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).
Verified date | August 2020 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann | Brussels | |
Belgium | Clinique du Parc Leopold | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital |
Belgium,
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
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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