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Trial record 24 of 345 for:    sprains and strains

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

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ClinicalTrials.gov Identifier: NCT02916940
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Socorro ORTIZ, 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.


Condition or disease Intervention/treatment Phase
Sprain Drug: Diprophos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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).
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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.
Drug: Diprophos
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916940


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
Clinique du Parc Leopold
Brussels, Belgium, 1040
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Study Director: Nader Chahidi, MD Clinique du Parc Léopold

Publications:
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Responsible Party: Socorro ORTIZ, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02916940     History of Changes
Other Study ID Numbers: CHUB-Diprophos-IPP
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Socorro ORTIZ, Brugmann University Hospital:
sprains of the proximal interphalangeal joints of the long fingers
Diprophos

Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries
Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Betamethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents