ControlsMAS-ReliabNCT06975202
Test-retest Reliability and Agreement of Trunk Muscle Activation in Pain-free Persons
An observational study of Controls and Healthy Control, run by University Ghent at 1 site in Belgium.
Trial summary
The aim of the study is to investigate test-retest reliability and agreement of trunk muscle activation during functional tasks and clinical sensorimotor control tests in pain-free persons. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Controls, Healthy Control
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Apr 2024to 15 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pain-free persons will be recruited through online advertisement, flyers and posters.
Who may be able to join
- Pain-free persons between 18 and 65 years old
Who cannot join
- Persons experiencing low back pain in the past year
- Patients with serious underlying conditions (e.g., multiple sclerosis)
- Previous spinal surgery
- Persons with any type of blood clotting disorder
- Persons with upper-limb complaints that prevent them from exerting (maximum) force with their arms or hands.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Matheve, Professor contact
Belgium1 site, 1 recruiting
- Recruiting
Faculty of Medicine and Health Sciences
Ghent, 9000
Lieven Danneels, Professor, +32 9 332 26 35, Lieven.danneels@UGent.be
Thomas Matheve, Professor, Thomas.matheve@ugent.be
About this study
The aim of the study is to investigate test-retest reliability and agreement of trunk muscle activation during functional tasks and clinical sensorimotor control tests in pain-free persons.
Read the detailed description
Optimal muscle function is essential for daily life functioning. The current literature suggests that alterations in trunk muscle activation might be one of the contributing factors to the persistence and recurrence of musculoskeletal disorders, including low back pain and lower limb injuries. It is crucial that trunk muscle activation during functional tasks has sufficient reliability and agreement to interpret (longitudinal) studies.
A limited number of studies have investigated the reliability and agreement of trunk muscle activation during dynamic (functional) tasks. Moreover, all these studies used simple discrete outcomes such as mean or peak amplitude. An important limitation is that these single zero-dimensional outcome values ignore the temporal aspects of dynamic tasks. As such, potentially relevant time-specific characteristics of muscle activation might be missed. A comprehensive reliability analysis of curve data (i.e., one-dimensional data) that considers the temporal timeframe is therefore required. An overview of reliability analyses of curve data can be found in Pini et al. This paper concluded that integrated pointwise indices can be recommended. Recently, this innovative analysis was used in biomechanical studies investigating the kinematics and kinetics during jump landing. However, to the best of our knowledge, integrated pointwise indices have not been used to determine reliability and agreement of muscle activation during functional tasks.
The lumbar multifidus has received extensive attention over the past 25 years. The multifidus muscle consists of deep and short fibers that overlay up to 2 segments (i.e., deep multifidus) and more superficial and longer fibers that cross up to 5 segments (i.e., superficial multifidus). As a result of their anatomy, the deep multifidus (DM) predominantly provides segmental stabilization through compressive forces, while the superficial multifidus (SM) mainly generate lumbar movement (i.e., extension, lateral bending, and rotation). Previous studies showed that the distinction between DM and SM activation is especially important for persons with low back pain. Although the results in persons with low back pain vary, the current literature shows a trend towards an overall reduced activation of the DM, while the activation of the SM is often augmented. As such, a clinical test that assesses voluntary DM activation has been proposed and specific motor control therapy that targets the DM has been shown to reduce pain and disability in patients with low back pain. Fine-wire electromyography (EMG) is the only technique that is able to record selective deep muscle activation during dynamic functional tasks, as opposed to other techniques such as surface EMG. However, reliability studies that use fine-wire EMG to measure selective DM and SM activation during functional tasks are currently lacking.
Therefore, this study aims to investigate test-retest reliability and agreement of trunk muscle activation measured with surface and fine-wire EMG during functional tasks in pain-free persons.
- Conditions
- Controls, Healthy Control
- Being tested
- No intervention
- Keywords
- reliability, agreement, muscle activation, functional tasks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Pain-free persons | Pain-free persons Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk muscle onset during the rapid arm movement test
Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.
Measured: Baseline (test-session)
Trunk muscle onset during the rapid arm movement test
Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.
