Non-invasive Measurement of Compartment Pressure: Reliability
NCT ID: NCT05720182
Last Updated: 2024-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2023-01-15
2024-02-15
Brief Summary
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* 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.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Healthy Volunteers
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.
Compremium Compressibility Measurement
CPM#1 measurements:
Step 1: Manual investigation to identify the compartment for compressibility measurements
Step 2: Marking the location for compressibility measurements
Step 3 - Examination with CPM#1
* Place the probe on the target area
* Identify correct landmark
* Compress the compartment
* Increase steadily the pressure applied by the CP probe to 80 mmHg.
Treadmill Running
Exercise:
Step 1: Participants will walk on a treadmill with standardized walking speed (5.0 km/hour) and slope (15%) for 5 minutes.
Step 2: Immediate, one minute, and five minutes post-exercise CPM#1 measurements will be performed at one leg.
Exercise and post-exercise CPM#1 measurements will be repeated for the other leg.
Questionnaire
Questionnaires NIAPS questionnaire: Baseline NIAPS questionnaire with one additional question about leg dominance.
Experience questionnaire: Scores 1-5, questioning the intensity, how painful, the nuisance, the duration of the study and the non-invasive pressure measurements.
Interventions
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Compremium Compressibility Measurement
CPM#1 measurements:
Step 1: Manual investigation to identify the compartment for compressibility measurements
Step 2: Marking the location for compressibility measurements
Step 3 - Examination with CPM#1
* Place the probe on the target area
* Identify correct landmark
* Compress the compartment
* Increase steadily the pressure applied by the CP probe to 80 mmHg.
Treadmill Running
Exercise:
Step 1: Participants will walk on a treadmill with standardized walking speed (5.0 km/hour) and slope (15%) for 5 minutes.
Step 2: Immediate, one minute, and five minutes post-exercise CPM#1 measurements will be performed at one leg.
Exercise and post-exercise CPM#1 measurements will be repeated for the other leg.
Questionnaire
Questionnaires NIAPS questionnaire: Baseline NIAPS questionnaire with one additional question about leg dominance.
Experience questionnaire: Scores 1-5, questioning the intensity, how painful, the nuisance, the duration of the study and the non-invasive pressure measurements.
Eligibility Criteria
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Inclusion Criteria
* Proficient in speaking and reading Dutch
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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CPM Sport AG Bern
UNKNOWN
Kay van Heeswijk
OTHER
Responsible Party
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Kay van Heeswijk
Coordinating Investigator
Principal Investigators
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Marc RM Scheltinga, Dr
Role: PRINCIPAL_INVESTIGATOR
Máxima Medisch Centrum
Locations
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Máxima Medisch Centrum
Veldhoven, North Brabant, Netherlands
Countries
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References
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Orlin JR, Lied IH, Stranden E, Irgens HU, Andersen JR. Prevalence of chronic compartment syndrome of the legs: Implications for clinical diagnostic criteria and therapy. Scand J Pain. 2016 Jul;12:7-12. doi: 10.1016/j.sjpain.2016.01.001. Epub 2016 Mar 4.
Maksymiak R, Ritchie E, Zimmermann W, Maliko N, van der Werve M, Verschure M, Hoencamp R. Historic cohort: outcome of chronic exertional compartment syndrome-suspected patients. BMJ Mil Health. 2021 Dec;167(6):387-392. doi: 10.1136/jramc-2019-001290. Epub 2020 Feb 3.
Vogels S, VAN Ark W, Janssen L, Scheltinga MRM. Fasciectomy for Recurrent Chronic Exertional Compartment Syndrome of the Anterior Leg. Med Sci Sports Exerc. 2021 Aug 1;53(8):1549-1554. doi: 10.1249/MSS.0000000000002631.
Houston A, Cosma G, Turner P, Bennett A. Predicting surgical outcomes for chronic exertional compartment syndrome using a machine learning framework with embedded trust by interrogation strategies. Sci Rep. 2021 Dec 20;11(1):24281. doi: 10.1038/s41598-021-03825-4.
Pedowitz RA, Hargens AR, Mubarak SJ, Gershuni DH. Modified criteria for the objective diagnosis of chronic compartment syndrome of the leg. Am J Sports Med. 1990 Jan-Feb;18(1):35-40. doi: 10.1177/036354659001800106.
Vogels S, Ritchie ED, Bakker EWP, Vogels MAJM, Zimmermann WO, Verhofstad MHJ, Hoencamp R. Measuring intracompartmental pressures for the chronic exertional compartment syndrome: Challenging commercially available devices and their respective accuracy. J Biomech. 2022 Apr;135:111026. doi: 10.1016/j.jbiomech.2022.111026. Epub 2022 Feb 28.
Large TM, Agel J, Holtzman DJ, Benirschke SK, Krieg JC. Interobserver Variability in the Measurement of Lower Leg Compartment Pressures. J Orthop Trauma. 2015 Jul;29(7):316-21. doi: 10.1097/BOT.0000000000000317.
Bloch A, Tomaschett C, Jakob SM, Schwinghammer A, Schmid T. Compression sonography for non-invasive measurement of lower leg compartment pressure in an animal model. Injury. 2018 Mar;49(3):532-537. doi: 10.1016/j.injury.2017.11.036. Epub 2017 Nov 27.
Herring MJ, Donohoe E, Marmor MT. A Novel Non-invasive Method for the Detection of Elevated Intra-compartmental Pressures of the Leg. J Vis Exp. 2019 May 31;(147). doi: 10.3791/59887.
Marmor MT, Barker JP, Matz J, Donohoe E, Herring MJ. A dual-sensor ultrasound based method for detecting elevated muscle compartment pressures: A prospective clinical pilot study. Injury. 2021 Aug;52(8):2166-2172. doi: 10.1016/j.injury.2021.02.054. Epub 2021 Feb 19.
Anwander H, Buchel L, Krause F, Siebenrock K, Schmid T. Tibial anterior compartment compressibility in healthy subject, measured using compression sonography. Injury. 2022 Feb;53(2):719-723. doi: 10.1016/j.injury.2021.12.014. Epub 2021 Dec 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Sealed Envelope LTD. Create a blocked randomisation list
Winkes MB, Bloo H, Hoogeveen AR, Scheltinga M. Het chronisch inspanningsgebonden compartimentsyndroom van het onderbeen. Physios. 2018;4:9.
Meehan WP, O'Brien MJ. Chronic exertional compartment syndrome UpToDate: UpToDate; 2020
Other Identifiers
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NL.82601.015.22
Identifier Type: OTHER
Identifier Source: secondary_id
2022-MMC-098
Identifier Type: -
Identifier Source: org_study_id
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