Hand InjuriesPhase 2/3NCT05003596
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand
A Phase 2/3 study testing Methylprednisolone Tablet and Standard Mobilization Treatment in people with Hand Injuries and Finger Injuries, run by Robert Wood Johnson Barnabas Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries, Finger Injuries
- What is being tested?
- Methylprednisolone Tablet and Standard Mobilization Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2021to 1 Sep 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with soft tissue injuries and stable fractures from the metacarpophalangeal joint to the distal phalanx
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Anna Green, MD contact
United States2 sites
Brielle Orthopedics
Brick, New Jersey, 08724
Michelle Bettino
Brian Katt, MD
University Orthopedics Associates
Somerset, New Jersey, 08873
About this study
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.
Read the 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
- Being tested
- Methylprednisolone Tablet, Standard Mobilization Treatment
- Medical subject headings
- Hand Injuries, Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone TabletDrug
Also called Solu-Medrol Dosepak
Subjects will take a quantity 21 4mg tablets over a 6 week taper.
Standard Mobilization TreatmentOther
Also called buddy taping, finger splint, tylenol, narcotics
standard treatment of hand injuries with focus on mobilization. No anti-inflammatory medications. Pain management via Tylenol or narcotics if deemed necessary.
| Study group | Role | What they receive |
|---|---|---|
| Steroid Group | Experimental | 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. Receives: Drug: Methylprednisolone Tablet |
| Control Group | Active comparator | 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. Receives: Other: Standard Mobilization Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
wrist flexion
degrees of wrist flexion
Measured: initial
wrist flexion
degrees of wrist flexion
Measured: 3 weeks
wrist flexion
degrees of wrist flexion
Measured: 6 weeks
wrist flexion
degrees of wrist flexion
Measured: 12 weeks
wrist extension
degrees of wrist extension
Measured: 12 weeks
wrist extension
degrees of wrist extension
Measured: 6 weeks
wrist extension
degrees of wrist extension
Measured: 3 weeks
wrist extension
degrees of wrist extension
Measured: initial
hand supination
degrees of hand supination
Measured: initial
hand supination
degrees of hand supination
Measured: 3 weeks
hand supination
degrees of hand supination
Measured: 6 weeks
hand supination
degrees of hand supination
Measured: 12 weeks
hand pronation
degrees of hand pronation
Measured: initial
hand pronation
degrees of hand pronation
Measured: 3 weeks
hand pronation
degrees of hand pronation
Measured: 6 weeks
hand pronation
degrees of hand pronation
Measured: 12 weeks
wrist ulnar deviation
degrees of wrist ulnar deviance
Measured: initial
wrist ulnar deviation
degrees of wrist ulnar deviance
Measured: 3 weeks
wrist ulnar deviation
degrees of wrist ulnar deviance
Measured: 6 weeks
wrist ulnar deviation
degrees of wrist ulnar deviance
Measured: 12 weeks
wrist radial deviation
degrees of radial deviance of the wrist
Measured: initial
wrist radial deviation
degrees of radial deviance of the wrist
Measured: 3 weeks
wrist radial deviation
degrees of radial deviance of the wrist
Measured: 6 weeks
wrist radial deviation
degrees of radial deviance of the wrist
Measured: 12 weeks
MCP, DIP, PIP of digits 2-5: Flexion
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Measured: initial
MCP, DIP, PIP of digits 2-5: Flexion
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Measured: 3 weeks
MCP, DIP, PIP of digits 2-5: Flexion
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Measured: 6 weeks
MCP, DIP, PIP of digits 2-5: Flexion
degrees of flexion for MCP, DIP, and PIP of digits 2-5
Measured: 12 weeks
MCP, DIP, PIP of digits 2-5: Extension
degrees of extension for MCP, DIP, and PIP of digits 2-5
Measured: initial
MCP, DIP, PIP of digits 2-5: Extension
degrees of extension for MCP, DIP, and PIP of digits 2-5
Measured: 3 weeks
MCP, DIP, PIP of digits 2-5: Extension
degrees of extension for MCP, DIP, and PIP of digits 2-5
Measured: 6 weeks
MCP, DIP, PIP of digits 2-5: Extension
degrees of extension for MCP, DIP, and PIP of digits 2-5
Measured: 12 weeks
MCP, DIP, PIP of digits 2-5: abduction
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Measured: initial
MCP, DIP, PIP of digits 2-5: abduction
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Measured: 3 weeks
MCP, DIP, PIP of digits 2-5: abduction
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Measured: 6 weeks
MCP, DIP, PIP of digits 2-5: abduction
degrees of abduction for MCP, DIP, and PIP of digits 2-5
Measured: 12 weeks
MCP, DIP, PIP of digits 2-5: adduction
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Measured: initial
