- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916940
Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.
Randomized Controlled Prospective Study on the Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers (Thumb Excluded).
There is currently no real consensus on the optimal management of acute sprains of the proximal interphalangeal joint of the long fingers.
The aim of this study is to assess the beneficial effect of an injection of corticosteroids for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute phase). This treatment, if effective, might become the treatment of choice for these types of injuries, instead of a prolonged immobilization or a careful early mobilization.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brussels, Belgium, 1020
- CHU Brugmann
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Brussels, Belgium, 1040
- Clinique du Parc Leopold
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults over 18 years old
- Type I and II and III of the Eaton classification (except if fracture/luxation with more than 50% of the articular surface injured)
- Trauma of one articulation only
- Consultation within 2 weeks of trauma
Exclusion Criteria:
- Patients under 18 years old and over 80 years old
- Pregnant/nursing women
- Eaton classification Type II with a fracture affecting more than 50% of the articular surface, or persistant instability after reduction.
- Open wounds, nerve lesion with sensitive issue and any wound needing a surgical intervention
- Underlying pathologies: rhumatological, neurological, congenital (giving hyperextensive articulations as a result)
- Corticoids allergy
- Infection within the treated zone
- Trauma antecedents at the level of the tendons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diprophos
Patients having had a sprain of the long fingers, within 2 weeks of consultation.
This group will receive a single injection of corticoids.
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Single subcutaneous injection of Diprophos, in the acute phase.
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No Intervention: Control group
Patients having had a sprain of the long fingers (Eaton classification type I and II), within 2 weeks of consultation.
This group will receive the standard of care treatment, without injection of corticoids.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flexion/extension deficit
Time Frame: Baseline (day of kenacort injection)
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Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
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Baseline (day of kenacort injection)
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Flexion/extension deficit
Time Frame: 7 days after injection
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Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
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7 days after injection
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Flexion/extension deficit
Time Frame: 30 days after injection
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Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
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30 days after injection
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Laxity in hyperextension
Time Frame: Baseline (day of kenacort injection)
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Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
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Baseline (day of kenacort injection)
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Laxity in hyperextension
Time Frame: 7 days after injection
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Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
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7 days after injection
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Laxity in hyperextension
Time Frame: 30 days after injection
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Evaluation of the maximal amplitude of the articulation, as measured by a goniometer
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30 days after injection
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Diameter of the articulation
Time Frame: Baseline (day of kenacort injection)
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Oedema evaluation.
Collateral comparison with the same finger of the other hand: result expressed as a ratio
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Baseline (day of kenacort injection)
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Diameter of the articulation
Time Frame: 7 days after injection
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Oedema evaluation.
Collateral comparison with the same finger of the other hand: result expressed as a ratio
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7 days after injection
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Diameter of the articulation
Time Frame: 30 days after injection
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Oedema evaluation.
Collateral comparison with the same finger of the other hand: result expressed as a ratio
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30 days after injection
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Prehension force
Time Frame: Baseline (day of kenacort injection)
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Assessed by a dynamometer (Jamar hydraulic gauge).
Result expressed as a ratio with the prehension force of the non-injured hand.
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Baseline (day of kenacort injection)
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Prehension force
Time Frame: 7 days after injection
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Assessed by a dynamometer (Jamar hydraulic gauge).
Result expressed as a ratio with the prehension force of the non-injured hand.
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7 days after injection
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Prehension force
Time Frame: 30 days after injection
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Assessed by a dynamometer (Jamar hydraulic gauge).
Result expressed as a ratio with the prehension force of the non-injured hand.
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30 days after injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EVA scale
Time Frame: 7 days after injection
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Pain assessment at the level of the volar plate
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7 days after injection
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EVA scale
Time Frame: 30 days after injection
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Pain assessment at the level of the volar plate
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30 days after injection
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Mini-DASH
Time Frame: 7 days after injection
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Assessment of the return to daily life activities or sport activities.
Questionnaire of the Disabilities of the Arm, Shoulder and Hand.
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7 days after injection
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Mini-DASH
Time Frame: 30 days after injection
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Assessment of the return to daily life activities or sport activities.
Questionnaire of the Disabilities of the Arm, Shoulder and Hand.
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30 days after injection
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Mitchigan Hand Questionnaire
Time Frame: 7 days after injection
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Auto-evaluation of the patient regarding the functionality of his/her articulation
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7 days after injection
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Mitchigan Hand Questionnaire
Time Frame: 30 days after injection
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Auto-evaluation of the patient regarding the functionality of his/her articulation
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30 days after injection
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nader Chahidi, MD, Clinique du Parc Leopold
Publications and helpful links
General Publications
- Freiberg A, Pollard BA, Macdonald MR, Duncan MJ. Management of proximal interphalangeal joint injuries. J Trauma. 1999 Mar;46(3):523-8. doi: 10.1097/00005373-199903000-00033. No abstract available.
- Chalmer J, Blakeway M, Adams Z, Milan SJ. Conservative interventions for treating hyperextension injuries of the proximal interphalangeal joints of the fingers. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD009030. doi: 10.1002/14651858.CD009030.pub2.
- Paschos NK, Abuhemoud K, Gantsos A, Mitsionis GI, Georgoulis AD. Management of proximal interphalangeal joint hyperextension injuries: a randomized controlled trial. J Hand Surg Am. 2014 Mar;39(3):449-54. doi: 10.1016/j.jhsa.2013.11.038. Epub 2014 Feb 4.
- Micev AJ, Saucedo JM, Kalainov DM, Wang L, Ma M, Yaffe MA. Surgical Techniques for Correction of Traumatic Hyperextension Instability of the Proximal Interphalangeal Joint: A Biomechanical Study. J Hand Surg Am. 2015 Aug;40(8):1631-7. doi: 10.1016/j.jhsa.2015.05.011. Epub 2015 Jul 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-Diprophos-IPP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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