Non-invasive Measurement of Compartment Pressure: Reliability

Kay van Heeswijk

Status: Completed

Conditions: CEC Syndrome

Treatments: Other: Questionnaire; Procedure: Treadmill Running; Device: Compremium Compressibility Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05720182

2022-MMC-098

NL.82601.015.22 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

Healthy subjects are not subjected to any type of treatment besides non-invasive lower leg muscle compressibility measurements in rest and after exercise. All 35 healthy subjects will undergo four times four measurements in rest (m. tibialis anterior of both legs, using two different internal landmarks). These four times four measurements in rest will each be done by three observers. To measure the effect of exercise, compressibility will be measured immediately, one minute, and five minutes after a standard treadmill exercise at just one leg. The treadmill exercise and the corresponding measurements will be performed twice to address for measurements of both legs.

Treatment:

Device: Compremium Compressibility Measurement

Procedure: Treadmill Running

Other: Questionnaire