Trials / Completed
CompletedNCT03840434
COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure
COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University Hospital, Angers · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed. Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS. Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.
Detailed description
Patients referred for suspected chronic compartment syndrome causing will be included. After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | MyotonPRO | Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO |
Timeline
- Start date
- 2019-06-19
- Primary completion
- 2023-03-27
- Completion
- 2023-03-27
- First posted
- 2019-02-15
- Last updated
- 2023-04-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03840434. Inclusion in this directory is not an endorsement.