Non-invasive Measurement of Compartment Pressure: Reliability

NCT05720182 | Completed DMC

• 2 other identifiers: 2022-MMC-098NL.82601.015.22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

CEC Syndrome

Keywords

Non-invasive; Reliability; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Inter-class correlation

  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.

  1 session of approximately 90 minutes

Secondary Outcomes (2)

• Intra-class correlation

  1 session of approximately 90 minutes

• Exercise effect on compressibility

  Directly, 1 minute, and 5 minutes post-exercise

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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.

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

Interventions

Compremium Compressibility Measurement DEVICE

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.

Healthy Volunteers

Treadmill Running PROCEDURE

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.

Healthy Volunteers

Questionnaire OTHER

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.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• Proficient in speaking and reading Dutch

You may not qualify if:

• 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

Sponsors & Collaborators

• Kay van Heeswijk: lead
• CPM Sport AG Bern: collaborator

Study Sites (1)

Máxima Medisch Centrum

Veldhoven, North Brabant, 5500MB, Netherlands

Location

Related Publications (11)

• 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.

  PMID: 28850498 BACKGROUND

• 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.

  PMID: 32019808 BACKGROUND

• 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.

  PMID: 33731658 BACKGROUND

• 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.

  PMID: 34931008 BACKGROUND

• 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.

  PMID: 2301689 BACKGROUND

• 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.

  PMID: 35288313 BACKGROUND

• 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.

  PMID: 25756911 BACKGROUND

• 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.

  PMID: 29195681 BACKGROUND

• 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.

  PMID: 31205299 BACKGROUND

• 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.

  PMID: 33640161 BACKGROUND

• 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.

  PMID: 34963511 BACKGROUND

Related Links

• 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

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marc RM Scheltinga, Dr

  Máxima Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No true masking possible, as the study only uses healthy participants and all participants will get measurements to both legs.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Model Details: A performance validation pilot of the CPMX1 device in healthy volunteers. There will only be one study arm, no comparator, and no randomization.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 9, 2023
• Study Start: January 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)