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

August 5, 2020 updated by: Socorro ORTIZ, Brugmann University Hospital

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium, 1020
        • CHU Brugmann
      • Brussels, Belgium, 1040
        • Clinique du Parc Leopold

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Single subcutaneous injection of Diprophos, in the acute phase.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EVA scale
Time Frame: 7 days after injection
Pain assessment at the level of the volar plate
7 days after injection
EVA scale
Time Frame: 30 days after injection
Pain assessment at the level of the volar plate
30 days after injection
Mini-DASH
Time Frame: 7 days after injection
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
Time Frame: 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.
30 days after injection
Mitchigan Hand Questionnaire
Time Frame: 7 days after injection
Auto-evaluation of the patient regarding the functionality of his/her articulation
7 days after injection
Mitchigan Hand Questionnaire
Time Frame: 30 days after injection
Auto-evaluation of the patient regarding the functionality of his/her articulation
30 days after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Nader Chahidi, MD, Clinique du Parc Leopold

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2016

Primary Completion (Actual)

February 11, 2020

Study Completion (Actual)

February 11, 2020

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sprain

Clinical Trials on Diprophos

3
Subscribe