeks
Title
Edema Measurements
Description
measurements of noted edema to the study area
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bobby Varghese, MD
Phone
8324657112
Email
bv209@rwjms.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Green, MD
Email
annagreen7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Katt, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brielle Orthopedics
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Bettino
First Name & Middle Initial & Last Name & Degree
Brian Katt, MD
Facility Name
University Orthopedics Associates
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25564196
Citation
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.
Results Reference
background
PubMed Identifier
29747624
Citation
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.
Results Reference
background
PubMed Identifier
2395047
Citation
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.
Results Reference
background
PubMed Identifier
19240368
Citation
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.
Results Reference
background
Links:
URL
http://redcap.rwjms.rutgers.edu
Description
Rutgers REDCap server that stores study data
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://rutgersconnect-my.sharepoint.com/:w:/g/personal/bv209_rwjms_rutgers_edu/EZ3kJkdhk6NFrYK2hjadzw0BS_5CuFLYGpUSEuUo5nQNuQ?e=3zvLqi
Available IPD/Information Identifier
1234
Available IPD/Information Type
Investigator's Brochure
Available IPD/Information URL
https://rutgersconnect-my.sharepoint.com/:w:/g/personal/bv209_rwjms_rutgers_edu/EcBK1H-MbfBOrsjEdCgD1pIBaPsIhycLwTZMfI2yS5XLuw?e=jEuWre
Available IPD/Information Identifier
1234
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://rutgersconnect-my.sharepoint.com/:w:/g/personal/bv209_rwjms_rutgers_edu/EYGTPLVTDPpHpxUPCs9SkawBpt4_rXhWlCZ0emBBz44kTw?e=maOqnR
Available IPD/Information Identifier
1234

Learn more about this trial

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

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