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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Bobby Varghese, MD contact

8324657112

bv209@rwjms.rutgers.edu

Anna Green, MD contact

annagreen7@gmail.com

United States2 sites

  • Brielle Orthopedics

    Brick, New Jersey, 08724

    Michelle Bettino

    Brian Katt, MD

  • University Orthopedics Associates

    Somerset, New Jersey, 08873

Other trials in United States

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.

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 groups in NCT05003596
Study groupRoleWhat they receive
Steroid GroupExperimentalPatients 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 GroupActive comparatorPatients 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.

  1. wrist flexion

    degrees of wrist flexion

    Measured: initial

  2. wrist flexion

    degrees of wrist flexion

    Measured: 3 weeks

  3. wrist flexion

    degrees of wrist flexion

    Measured: 6 weeks

  4. wrist flexion

    degrees of wrist flexion

    Measured: 12 weeks

  5. wrist extension

    degrees of wrist extension

    Measured: 12 weeks

  6. wrist extension

    degrees of wrist extension

    Measured: 6 weeks

  7. wrist extension

    degrees of wrist extension

    Measured: 3 weeks

  8. wrist extension

    degrees of wrist extension

    Measured: initial

  9. hand supination

    degrees of hand supination

    Measured: initial

  10. hand supination

    degrees of hand supination

    Measured: 3 weeks

  11. hand supination

    degrees of hand supination

    Measured: 6 weeks

  12. hand supination

    degrees of hand supination

    Measured: 12 weeks

  13. hand pronation

    degrees of hand pronation

    Measured: initial

  14. hand pronation

    degrees of hand pronation

    Measured: 3 weeks

  15. hand pronation

    degrees of hand pronation

    Measured: 6 weeks

  16. hand pronation

    degrees of hand pronation

    Measured: 12 weeks

  17. wrist ulnar deviation

    degrees of wrist ulnar deviance

    Measured: initial

  18. wrist ulnar deviation

    degrees of wrist ulnar deviance

    Measured: 3 weeks

  19. wrist ulnar deviation

    degrees of wrist ulnar deviance

    Measured: 6 weeks

  20. wrist ulnar deviation

    degrees of wrist ulnar deviance

    Measured: 12 weeks

  21. wrist radial deviation

    degrees of radial deviance of the wrist

    Measured: initial

  22. wrist radial deviation

    degrees of radial deviance of the wrist

    Measured: 3 weeks

  23. wrist radial deviation

    degrees of radial deviance of the wrist

    Measured: 6 weeks

  24. wrist radial deviation

    degrees of radial deviance of the wrist

    Measured: 12 weeks

  25. MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    Measured: initial

  26. MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    Measured: 3 weeks

  27. MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    Measured: 6 weeks

  28. MCP, DIP, PIP of digits 2-5: Flexion

    degrees of flexion for MCP, DIP, and PIP of digits 2-5

    Measured: 12 weeks

  29. MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    Measured: initial

  30. MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    Measured: 3 weeks

  31. MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    Measured: 6 weeks

  32. MCP, DIP, PIP of digits 2-5: Extension

    degrees of extension for MCP, DIP, and PIP of digits 2-5

    Measured: 12 weeks

  33. MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    Measured: initial

  34. MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    Measured: 3 weeks

  35. MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    Measured: 6 weeks

  36. MCP, DIP, PIP of digits 2-5: abduction

    degrees of abduction for MCP, DIP, and PIP of digits 2-5

    Measured: 12 weeks

  37. MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    Measured: initial

  38. MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    Measured: 3 weeks

  39. MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    Measured: 6 weeks

  40. MCP, DIP, PIP of digits 2-5: adduction

    degrees of adduction for MCP, DIP, and PIP of digits 2-5

    Measured: 12 weeks

  41. Thumb Opposition at MCP

    degrees of thumb opposition

    Measured: initial

  42. Thumb Opposition at MCP

    degrees of thumb opposition

    Measured: 3 weeks

  43. Thumb Opposition at MCP

    degrees of thumb opposition

    Measured: 6 weeks

  44. Thumb Opposition at MCP

    degrees of thumb opposition

    Measured: 12 weeks

  45. Thumb extension at IP

    degrees of thumb IP extension

    Measured: initial

  46. Thumb extension at IP

    degrees of thumb IP extension

    Measured: 3 weeks

  47. Thumb extension at IP

    degrees of thumb IP extension

    Measured: 6 weeks

  48. Thumb extension at IP

    degrees of thumb IP extension

    Measured: 12 weeks

  49. Thumb flexion at IP

    degrees of thumb IP flexion

    Measured: initial

  50. Thumb flexion at IP

    degrees of thumb IP flexion

    Measured: 3 weeks

  51. Thumb flexion at IP

    degrees of thumb IP flexion

    Measured: 6 weeks

  52. Thumb flexion at IP

    degrees of thumb IP flexion

    Measured: 12 weeks

  53. Quick DASH Questionnaire

    patient-reported outcome survey that evaluates functionality and patient-perceived disability

    Measured: 6 weeks

  54. Quick DASH Questionnaire

    patient-reported outcome survey that evaluates functionality and patient-perceived disability

    Measured: 12 weeks

Secondary outcomes (9)

  1. VAS Pain Scale

    visual analog pain scale

    Measured: 3 weeks

  2. VAS Pain Scale

    visual analog pain scale

    Measured: 6 weeks

  3. VAS Pain Scale

    visual analog pain scale

    Measured: 12 weeks

  4. Complications

    list of adverse events

    Measured: 3 weeks

  5. Complications

    list of adverse events

    Measured: 6 weeks

  6. Complications

    list of adverse events

    Measured: 12 weeks

  7. Edema Measurements

    measurements of noted edema to the study area

    Measured: 3 weeks

  8. Edema Measurements

    measurements of noted edema to the study area

    Measured: 6 weeks

  9. 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.

  1. First posted12 Aug 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 Sep 2023 (estimated)

Resources

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)
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 25564196

  • 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.

    PubMed 29747624

  • 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.

    PubMed 2395047

  • 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.

    PubMed 19240368

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.

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