Non-invasive Measurement of Compartment Pressure: Reliability
- Conditions
- CEC Syndrome
- Interventions
- Device: Compremium Compressibility MeasurementProcedure: Treadmill RunningOther: Questionnaire
- Registration Number
- NCT05720182
- Lead Sponsor
- Kay van Heeswijk
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- ≥ 18 years
- Proficient in speaking and reading Dutch
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy Volunteers Treadmill Running 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. Healthy Volunteers Questionnaire 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. Healthy Volunteers Compremium Compressibility Measurement 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.
- Primary Outcome Measures
Name Time Method Inter-class correlation 1 session of approximately 90 minutes The primary endpoint of inter-observer variability will be the intraclass correlation coefficient (ICC) of agreement between three observers, four sites per subject, and four repetitions per measurement. The ICC will be assessed using a two-way random effects model. Both observers and subjects will be included as random effects. The first measurement for each location will be taken from every observer to calculate the ICC. Apart from that, the ICC will be measured using the average of the four repetitions of ratings, to estimate the effect on the ICC of repetitive measurements. "Good reliability" classification will be reached if the lower bound of the computed ICC confidence interval does not fall below 0.75.
- Secondary Outcome Measures
Name Time Method Intra-class correlation 1 session of approximately 90 minutes The secondary endpoint of intra-observer variability will be the intraclass correlation coefficient (ICC) of agreement within three observers, four sites per subject, and four repetitions per measurement. The ICC will be assessed using a two-way random effects model. Both subjects and repetitions will be included as random effects. The repeated measures will be analysed for each observer separately and this agreement serves to address differences between observers. "Good reliability" classification will be reached if the lower bound of the computed ICC confidence interval does not fall below 0.75
Exercise effect on compressibility Directly, 1 minute, and 5 minutes post-exercise The second secondary endpoint is the comparison between post-exercise (immediate, one minute, and five minutes) compressibility and rest compressibility. This will be analysed using a dependent sample t-test.
Compressibility is expressed as a CP-value (defined as percentage reduction of the muscle length under two different types of pressure)
Trial Locations
- Locations (1)
Máxima Medisch Centrum
🇳🇱Veldhoven, Noord-Brabant, Netherlands