MCP, DIP, PIP of digits 2-5: adduction
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Measured: 3 weeks
MCP, DIP, PIP of digits 2-5: adduction
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Measured: 6 weeks
MCP, DIP, PIP of digits 2-5: adduction
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Measured: 12 weeks
Thumb Opposition at MCP
degrees of thumb opposition
Measured: initial
Thumb Opposition at MCP
degrees of thumb opposition
Measured: 3 weeks
Thumb Opposition at MCP
degrees of thumb opposition
Measured: 6 weeks
Thumb Opposition at MCP
degrees of thumb opposition
Measured: 12 weeks
Thumb extension at IP
degrees of thumb IP extension
Measured: initial
Thumb extension at IP
degrees of thumb IP extension
Measured: 3 weeks
Thumb extension at IP
degrees of thumb IP extension
Measured: 6 weeks
Thumb extension at IP
degrees of thumb IP extension
Measured: 12 weeks
Thumb flexion at IP
degrees of thumb IP flexion
Measured: initial
Thumb flexion at IP
degrees of thumb IP flexion
Measured: 3 weeks
Thumb flexion at IP
degrees of thumb IP flexion
Measured: 6 weeks
Thumb flexion at IP
degrees of thumb IP flexion
Measured: 12 weeks
Quick DASH Questionnaire
patient-reported outcome survey that evaluates functionality and patient-perceived disability
Measured: 6 weeks
Quick DASH Questionnaire
patient-reported outcome survey that evaluates functionality and patient-perceived disability
Measured: 12 weeks
Secondary outcomes (9)
VAS Pain Scale
visual analog pain scale
Measured: 3 weeks
VAS Pain Scale
visual analog pain scale
Measured: 6 weeks
VAS Pain Scale
visual analog pain scale
Measured: 12 weeks
Complications
list of adverse events
Measured: 3 weeks
Complications
list of adverse events
Measured: 6 weeks
Complications
list of adverse events
Measured: 12 weeks
Edema Measurements
measurements of noted edema to the study area
Measured: 3 weeks
Edema Measurements
measurements of noted edema to the study area
Measured: 6 weeks
Edema Measurements
measurements of noted edema to the study area
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Barnabas Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brielle Orthopedics, University Orthopedics Associates
- Responsible party
- Principal investigator, Bobby Varghese, Robert Wood Johnson Barnabas Health
- Investigators
- Brian Katt, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003596
- Sponsor's protocol ID
- Pro2021000732
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25564196Yang 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.
PubMed 29747624Troullos 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.
PubMed 2395047Boursinos 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.
PubMed 19240368
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand
- ClinicalTrials.gov ID
- NCT05003596
- Acronym / sponsor ID
- Pro2021000732
- Conditions
- Hand Injuries, Finger Injuries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Robert Wood Johnson Barnabas HealthUniversity, hospital or other
- Collaborators
- Brielle Orthopedics, University Orthopedics Associates
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid Group | Experimental | Drug: Methylprednisolone TabletPatients 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. |
| Control Group | Active comparator | Other: Standard Mobilization TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with soft tissue injuries and stable fractures from the metacarpophalangeal joint to the distal phalanx
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone TabletAlso: Solu-Medrol DosepakSubjects will take a quantity 21 4mg tablets over a 6 week taper. | Drug | Steroid Group |
| Standard Mobilization TreatmentAlso: buddy taping, finger splint, tylenol, narcoticsstandard treatment of hand injuries with focus on mobilization. No anti-inflammatory medications. Pain management via Tylenol or narcotics if deemed necessary. | Other | Control Group |
Primary outcome
wrist flexion
Time frame: initial
degrees of wrist flexion
wrist flexion
Time frame: 3 weeks
degrees of wrist flexion
wrist flexion
Time frame: 6 weeks
degrees of wrist flexion
wrist flexion
Time frame: 12 weeks
degrees of wrist flexion
wrist extension
Time frame: 12 weeks
degrees of wrist extension
wrist extension
Time frame: 6 weeks
degrees of wrist extension
wrist extension
Time frame: 3 weeks
degrees of wrist extension
wrist extension
Time frame: initial
degrees of wrist extension
hand supination
Time frame: initial
degrees of hand supination
hand supination
Time frame: 3 weeks
degrees of hand supination
hand supination
Time frame: 6 weeks
degrees of hand supination
hand supination
Time frame: 12 weeks
degrees of hand supination
hand pronation
Time frame: initial
degrees of hand pronation
hand pronation
Time frame: 3 weeks
degrees of hand pronation
hand pronation
Time frame: 6 weeks
degrees of hand pronation
hand pronation
Time frame: 12 weeks
degrees of hand pronation