Measured: After a 30-minute break (retest-session)
Secondary outcomes (8)
Trunk muscle (co-)activation
The participant sits on a stool and holds a horizontal bar with both hands, shoulders at 90 degrees (arms are horizontal). The horizontal bar is secured to the ground using a rope and weights. The participant pushes the horizontal bar upwards without moving the arms, pelvis, or spine. The activation of the back and abdominal muscles will be further investigated.
Measured: Baseline (test-session)
Trunk muscle (co-)activation
The participant sits on a stool and holds a horizontal bar with both hands, shoulders at 90 degrees (arms are horizontal). The horizontal bar is secured to the ground using a rope and weights. The participant pushes the horizontal bar upwards without moving the arms, pelvis, or spine. The activation of the back and abdominal muscles will be further investigated.
Measured: After a 30-minute break (retest-session)
Back muscle activation
Back muscle activation will be analyzed during (1) bilateral reaching in standing position, (2) unilateral/bilateral reaching starting in neutral sitting position, and (3) unilateral/bilateral reaching starting in habitual sitting position.
Measured: Baseline (test-session)
Back muscle activation
Back muscle activation will be analyzed during (1) bilateral reaching in standing position, (2) unilateral/bilateral reaching starting in neutral sitting position, and (3) unilateral/bilateral reaching starting in habitual sitting position.
Measured: After a 30-minute break (retest-session)
Voluntary multifidus activation
Voluntary multifidus activation will be measured while the participant lies prone on a treatment table. The participant will be instructed to gently activate the multifidus muscle without movement of the pelvis or spine, while breathing is maintained.
Measured: Baseline (test-session)
Voluntary multifidus activation
Voluntary multifidus activation will be measured while the participant lies prone on a treatment table. The participant will be instructed to gently activate the multifidus muscle without movement of the pelvis or spine, while breathing is maintained.
Measured: After a 30-minute break (retest-session)
Involuntary multifidus activation
Involuntary multifidus activation will be assessed by means of the multifidus lift test (Hebert et al., 2015). The participant is lying in the prone position with the shoulders in 120° abduction and 90° flexion at the elbows. The participant will be asked to lift the entire arm approximately 5 cm from the treatment table. The multifidus activation on the contralateral side will be investigated further.
Measured: Baseline (test-session)
Involuntary multifidus activation
Involuntary multifidus activation will be assessed by means of the multifidus lift test (Hebert et al., 2015). The participant is lying in the prone position with the shoulders in 120° abduction and 90° flexion at the elbows. The participant will be asked to lift the entire arm approximately 5 cm from the treatment table. The multifidus activation on the contralateral side will be investigated further.
Measured: After a 30-minute break (retest-session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start2 Apr 2024
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ControlsStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- VZW Educatieve Lichaamsbeweging
- Responsible party
- Sponsor
- Investigators
- Lieven Danneels, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975202
- Sponsor's protocol ID
- B6702022000426
- Acronym
- MAS-Reliab
- Status last verified
- May 2025
- First submitted
- 20 Sep 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moseley GL, Hodges PW, Gandevia SC. External perturbation of the trunk in standing humans differentially activates components of the medial back muscles. J Physiol. 2003 Mar 1;547(Pt 2):581-7. doi: 10.1113/jphysiol.2002.024950. Epub 2002 Dec 20.
PubMed 12562944MacDonald D, Moseley GL, Hodges PW. People with recurrent low back pain respond differently to trunk loading despite remission from symptoms. Spine (Phila Pa 1976). 2010 Apr 1;35(7):818-24. doi: 10.1097/BRS.0b013e3181bc98f1.
PubMed 20228708Schelin L, Pini A, Markstrom JL, Hager CK. Test-retest reliability of entire time-series data from hip, knee and ankle kinematics and kinetics during one-leg hops for distance: Analyses using integrated pointwise indices. J Biomech. 2021 Jul 19;124:110546. doi: 10.1016/j.jbiomech.2021.110546. Epub 2021 Jun 12.
PubMed 34171677Pini A, Markstrom JL, Schelin L. Test-retest reliability measures for curve data: an overview with recommendations and supplementary code. Sports Biomech. 2022 Feb;21(2):179-200. doi: 10.1080/14763141.2019.1655089. Epub 2019 Oct 3.
