Clinical trial NCT05720182: Non-invasive Measurement of Compartment Pressure: Reliability
Official title: Validation of CPM#1 Compressibility in Healthy Volunteers in Rest and After Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CEC Syndrome
Keywords: Non-invasive
Reliability
Healthy Volunteers
Lead sponsor: Maxima Medical Center
Sponsor class: OTHER
Collaborators: name: CPM Sport AG Bern
First posted: 2023-02-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A performance validation pilot of the CPMX1 device in healthy volunteers. There will only be one study arm, no comparator, and no randomization.
Primary purpose: OTHER

Brief summary: The investigators want to investigate the reliability (variability) of a new device, that should be able to measure lower leg compartment pressure non-invasively. Therefore the tool is used under different circumstances. The introduced differences in circumstances are:

* Measurements at several time points
* Measurements using different anatomical landmarks
* Measurements by different researchers
* Measurements in rest and after exercise

This study's results are important to create a reliable measurement tools for patients with lower leg symptoms. In this way the diagnosis can be improved and as well the treatments given to the patients.

It is expected that the variability of the device will be low compared to current techniques.

Detailed description: Chronic Exertional Compartment Syndrome (CECS) is one of the exercise-induced lower leg pathologies. Recognition by patients and physicians is not optimal. As a consequence, many patients are undiagnosed and are forced to stop their sporting activities. To diagnose CECS, a doctor should be alerted by a patient's history and a physical examination. If both suggestive of CECS, an invasive intra compartmental pressure measurement (ICPM) in the affected compartment may be performed. During the ICPM a catheter is placed into the muscle via a hollow needle. The ICPM is not flawless in terms of accuracy and reproducibility and has a low intra-observer reproducibility. Moreover, haematoma or other tissue damage may occur following an ICPM. Nevertheless, this invasive ICPM is in 2022 still considered the 'gold-standard' diagnostic tool for CECS, in the absence of a better one.

A novel non-invasive tool for CECS is possibly provided by measuring muscle tissue compressibility. The idea is, that muscle tissue with a high pressure (as in CECS patients) requires more external force to compress, compared to tissue with a low pressure. The study device used in this study, the CPM#1 device, is based on this principle. The CPM#1 device is non-invasive, not painful, very user friendly, and the measurement can be executed as an 'office procedure' in a couple of minutes. This study will focus on determining the reliability of the device in healthy volunteers.

The primary objective is

- To validate the inter-observer reliability of compressibility measurements with the CPM#1 device during rest in healthy volunteers.

Secondary objectives are

* To validate the intra-observer reliability of compressibility measurements with the CPM#1 device during rest in healthy volunteers.
* To investigate the effect of exercise on compressibility immediately, one minute, and five minutes after exercise in healthy volunteers.
* To map the invasiveness of the compressibility measurement with the CPM#1 device.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Healthy subjects will undergo several compressibility measurements, both before and after a treadmill exercise. They will also complete a NIAPS (Netwerk Inspannings Afhankelijke PijnSyndromen) questionnaire and an 'experience' questionnaire. The harm associated with the CPM#1 device is none. However, the subjects will not benefit from this study

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* Proficient in speaking and reading Dutch

Exclusion Criteria:

* Presence of complaints suggestive of CECS, previously diagnosed with CECS or previous positive ICPM
* History of surgery or other trauma which penetrated the fascia of the leg
* Other concurrent limb pathologies or anomalies amongst others:
* Peripheral arterial or venous disease
* Muscle disorders, diabetes mellitus, peripheral neuropathies
* Unable to exercise for five minutes
* Open wound or painful bruise less than one week ago at site of measurement

Primary outcomes:
measure: Inter-class correlation
timeFrame: 1 session of approximately 90 minutes
Secondary outcomes:
measure: Intra-class correlation
timeFrame: 1 session of approximately 90 minutes
measure: Exercise effect on compressibility
timeFrame: Directly, 1 minute, and 5 minutes post-exercise
Other outcomes:
Locations:
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
state: Noord-Brabant
Study officials:
affiliation: Máxima Medisch Centrum
name: Marc RM Scheltinga, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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