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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02916940
• Date of registration: 26/09/2016
• Prospective Registration: Yes
• Primary sponsor: Brugmann University Hospital
• Public title: Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.
• Scientific 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).
• Date of first enrolment: November 16, 2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02916940
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Nader Chahidi, MD
• Affiliation: Clinique du Parc Léopold

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sprain

Intervention(s)

Drug: Diprophos

Primary Outcome(s)

Flexion/extension deficit [Time Frame: Baseline (day of kenacort injection)]

Flexion/extension deficit [Time Frame: 30 days after injection]

Diameter of the articulation [Time Frame: 7 days after injection]

Laxity in hyperextension [Time Frame: 30 days after injection]

Laxity in hyperextension [Time Frame: Baseline (day of kenacort injection)]

Diameter of the articulation [Time Frame: Baseline (day of kenacort injection)]

Flexion/extension deficit [Time Frame: 7 days after injection]

Diameter of the articulation [Time Frame: 30 days after injection]

Laxity in hyperextension [Time Frame: 7 days after injection]

Prehension force [Time Frame: 7 days after injection]

Prehension force [Time Frame: Baseline (day of kenacort injection)]

Prehension force [Time Frame: 30 days after injection]

Secondary Outcome(s)

Mini-DASH [Time Frame: 7 days after injection]

Mitchigan Hand Questionnaire [Time Frame: 30 days after injection]

EVA scale [Time Frame: 7 days after injection]

Mini-DASH [Time Frame: 30 days after injection]

Mitchigan Hand Questionnaire [Time Frame: 7 days after injection]

EVA scale [Time Frame: 30 days after injection]

Secondary ID(s)

CHUB-Diprophos-IPP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors