Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Sprain

Intervention / Treatment
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* Drug: Diprophos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diprophos<br>Patients having had a sprain of the long fingers, within 2 weeks of consultation. This group will receive a single injection of corticoids. | Drug: Diprophos<br>* Single subcutaneous injection of Diprophos, in the acute phase.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flexion/extension deficit | Evaluation of the maximal amplitude of the articulation, as measured by a goniometer. | Baseline (day of kenacort injection) | 
| Flexion/extension deficit | Evaluation of the maximal amplitude of the articulation, as measured by a goniometer. | 7 days after injection | 
| Flexion/extension deficit | Evaluation of the maximal amplitude of the articulation, as measured by a goniometer. | 30 days after injection | 
| Laxity in hyperextension | Evaluation of the maximal amplitude of the articulation, as measured by a goniometer. | Baseline (day of kenacort injection) | 
| Laxity in hyperextension | Evaluation of the maximal amplitude of the articulation, as measured by a goniometer. | 7 days after injection | 
| Laxity in hyperextension | Evaluation of the maximal amplitude of the articulation, as measured by a goniometer | 30 days after injection | 
| Diameter of the articulation | Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio | Baseline (day of kenacort injection) | 
| Diameter of the articulation | Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio | 7 days after injection | 
| Diameter of the articulation | Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio | 30 days after injection | 
| Prehension force | Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand. | Baseline (day of kenacort injection) | 
| Prehension force | Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand. | 7 days after injection | 
| Prehension force | Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand. | 30 days after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVA scale | Pain assessment at the level of the volar plate | 7 days after injection | 
| EVA scale | Pain assessment at the level of the volar plate | 30 days after injection | 
| Mini-DASH | Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand. | 7 days after injection | 
| Mini-DASH | Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand. | 30 days after injection | 
| Mitchigan Hand Questionnaire | Auto-evaluation of the patient regarding the functionality of his/her articulation | 7 days after injection | 
| Mitchigan Hand Questionnaire | Auto-evaluation of the patient regarding the functionality of his/her articulation | 30 days after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sprains of the proximal interphalangeal joints of the long fingers, Diprophos