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

Sprain Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916940
• Other study ID #: CHUB-Diprophos-IPP
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2016
• Est. completion date: February 11, 2020

Study information

• Verified date: August 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sprain
• Sprains and Strains

Intervention

Drug:
• Diprophos
Single subcutaneous injection of Diprophos, in the acute phase.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels
Belgium	Clinique du Parc Leopold	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Chalmer J, Blakeway M, Adams Z, Milan SJ. Conservative interventions for treating hyperextension injuries of the proximal interphalangeal joints of the fingers. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD009030. doi: 10.1002/14651858.CD009030.pub2. Review. — View Citation

Freiberg A, Pollard BA, Macdonald MR, Duncan MJ. Management of proximal interphalangeal joint injuries. J Trauma. 1999 Mar;46(3):523-8. Review. — View Citation

Micev AJ, Saucedo JM, Kalainov DM, Wang L, Ma M, Yaffe MA. Surgical Techniques for Correction of Traumatic Hyperextension Instability of the Proximal Interphalangeal Joint: A Biomechanical Study. J Hand Surg Am. 2015 Aug;40(8):1631-7. doi: 10.1016/j.jhsa.2015.05.011. Epub 2015 Jul 3. — View Citation

Paschos NK, Abuhemoud K, Gantsos A, Mitsionis GI, Georgoulis AD. Management of proximal interphalangeal joint hyperextension injuries: a randomized controlled trial. J Hand Surg Am. 2014 Mar;39(3):449-54. doi: 10.1016/j.jhsa.2013.11.038. Epub 2014 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flexion/extension deficit	Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.	Baseline (day of kenacort injection)
Primary	Flexion/extension deficit	Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.	7 days after injection
Primary	Flexion/extension deficit	Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.	30 days after injection
Primary	Laxity in hyperextension	Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.	Baseline (day of kenacort injection)
Primary	Laxity in hyperextension	Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.	7 days after injection
Primary	Laxity in hyperextension	Evaluation of the maximal amplitude of the articulation, as measured by a goniometer	30 days after injection
Primary	Diameter of the articulation	Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio	Baseline (day of kenacort injection)
Primary	Diameter of the articulation	Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio	7 days after injection
Primary	Diameter of the articulation	Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio	30 days after injection
Primary	Prehension force	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)
Primary	Prehension force	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
Primary	Prehension force	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	EVA scale	Pain assessment at the level of the volar plate	7 days after injection
Secondary	EVA scale	Pain assessment at the level of the volar plate	30 days after injection
Secondary	Mini-DASH	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
Secondary	Mini-DASH	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
Secondary	Mitchigan Hand Questionnaire	Auto-evaluation of the patient regarding the functionality of his/her articulation	7 days after injection
Secondary	Mitchigan Hand Questionnaire	Auto-evaluation of the patient regarding the functionality of his/her articulation	30 days after injection