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

Phase 2

Completed

• Conditions: Sprain
• Interventions: Drug: Diprophos

• Registration Number: NCT02916940
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Study Start: 2016-11-16
• Primary Completion: 2020-02-11
• Study Completion: 2020-02-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diprophos	Diprophos	Patients having had a sprain of the long fingers, within 2 weeks of consultation. This group will receive a single injection of corticoids.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHU Brugmann; 🇧🇪 Brussels, Belgium

Clinique du Parc Leopold; 🇧🇪 Brussels, Belgium