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

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: Not yet recruiting
• Conditions: Finger Injuries; Hand Injuries
• Intervention / Treatment: Drug: Methylprednisolone Tablet; Other: Standard Mobilization Treatment

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Bobby Varghese, MD; Phone Number: 8324657112; Email: bv209@rwjms.rutgers.edu
• Study Contact Backup: Name: Anna Green, MD; Email: annagreen7@gmail.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Pain Scale	visual analog pain scale	3 weeks
VAS Pain Scale	visual analog pain scale	6 weeks
VAS Pain Scale	visual analog pain scale	12 weeks
Complications	list of adverse events	3 weeks
Complications	list of adverse events	6 weeks
Complications	list of adverse events	12 weeks
Edema Measurements	measurements of noted edema to the study area	3 weeks
Edema Measurements	measurements of noted edema to the study area	6 weeks
Edema Measurements	measurements of noted edema to the study area	12 weeks

Collaborators and Investigators

• Sponsor: Robert Wood Johnson Barnabas Health
• Collaborators: Brielle Orthopedics; University Orthopedics Associates
• Investigators: Principal Investigator: Brian Katt, MD, Rutgers, The State University of New Jersey

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Rutgers REDCap server that stores study data
• Rutgers Onedrive to store data

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Finger Injuries; Hand Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Narcotics
• Other Study ID 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