Clinical trial NCT05003596: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hand Injuries
Finger Injuries
Lead sponsor: Robert Wood Johnson Barnabas Health
Sponsor class: OTHER
Collaborators: name: Brielle Orthopedics
name: University Orthopedics Associates
First posted: 2021-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: wrist flexion
timeFrame: initial
measure: wrist flexion
timeFrame: 3 weeks
measure: wrist flexion
timeFrame: 6 weeks
measure: wrist flexion
timeFrame: 12 weeks
measure: wrist extension
timeFrame: 12 weeks
measure: wrist extension
timeFrame: 6 weeks
measure: wrist extension
timeFrame: 3 weeks
measure: wrist extension
timeFrame: initial
measure: hand supination
timeFrame: initial
measure: hand supination
timeFrame: 3 weeks
measure: hand supination
timeFrame: 6 weeks
measure: hand supination
timeFrame: 12 weeks
measure: hand pronation
timeFrame: initial
measure: hand pronation
timeFrame: 3 weeks
measure: hand pronation
timeFrame: 6 weeks
measure: hand pronation
timeFrame: 12 weeks
measure: wrist ulnar deviation
timeFrame: initial
measure: wrist ulnar deviation
timeFrame: 3 weeks
measure: wrist ulnar deviation
timeFrame: 6 weeks
measure: wrist ulnar deviation
timeFrame: 12 weeks
measure: wrist radial deviation
timeFrame: initial
measure: wrist radial deviation
timeFrame: 3 weeks
measure: wrist radial deviation
timeFrame: 6 weeks
measure: wrist radial deviation
timeFrame: 12 weeks
measure: MCP, DIP, PIP of digits 2-5: Flexion
timeFrame: initial
measure: MCP, DIP, PIP of digits 2-5: Flexion
timeFrame: 3 weeks
measure: MCP, DIP, PIP of digits 2-5: Flexion
timeFrame: 6 weeks
measure: MCP, DIP, PIP of digits 2-5: Flexion
timeFrame: 12 weeks
measure: MCP, DIP, PIP of digits 2-5: Extension
timeFrame: initial
measure: MCP, DIP, PIP of digits 2-5: Extension
timeFrame: 3 weeks
measure: MCP, DIP, PIP of digits 2-5: Extension
timeFrame: 6 weeks
measure: MCP, DIP, PIP of digits 2-5: Extension
timeFrame: 12 weeks
measure: MCP, DIP, PIP of digits 2-5: abduction
timeFrame: initial
measure: MCP, DIP, PIP of digits 2-5: abduction
timeFrame: 3 weeks
measure: MCP, DIP, PIP of digits 2-5: abduction
timeFrame: 6 weeks
measure: MCP, DIP, PIP of digits 2-5: abduction
timeFrame: 12 weeks
measure: MCP, DIP, PIP of digits 2-5: adduction
timeFrame: initial
measure: MCP, DIP, PIP of digits 2-5: adduction
timeFrame: 3 weeks
measure: MCP, DIP, PIP of digits 2-5: adduction
timeFrame: 6 weeks
measure: MCP, DIP, PIP of digits 2-5: adduction
timeFrame: 12 weeks
measure: Thumb Opposition at MCP
timeFrame: initial
measure: Thumb Opposition at MCP
timeFrame: 3 weeks
measure: Thumb Opposition at MCP
timeFrame: 6 weeks
measure: Thumb Opposition at MCP
timeFrame: 12 weeks
measure: Thumb extension at IP
timeFrame: initial
measure: Thumb extension at IP
timeFrame: 3 weeks
measure: Thumb extension at IP
timeFrame: 6 weeks
measure: Thumb extension at IP
timeFrame: 12 weeks
measure: Thumb flexion at IP
timeFrame: initial
measure: Thumb flexion at IP
timeFrame: 3 weeks
measure: Thumb flexion at IP
timeFrame: 6 weeks
measure: Thumb flexion at IP
timeFrame: 12 weeks
measure: Quick DASH Questionnaire
timeFrame: 6 weeks
measure: Quick DASH Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: VAS Pain Scale
timeFrame: 3 weeks
measure: VAS Pain Scale
timeFrame: 6 weeks
measure: VAS Pain Scale
timeFrame: 12 weeks
measure: Complications
timeFrame: 3 weeks
measure: Complications
timeFrame: 6 weeks
measure: Complications
timeFrame: 12 weeks
measure: Edema Measurements
timeFrame: 3 weeks
measure: Edema Measurements
timeFrame: 6 weeks
measure: Edema Measurements
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brick
country: United States
facility: Brielle Orthopedics
state: New Jersey
city: Somerset
country: United States
facility: University Orthopedics Associates
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Brian Katt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.