Injection of corticoids for the treatment of sprains 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).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003875-22-BE

Enrollment

Registered

2016-11-09

Start date

2016-12-08

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute sprain of the proximal interphalangeal joints of the fingers

Interventions

Trade Name: Diprophos Pharmaceutical Form: Suspension for injection Trade Name: MARCAINE Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 53 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: - Assess the effect of corticoids in the acute treatment of the sprain of the proximal interphalangeal joints of the fingers. The future aim is to assess if corticoids can be used as a first choice treatment, instead of a long immobilization or a careful precocious mobilization.;Secondary Objective: Not applicable; Primary end point(s): - Deficit in flexion/extension as measured by the Goniometer ( 40°) - Hyperextension laxity ( 5°) as measured by the Goniometer - Diameter of the proximal interphalangeal joints of the fingers - Prehension force, as measured by the Dynamometer - Pain at the level of the volar plate, as assessed by the EVA pain scale - Mini-DASH questionnaire (Questionnaire of the Disabilities of the Arm, Shoulder and Hand score) - Michigan Hand questionnaire (Auto-evaluation of patient satisfaction) ; Timepoint(s) of evaluation of this end point: At J0 (date of first Diprophos injection), J7 and J30. Mini-Dash and Michigan Hand questionnaire: J7 and J30 only.	—

Measure

Time frame

Main Objective: - Assess the effect of corticoids in the acute treatment of the sprain of the proximal interphalangeal joints of the fingers. The future aim is to assess if corticoids can be used as a first choice treatment, instead of a long immobilization or a careful precocious mobilization.;Secondary Objective: Not applicable; Primary end point(s): - Deficit in flexion/extension as measured by the Goniometer ( 40°) - Hyperextension laxity ( 5°) as measured by the Goniometer - Diameter of the proximal interphalangeal joints of the fingers - Prehension force, as measured by the Dynamometer - Pain at the level of the volar plate, as assessed by the EVA pain scale - Mini-DASH questionnaire (Questionnaire of the Disabilities of the Arm, Shoulder and Hand score) - Michigan Hand questionnaire (Auto-evaluation of patient satisfaction) ; Timepoint(s) of evaluation of this end point: At J0 (date of first Diprophos injection), J7 and J30. Mini-Dash and Michigan Hand questionnaire: J7 and J30 only.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactLaura Place

Centre Hospitalier Universitaire Brugmann

laura.place@ulb.ac.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026