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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02916940
Other study ID # CHUB-Diprophos-IPP
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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