CEC SyndromeNCT05720182
Non-invasive Measurement of Compartment Pressure: Reliability
A study testing Compremium Compressibility Measurement, Treadmill Running and Questionnaire in people with CEC Syndrome, run by Kay van Heeswijk at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CEC Syndrome
- What is being tested?
- Compremium Compressibility Measurement, Treadmill Running and Questionnaire
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Proficient in speaking and reading Dutch
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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.
Read the 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
- Conditions
- CEC Syndrome
- Being tested
- Compremium Compressibility Measurement, Treadmill Running, Questionnaire
- Keywords
- Non-invasive, Reliability, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compremium Compressibility MeasurementDevice
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 RunningProcedure or surgery
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.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Compremium Compressibility Measurement; Procedure: Treadmill Running; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 session of approximately 90 minutes
Secondary outcomes (2)
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
Measured: 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)
Measured: Directly, 1 minute, and 5 minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start15 Jan 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for CEC SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A performance validation pilot of the CPMX1 device in healthy volunteers. There will only be one study arm, no comparator, and no randomization.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kay van Heeswijk
- Sponsor type
- University, hospital or other
- Collaborators
- CPM Sport AG Bern
- Responsible party
- Sponsor-investigator, Kay van Heeswijk, Maxima Medical Center
- Investigators
- Marc RM Scheltinga, Dr, Principal investigator, Máxima Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720182
- Sponsor's protocol ID
- 2022-MMC-098
- Other IDs
- NL.82601.015.22
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be used by the sponsor and anonymously with the subsiding party.
Publications
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.
PubMed 28850498Maksymiak 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.
PubMed 32019808Vogels 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.
PubMed 33731658Houston 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.
PubMed 34931008Pedowitz 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.
PubMed 2301689Vogels 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.
PubMed 35288313Large 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.
PubMed 25756911Bloch 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.
PubMed 29195681Herring 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.
PubMed 31205299Marmor 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.
PubMed 33640161Anwander 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.
PubMed 34963511van 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.
PubMed 41878721
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of CPM#1 Compressibility in Healthy Volunteers in Rest and After Exercise
- ClinicalTrials.gov ID
- NCT05720182
- Acronym / sponsor ID
- 2022-MMC-098
- Conditions
- CEC Syndrome
- Keywords
- Non-invasive, Reliability, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kay van HeeswijkUniversity, hospital or other
- Collaborators
- CPM Sport AG Bern
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A performance validation pilot of the CPMX1 device in healthy volunteers. There will only be one study arm, no comparator, and no randomization.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: Compremium Compressibility Measurement, Procedure: Treadmill Running, Other: QuestionnaireHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years
- Proficient in speaking and reading Dutch
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compremium Compressibility MeasurementCPM#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. | Device | Healthy Volunteers |
| Treadmill RunningExercise: 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. | Procedure or surgery | Healthy Volunteers |
| QuestionnaireQuestionnaires 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. | Other | Healthy Volunteers |
Primary outcome
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.
2 secondary outcomes
Intra-class correlation
Time frame: 1 session of approximately 90 minutes
Exercise effect on compressibility
Time frame: Directly, 1 minute, and 5 minutes post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 28850498Orlin 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.
- Background: PubMed 32019808Maksymiak 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.
- Background: PubMed 33731658Vogels 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.
- Background: PubMed 34931008Houston 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.
- Background: PubMed 2301689Pedowitz 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.
- Background: PubMed 35288313Vogels 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.
- Background: PubMed 25756911Large 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.
- Background: PubMed 29195681Bloch 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.
- Background: PubMed 31205299Herring 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.
- Background: PubMed 33640161Marmor 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.
- Background: PubMed 34963511Anwander 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.
- Derived from this study: PubMed 41878721van 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.
- Sealed Envelope LTD. Create a blocked randomisation listLink provided by the sponsor.
- Winkes MB, Bloo H, Hoogeveen AR, Scheltinga M. Het chronisch inspanningsgebonden compartimentsyndroom van het onderbeen. Physios. 2018;4:9.Link provided by the sponsor.
- Meehan WP, O'Brien MJ. Chronic exertional compartment syndrome UpToDate: UpToDate; 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data will only be used by the sponsor and anonymously with the subsiding party.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc RM Scheltinga, Dr principal investigator
Máxima Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compremium Compressibility Measurement, Treadmill Running and Questionnaire in people with CEC Syndrome, run by Kay van Heeswijk at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-class correlation (time frame: 1 session of approximately 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05720182, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.