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

NCT ID: NCT05003596

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-09-01

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.

Conditions

Hand Injuries; Finger Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Methylprednisolone Tablet

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Standard Mobilization Treatment

Intervention Type: OTHER

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

Interventions

Methylprednisolone Tablet

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Solu-Medrol Dosepak; buddy taping; finger splint; tylenol; narcotics

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brielle Orthopedics

UNKNOWN

Sponsor Role: collaborator

University Orthopedics Associates

UNKNOWN

Sponsor Role: collaborator

Robert Wood Johnson Barnabas Health

OTHER

Sponsor Role: lead

Responsible Party

Bobby Varghese

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Katt, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Brielle Orthopedics

Brick, New Jersey, United States

University Orthopedics Associates

Somerset, New Jersey, United States

Countries

United States

Central Contacts

Bobby Varghese, MD

Role: CONTACT

bv209@rwjms.rutgers.edu

8324657112

Anna Green, MD

Role: CONTACT

annagreen7@gmail.com

Facility Contacts

Michelle Bettino

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 25564196 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29747624 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2395047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19240368 (View on PubMed)

Related Links

http://redcap.rwjms.rutgers.edu

Rutgers REDCap server that stores study data

Other Identifiers

Pro2021000732

Identifier Type: -

Identifier Source: org_study_id