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SprainPhase 2NCT02916940

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

A Phase 2 study testing Diprophos in people with Sprain, run by Brugmann University Hospital at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sprain
What is being tested?
Diprophos
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesBelgium
Study dates
16 Nov 2016to 11 Feb 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • CHU Brugmann

    Brussels, 1020

  • Clinique du Parc Leopold

    Brussels, 1040

Other trials in Belgium

About this study

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).

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.

Conditions
Sprain
Being tested
Diprophos
Keywords
sprains of the proximal interphalangeal joints of the long fingers, Diprophos
Medical subject headings
Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiprophosDrug

    Single subcutaneous injection of Diprophos, in the acute phase.

Study groups in NCT02916940
Study groupRoleWhat they receive
DiprophosExperimentalPatients having had a sprain of the long fingers, within 2 weeks of consultation. This group will receive a single injection of corticoids.
Receives: Drug: Diprophos
Control groupNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flexion/extension deficit

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    Measured: Baseline (day of kenacort injection)

  2. Flexion/extension deficit

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    Measured: 7 days after injection

  3. Flexion/extension deficit

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    Measured: 30 days after injection

  4. Laxity in hyperextension

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    Measured: Baseline (day of kenacort injection)

  5. Laxity in hyperextension

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    Measured: 7 days after injection

  6. Laxity in hyperextension

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer

    Measured: 30 days after injection

  7. Diameter of the articulation

    Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio

    Measured: Baseline (day of kenacort injection)

  8. Diameter of the articulation

    Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio

    Measured: 7 days after injection

  9. Diameter of the articulation

    Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio

    Measured: 30 days after injection

  10. Prehension force

    Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.

    Measured: Baseline (day of kenacort injection)

  11. Prehension force

    Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.

    Measured: 7 days after injection

  12. Prehension force

    Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.

    Measured: 30 days after injection

Secondary outcomes (6)

  1. EVA scale

    Pain assessment at the level of the volar plate

    Measured: 7 days after injection

  2. EVA scale

    Pain assessment at the level of the volar plate

    Measured: 30 days after injection

  3. Mini-DASH

    Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand.

    Measured: 7 days after injection

  4. Mini-DASH

    Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand.

    Measured: 30 days after injection

  5. Mitchigan Hand Questionnaire

    Auto-evaluation of the patient regarding the functionality of his/her articulation

    Measured: 7 days after injection

  6. Mitchigan Hand Questionnaire

    Auto-evaluation of the patient regarding the functionality of his/her articulation

    Measured: 30 days after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study start16 Nov 2016
  3. Primary completion11 Feb 2020
  4. Study completion11 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02916940
Sponsor's protocol ID
CHUB-Diprophos-IPP
Status last verified
Aug 2020
First submitted
26 Sep 2016
Last updated
6 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Freiberg A, Pollard BA, Macdonald MR, Duncan MJ. Management of proximal interphalangeal joint injuries. J Trauma. 1999 Mar;46(3):523-8. doi: 10.1097/00005373-199903000-00033. No abstract available.

    PubMed 10088864

  • 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;2013(2):CD009030. doi: 10.1002/14651858.CD009030.pub2.

    PubMed 23450596

  • 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.

    PubMed 24503231

  • 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.

    PubMed 26143967

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diprophos in people with Sprain, run by Brugmann University Hospital at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flexion/extension deficit (time frame: Baseline (day of kenacort injection)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02916940, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.

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