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

Hand Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05003596
• Other study ID #: Pro2021000732
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2021
• Source: Robert Wood Johnson Barnabas Health
• Contact: Bobby Varghese, MD
• Phone: 8324657112
• Email: bv209[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Finger Injuries
• Hand Injuries
• Wounds and Injuries

Intervention

Drug:
• Methylprednisolone Tablet
Subjects will take a quantity 21 4mg tablets over a 6 week taper.

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.

Locations

Country	Name	City	State
United States	Brielle Orthopedics	Brick	New Jersey
United States	University Orthopedics Associates	Somerset	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Robert Wood Johnson Barnabas Health	Brielle Orthopedics, University Orthopedics Associates

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wrist flexion	degrees of wrist flexion	initial
Primary	wrist flexion	degrees of wrist flexion	3 weeks
Primary	wrist flexion	degrees of wrist flexion	6 weeks
Primary	wrist flexion	degrees of wrist flexion	12 weeks
Primary	wrist extension	degrees of wrist extension	12 weeks
Primary	wrist extension	degrees of wrist extension	6 weeks
Primary	wrist extension	degrees of wrist extension	3 weeks
Primary	wrist extension	degrees of wrist extension	initial
Primary	hand supination	degrees of hand supination	initial
Primary	hand supination	degrees of hand supination	3 weeks
Primary	hand supination	degrees of hand supination	6 weeks
Primary	hand supination	degrees of hand supination	12 weeks
Primary	hand pronation	degrees of hand pronation	initial
Primary	hand pronation	degrees of hand pronation	3 weeks
Primary	hand pronation	degrees of hand pronation	6 weeks
Primary	hand pronation	degrees of hand pronation	12 weeks
Primary	wrist ulnar deviation	degrees of wrist ulnar deviance	initial
Primary	wrist ulnar deviation	degrees of wrist ulnar deviance	3 weeks
Primary	wrist ulnar deviation	degrees of wrist ulnar deviance	6 weeks
Primary	wrist ulnar deviation	degrees of wrist ulnar deviance	12 weeks
Primary	wrist radial deviation	degrees of radial deviance of the wrist	initial
Primary	wrist radial deviation	degrees of radial deviance of the wrist	3 weeks
Primary	wrist radial deviation	degrees of radial deviance of the wrist	6 weeks
Primary	wrist radial deviation	degrees of radial deviance of the wrist	12 weeks
Primary	MCP, DIP, PIP of digits 2-5: Flexion	degrees of flexion for MCP, DIP, and PIP of digits 2-5	initial
Primary	MCP, DIP, PIP of digits 2-5: Flexion	degrees of flexion for MCP, DIP, and PIP of digits 2-5	3 weeks
Primary	MCP, DIP, PIP of digits 2-5: Flexion	degrees of flexion for MCP, DIP, and PIP of digits 2-5	6 weeks
Primary	MCP, DIP, PIP of digits 2-5: Flexion	degrees of flexion for MCP, DIP, and PIP of digits 2-5	12 weeks
Primary	MCP, DIP, PIP of digits 2-5: Extension	degrees of extension for MCP, DIP, and PIP of digits 2-5	initial
Primary	MCP, DIP, PIP of digits 2-5: Extension	degrees of extension for MCP, DIP, and PIP of digits 2-5	3 weeks
Primary	MCP, DIP, PIP of digits 2-5: Extension	degrees of extension for MCP, DIP, and PIP of digits 2-5	6 weeks
Primary	MCP, DIP, PIP of digits 2-5: Extension	degrees of extension for MCP, DIP, and PIP of digits 2-5	12 weeks
Primary	MCP, DIP, PIP of digits 2-5: abduction	degrees of abduction for MCP, DIP, and PIP of digits 2-5	initial
Primary	MCP, DIP, PIP of digits 2-5: abduction	degrees of abduction for MCP, DIP, and PIP of digits 2-5	3 weeks
Primary	MCP, DIP, PIP of digits 2-5: abduction	degrees of abduction for MCP, DIP, and PIP of digits 2-5	6 weeks
Primary	MCP, DIP, PIP of digits 2-5: abduction	degrees of abduction for MCP, DIP, and PIP of digits 2-5	12 weeks
Primary	MCP, DIP, PIP of digits 2-5: adduction	degrees of adduction for MCP, DIP, and PIP of digits 2-5	initial
Primary	MCP, DIP, PIP of digits 2-5: adduction	degrees of adduction for MCP, DIP, and PIP of digits 2-5	3 weeks
Primary	MCP, DIP, PIP of digits 2-5: adduction	degrees of adduction for MCP, DIP, and PIP of digits 2-5	6 weeks
Primary	MCP, DIP, PIP of digits 2-5: adduction	degrees of adduction for MCP, DIP, and PIP of digits 2-5	12 weeks
Primary	Thumb Opposition at MCP	degrees of thumb opposition	initial
Primary	Thumb Opposition at MCP	degrees of thumb opposition	3 weeks
Primary	Thumb Opposition at MCP	degrees of thumb opposition	6 weeks
Primary	Thumb Opposition at MCP	degrees of thumb opposition	12 weeks
Primary	Thumb extension at IP	degrees of thumb IP extension	initial
Primary	Thumb extension at IP	degrees of thumb IP extension	3 weeks
Primary	Thumb extension at IP	degrees of thumb IP extension	6 weeks
Primary	Thumb extension at IP	degrees of thumb IP extension	12 weeks
Primary	Thumb flexion at IP	degrees of thumb IP flexion	initial
Primary	Thumb flexion at IP	degrees of thumb IP flexion	3 weeks
Primary	Thumb flexion at IP	degrees of thumb IP flexion	6 weeks
Primary	Thumb flexion at IP	degrees of thumb IP flexion	12 weeks
Primary	Quick DASH Questionnaire	patient-reported outcome survey that evaluates functionality and patient-perceived disability	6 weeks
Primary	Quick DASH Questionnaire	patient-reported outcome survey that evaluates functionality and patient-perceived disability	12 weeks
Secondary	VAS Pain Scale	visual analog pain scale	3 weeks
Secondary	VAS Pain Scale	visual analog pain scale	6 weeks
Secondary	VAS Pain Scale	visual analog pain scale	12 weeks
Secondary	Complications	list of adverse events	3 weeks
Secondary	Complications	list of adverse events	6 weeks
Secondary	Complications	list of adverse events	12 weeks
Secondary	Edema Measurements	measurements of noted edema to the study area	3 weeks
Secondary	Edema Measurements	measurements of noted edema to the study area	6 weeks
Secondary	Edema Measurements	measurements of noted edema to the study area	12 weeks

External Links

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