Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- wrist flexion [initial]
degrees of wrist flexion
- wrist flexion [3 weeks]
degrees of wrist flexion
- wrist flexion [6 weeks]
degrees of wrist flexion
- wrist flexion [12 weeks]
degrees of wrist flexion
- wrist extension [12 weeks]
degrees of wrist extension
- wrist extension [6 weeks]
degrees of wrist extension
- wrist extension [3 weeks]
degrees of wrist extension
- wrist extension [initial]
degrees of wrist extension
- hand supination [initial]
degrees of hand supination
- hand supination [3 weeks]
degrees of hand supination
- hand supination [6 weeks]
degrees of hand supination
- hand supination [12 weeks]
degrees of hand supination
- hand pronation [initial]
degrees of hand pronation
- hand pronation [3 weeks]
degrees of hand pronation
- hand pronation [6 weeks]
degrees of hand pronation
- hand pronation [12 weeks]
degrees of hand pronation
- wrist ulnar deviation [initial]
degrees of wrist ulnar deviance
- wrist ulnar deviation [3 weeks]
degrees of wrist ulnar deviance
- wrist ulnar deviation [6 weeks]
degrees of wrist ulnar deviance
- wrist ulnar deviation [12 weeks]
degrees of wrist ulnar deviance
- wrist radial deviation [initial]
degrees of radial deviance of the wrist
- wrist radial deviation [3 weeks]
degrees of radial deviance of the wrist
- wrist radial deviation [6 weeks]
degrees of radial deviance of the wrist
- wrist radial deviation [12 weeks]
degrees of radial deviance of the wrist
- MCP, DIP, PIP of digits 2-5: Flexion [initial]
degrees of flexion for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: Flexion [3 weeks]
degrees of flexion for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: Flexion [6 weeks]
degrees of flexion for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: Flexion [12 weeks]
degrees of flexion for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: Extension [initial]
degrees of extension for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: Extension [3 weeks]
degrees of extension for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: Extension [6 weeks]
degrees of extension for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: Extension [12 weeks]
degrees of extension for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: abduction [initial]
degrees of abduction for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: abduction [3 weeks]
degrees of abduction for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: abduction [6 weeks]
degrees of abduction for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: abduction [12 weeks]
degrees of abduction for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: adduction [initial]
degrees of adduction for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: adduction [3 weeks]
degrees of adduction for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: adduction [6 weeks]
degrees of adduction for MCP, DIP, and PIP of digits 2-5
- MCP, DIP, PIP of digits 2-5: adduction [12 weeks]
degrees of adduction for MCP, DIP, and PIP of digits 2-5
- Thumb Opposition at MCP [initial]
degrees of thumb opposition
- Thumb Opposition at MCP [3 weeks]
degrees of thumb opposition
- Thumb Opposition at MCP [6 weeks]
degrees of thumb opposition
- Thumb Opposition at MCP [12 weeks]
degrees of thumb opposition
- Thumb extension at IP [initial]
degrees of thumb IP extension
- Thumb extension at IP [3 weeks]
degrees of thumb IP extension
- Thumb extension at IP [6 weeks]
degrees of thumb IP extension
- Thumb extension at IP [12 weeks]
degrees of thumb IP extension
- Thumb flexion at IP [initial]
degrees of thumb IP flexion
- Thumb flexion at IP [3 weeks]
degrees of thumb IP flexion
- Thumb flexion at IP [6 weeks]
degrees of thumb IP flexion
- Thumb flexion at IP [12 weeks]
degrees of thumb IP flexion
- Quick DASH Questionnaire [6 weeks]
patient-reported outcome survey that evaluates functionality and patient-perceived disability
- Quick DASH Questionnaire [12 weeks]
patient-reported outcome survey that evaluates functionality and patient-perceived disability
Secondary Outcome Measures
- VAS Pain Scale [3 weeks]
visual analog pain scale
- VAS Pain Scale [6 weeks]
visual analog pain scale
- VAS Pain Scale [12 weeks]
visual analog pain scale
- Complications [3 weeks]
list of adverse events
- Complications [6 weeks]
list of adverse events
- Complications [12 weeks]
list of adverse events
- Edema Measurements [3 weeks]
measurements of noted edema to the study area
- Edema Measurements [6 weeks]
measurements of noted edema to the study area
- Edema Measurements [12 weeks]
measurements of noted edema to the study area
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brielle Orthopedics | Brick | New Jersey | United States | 08724 |
| 2 | University Orthopedics Associates | Somerset | New Jersey | United States | 08873 |
Sponsors and Collaborators
- Robert Wood Johnson Barnabas Health
- Brielle Orthopedics
- University Orthopedics Associates
Investigators
- Principal Investigator: Brian Katt, MD, Rutgers, The State University of New Jersey
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- Pro2021000732