Non-invasive Measurement of Compartment Pressure: Reliability

November 22, 2024 updated by: Kay van Heeswijk

Validation of CPM#1 Compressibility in Healthy Volunteers in Rest and After Exercise

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Veldhoven, Noord-Brabant, Netherlands, 5500MB
        • Maxima Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Procedure: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-class correlation
Time Frame: 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.
1 session of approximately 90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-class correlation
Time Frame: 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
1 session of approximately 90 minutes
Exercise effect on compressibility
Time Frame: 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)
Directly, 1 minute, and 5 minutes post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kay van Heeswijk

Collaborators

CPM Sport AG Bern

Investigators

  • Principal Investigator: Marc RM Scheltinga, Dr, Maxima Medisch Centrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-MMC-098
  • NL.82601.015.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will only be used by the sponsor and anonymously with the subsiding party.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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