PubMed 31578129Wildenbeest MH, Kiers H, Tuijt M, van Dieen JH. Reliability of measures to characterize lumbar movement patterns, in repeated seated reaching, in a mixed group of participants with and without low-back pain: A test-retest, within- and between session. J Biomech. 2021 May 24;121:110435. doi: 10.1016/j.jbiomech.2021.110435. Epub 2021 Apr 15.
PubMed 33894470Matheve T, Hodges P, Danneels L. The Role of Back Muscle Dysfunctions in Chronic Low Back Pain: State-of-the-Art and Clinical Implications. J Clin Med. 2023 Aug 24;12(17):5510. doi: 10.3390/jcm12175510.
PubMed 37685576Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
PubMed 31151377Hebert JJ, Koppenhaver SL, Teyhen DS, Walker BF, Fritz JM. The evaluation of lumbar multifidus muscle function via palpation: reliability and validity of a new clinical test. Spine J. 2015 Jun 1;15(6):1196-202. doi: 10.1016/j.spinee.2013.08.056. Epub 2013 Oct 4.
PubMed 24314767
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability and Agreement of Trunk Muscle Activation in Pain-free Persons
- ClinicalTrials.gov ID
- NCT06975202
- Acronym / sponsor ID
- MAS-Reliab / B6702022000426
- Conditions
- Controls, Healthy Control
- Keywords
- reliability, agreement, muscle activation, functional tasks
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- VZW Educatieve Lichaamsbeweging
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 16 May 2025 (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 aim of the study is to investigate test-retest reliability and agreement of trunk muscle activation during functional tasks and clinical sensorimotor control tests in pain-free persons.
Detailed description
Optimal muscle function is essential for daily life functioning. The current literature suggests that alterations in trunk muscle activation might be one of the contributing factors to the persistence and recurrence of musculoskeletal disorders, including low back pain and lower limb injuries. It is crucial that trunk muscle activation during functional tasks has sufficient reliability and agreement to interpret (longitudinal) studies.
A limited number of studies have investigated the reliability and agreement of trunk muscle activation during dynamic (functional) tasks. Moreover, all these studies used simple discrete outcomes such as mean or peak amplitude. An important limitation is that these single zero-dimensional outcome values ignore the temporal aspects of dynamic tasks. As such, potentially relevant time-specific characteristics of muscle activation might be missed. A comprehensive reliability analysis of curve data (i.e., one-dimensional data) that considers the temporal timeframe is therefore required. An overview of reliability analyses of curve data can be found in Pini et al. This paper concluded that integrated pointwise indices can be recommended. Recently, this innovative analysis was used in biomechanical studies investigating the kinematics and kinetics during jump landing. However, to the best of our knowledge, integrated pointwise indices have not been used to determine reliability and agreement of muscle activation during functional tasks.
The lumbar multifidus has received extensive attention over the past 25 years. The multifidus muscle consists of deep and short fibers that overlay up to 2 segments (i.e., deep multifidus) and more superficial and longer fibers that cross up to 5 segments (i.e., superficial multifidus). As a result of their anatomy, the deep multifidus (DM) predominantly provides segmental stabilization through compressive forces, while the superficial multifidus (SM) mainly generate lumbar movement (i.e., extension, lateral bending, and rotation). Previous studies showed that the distinction between DM and SM activation is especially important for persons with low back pain. Although the results in persons with low back pain vary, the current literature shows a trend towards an overall reduced activation of the DM, while the activation of the SM is often augmented. As such, a clinical test that assesses voluntary DM activation has been proposed and specific motor control therapy that targets the DM has been shown to reduce pain and disability in patients with low back pain. Fine-wire electromyography (EMG) is the only technique that is able to record selective deep muscle activation during dynamic functional tasks, as opposed to other techniques such as surface EMG. However, reliability studies that use fine-wire EMG to measure selective DM and SM activation during functional tasks are currently lacking.
Therefore, this study aims to investigate test-retest reliability and agreement of trunk muscle activation measured with surface and fine-wire EMG during functional tasks in pain-free persons.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain-free persons | – | Other: No interventionPain-free persons |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pain-free persons will be recruited through online advertisement, flyers and posters.