wrist ulnar deviation
Time frame: initial
degrees of wrist ulnar deviance
wrist ulnar deviation
Time frame: 3 weeks
degrees of wrist ulnar deviance
wrist ulnar deviation
Time frame: 6 weeks
degrees of wrist ulnar deviance
wrist ulnar deviation
Time frame: 12 weeks
degrees of wrist ulnar deviance
wrist radial deviation
Time frame: initial
degrees of radial deviance of the wrist
wrist radial deviation
Time frame: 3 weeks
degrees of radial deviance of the wrist
wrist radial deviation
Time frame: 6 weeks
degrees of radial deviance of the wrist
wrist radial deviation
Time frame: 12 weeks
degrees of radial deviance of the wrist
MCP, DIP, PIP of digits 2-5: Flexion
Time frame: initial
degrees of flexion for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Flexion
Time frame: 3 weeks
degrees of flexion for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Flexion
Time frame: 6 weeks
degrees of flexion for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Flexion
Time frame: 12 weeks
degrees of flexion for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Extension
Time frame: initial
degrees of extension for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Extension
Time frame: 3 weeks
degrees of extension for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Extension
Time frame: 6 weeks
degrees of extension for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: Extension
Time frame: 12 weeks
degrees of extension for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: abduction
Time frame: initial
degrees of abduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: abduction
Time frame: 3 weeks
degrees of abduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: abduction
Time frame: 6 weeks
degrees of abduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: abduction
Time frame: 12 weeks
degrees of abduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: adduction
Time frame: initial
degrees of adduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: adduction
Time frame: 3 weeks
degrees of adduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: adduction
Time frame: 6 weeks
degrees of adduction for MCP, DIP, and PIP of digits 2-5
MCP, DIP, PIP of digits 2-5: adduction
Time frame: 12 weeks
degrees of adduction for MCP, DIP, and PIP of digits 2-5
Thumb Opposition at MCP
Time frame: initial
degrees of thumb opposition
Thumb Opposition at MCP
Time frame: 3 weeks
degrees of thumb opposition
Thumb Opposition at MCP
Time frame: 6 weeks
degrees of thumb opposition
Thumb Opposition at MCP
Time frame: 12 weeks
degrees of thumb opposition
Thumb extension at IP
Time frame: initial
degrees of thumb IP extension
Thumb extension at IP
Time frame: 3 weeks
degrees of thumb IP extension
Thumb extension at IP
Time frame: 6 weeks
degrees of thumb IP extension
Thumb extension at IP
Time frame: 12 weeks
degrees of thumb IP extension
Thumb flexion at IP
Time frame: initial
degrees of thumb IP flexion
Thumb flexion at IP
Time frame: 3 weeks
degrees of thumb IP flexion
Thumb flexion at IP
Time frame: 6 weeks
degrees of thumb IP flexion
Thumb flexion at IP
Time frame: 12 weeks
degrees of thumb IP flexion
Quick DASH Questionnaire
Time frame: 6 weeks
patient-reported outcome survey that evaluates functionality and patient-perceived disability
Quick DASH Questionnaire
Time frame: 12 weeks
patient-reported outcome survey that evaluates functionality and patient-perceived disability
9 secondary outcomes
VAS Pain Scale
Time frame: 3 weeks
VAS Pain Scale
Time frame: 6 weeks
VAS Pain Scale
Time frame: 12 weeks
Complications
Time frame: 3 weeks
Complications
Time frame: 6 weeks
Complications
Time frame: 12 weeks
Edema Measurements
Time frame: 3 weeks
Edema Measurements
Time frame: 6 weeks
Edema Measurements
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Background: PubMed 25564196Rytter 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.
- Background: PubMed 29747624Yang 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.
- Background: PubMed 2395047Troullos 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.
- Background: PubMed 19240368Boursinos 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.
- Rutgers REDCap server that stores study dataLink provided by the sponsor.
- Rutgers Onedrive to store dataLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Green, MD contact
Brian Katt, MD principal investigator
Rutgers, The State University of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylprednisolone Tablet and Standard Mobilization Treatment in people with Hand Injuries and Finger Injuries, run by Robert Wood Johnson Barnabas Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bobby Varghese, MD (8324657112, bv209@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wrist flexion (time frame: initial). The study lists 54 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003596, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.