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Completed

NCT Number: NCT02916940

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

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.

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Key information

Conditions

Sprain Sprains and Strains Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Brugmann, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diprophos

Drug

Single subcutaneous injection of Diprophos, in the acute phase.

Primary outcomes

  1. Flexion/extension deficit

    Time frame: Baseline (day of kenacort injection)

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

  2. Flexion/extension deficit

    Time frame: 7 days after injection

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

  3. Flexion/extension deficit

    Time frame: 30 days after injection

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

  4. Laxity in hyperextension

    Time frame: Baseline (day of kenacort injection)

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

  5. Laxity in hyperextension

    Time frame: 7 days after injection

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

  6. Laxity in hyperextension

    Time frame: 30 days after injection

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.

Secondary outcomes

  1. EVA scale

    Time frame: 7 days after injection

    Pain assessment at the level of the volar plate

  2. EVA scale

    Time frame: 30 days after injection

    Pain assessment at the level of the volar plate

  3. 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.

  4. 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.

  5. Mitchigan Hand Questionnaire

    Time frame: 7 days after injection

    Auto-evaluation of the patient regarding the functionality of his/her articulation

  6. Mitchigan Hand Questionnaire

    Time frame: 30 days after injection

    Auto-evaluation of the patient regarding the functionality of his/her articulation

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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).

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2016
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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