Key inclusion criteria (1 listed)
- Pain-free persons between 18 and 65 years old
Key exclusion criteria (5 listed)
- Persons experiencing low back pain in the past year
- Patients with serious underlying conditions (e.g., multiple sclerosis)
- Previous spinal surgery
- Persons with any type of blood clotting disorder
- Persons with upper-limb complaints that prevent them from exerting (maximum) force with their arms or hands.
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 |
|---|---|---|
| No interventionNo intervention | Other | Pain-free persons |
Primary outcome
Trunk muscle onset during the rapid arm movement test
Time frame: Baseline (test-session)
Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.
Trunk muscle onset during the rapid arm movement test
Time frame: After a 30-minute break (retest-session)
Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.
8 secondary outcomes
Trunk muscle (co-)activation
Time frame: Baseline (test-session)
Trunk muscle (co-)activation
Time frame: After a 30-minute break (retest-session)
Back muscle activation
Time frame: Baseline (test-session)
Back muscle activation
Time frame: After a 30-minute break (retest-session)
Voluntary multifidus activation
Time frame: Baseline (test-session)
Voluntary multifidus activation
Time frame: After a 30-minute break (retest-session)
Involuntary multifidus activation
Time frame: Baseline (test-session)
Involuntary multifidus activation
Time frame: After a 30-minute break (retest-session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 12562944Moseley GL, Hodges PW, Gandevia SC. External perturbation of the trunk in standing humans differentially activates components of the medial back muscles. J Physiol. 2003 Mar 1;547(Pt 2):581-7. doi: 10.1113/jphysiol.2002.024950. Epub 2002 Dec 20.
- Background: PubMed 20228708MacDonald D, Moseley GL, Hodges PW. People with recurrent low back pain respond differently to trunk loading despite remission from symptoms. Spine (Phila Pa 1976). 2010 Apr 1;35(7):818-24. doi: 10.1097/BRS.0b013e3181bc98f1.
- Background: PubMed 34171677Schelin L, Pini A, Markstrom JL, Hager CK. Test-retest reliability of entire time-series data from hip, knee and ankle kinematics and kinetics during one-leg hops for distance: Analyses using integrated pointwise indices. J Biomech. 2021 Jul 19;124:110546. doi: 10.1016/j.jbiomech.2021.110546. Epub 2021 Jun 12.
- Background: PubMed 31578129Pini A, Markstrom JL, Schelin L. Test-retest reliability measures for curve data: an overview with recommendations and supplementary code. Sports Biomech. 2022 Feb;21(2):179-200. doi: 10.1080/14763141.2019.1655089. Epub 2019 Oct 3.
- Background: PubMed 33894470Wildenbeest MH, Kiers H, Tuijt M, van Dieen JH. Reliability of measures to characterize lumbar movement patterns, in repeated seated reaching, in a mixed group of participants with and without low-back pain: A test-retest, within- and between session. J Biomech. 2021 May 24;121:110435. doi: 10.1016/j.jbiomech.2021.110435. Epub 2021 Apr 15.
- Background: PubMed 37685576Matheve T, Hodges P, Danneels L. The Role of Back Muscle Dysfunctions in Chronic Low Back Pain: State-of-the-Art and Clinical Implications. J Clin Med. 2023 Aug 24;12(17):5510. doi: 10.3390/jcm12175510.
- Background: PubMed 31151377Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
- Background: PubMed 24314767Hebert JJ, Koppenhaver SL, Teyhen DS, Walker BF, Fritz JM. The evaluation of lumbar multifidus muscle function via palpation: reliability and validity of a new clinical test. Spine J. 2015 Jun 1;15(6):1196-202. doi: 10.1016/j.spinee.2013.08.056. Epub 2013 Oct 4.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Matheve, Professor contact
Lieven Danneels, Professor principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Controls and Healthy Control, run by University Ghent at 1 site in Belgium.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lieven Danneels, Professor (+32 9 332 26 35, Lieven.danneels@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk muscle onset during the rapid arm movement test (time frame: Baseline (test-session)). The study lists 2 primary outcomes in all. 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 NCT06975202, which also lists 8 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 16 May 2025.