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| ID | Type | Description | Link |
|---|---|---|---|
| NL.82601.015.22 | Other Identifier | CCMO |
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| Name | Class |
|---|---|
| CPM Sport AG Bern | UNKNOWN |
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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:
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.
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-class correlation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc RM Scheltinga, Dr | Máxima Medisch Centrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Máxima Medisch Centrum | Veldhoven | North Brabant | 5500MB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28850498 | Background | 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. | |
| 32019808 | 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. |
| Label | URL |
|---|---|
| Sealed Envelope LTD. Create a blocked randomisation list | View source |
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Data will only be used by the sponsor and anonymously with the subsiding party.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2022 | Jan 18, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 23, 2022 | Jan 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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A performance validation pilot of the CPMX1 device in healthy volunteers. There will only be one study arm, no comparator, and no randomization.
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No true masking possible, as the study only uses healthy participants and all participants will get measurements to both legs.
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| 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. |
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| 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. |
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| 1 session of approximately 90 minutes |
| Exercise effect on compressibility | 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) | Directly, 1 minute, and 5 minutes post-exercise |
| 33731658 | 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. |
| 34931008 | 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. |
| 2301689 | 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. |
| 35288313 | 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. |
| 25756911 | 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. |
| 29195681 | 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. |
| 31205299 | 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. |
| 33640161 | 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. |
| 34963511 | 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. |
| 41878721 | Derived | van Heeswijk K, van Essen B, Kokshoorn A, Schurink GW, Scheltinga M. Pressure-controlled ultrasound is a novel non-invasive technique for detecting anterior chronic exertional compartment syndrome. BMJ Open Sport Exerc Med. 2026 Mar 19;12(1):e003094. doi: 10.1136/bmjsem-2025-003094. eCollection 2026. |
| Winkes MB, Bloo H, Hoogeveen AR, Scheltinga M. Het chronisch inspanningsgebonden compartimentsyndroom van het onderbeen. Physios. 2018;4:9. | View source |
| Meehan WP, O'Brien MJ. Chronic exertional compartment syndrome UpToDate: UpToDate; 2020 | View source |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |