Recurrent Low Back PainMASNCT06452030
Changing Trunk Muscle Activation in Patients With Recurrent Low Back Pain in Remission
A study testing Aspecific extension training and Fascia training in people with Recurrent Low Back Pain and Remission, run by University Ghent at 1 site in Belgium.
Trial summary
The first aim of the study is to investigate the effects of a single therapy session on trunk muscle activation and lumbopelvic sensorimotor control in persons with recurrent low back pain in remission. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Low Back Pain, Remission
- What is being tested?
- Aspecific extension training and Fascia training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Mar 2024to 1 Oct 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People between 18-65 years old
- Having recurrent non-specific low back pain (LBP) in remission at enrolment:
- At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP
- Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10
- During remission the NRS intensity for LBP should be 0-1/10.
- Having a dominant flexion movement pattern/ neutral movement pattern
Who cannot join
- People <18 years old or >65 years old
- Having any other type of non-specific LBP (acute, subacute, chronic).
- Having an active extension movement pattern
- Having any type of blood clotting disorder
- People with upper-limb complaints that prevent them from exerting (maximum) force with their arms or hands.
- People that received specific sensorimotor control training or fascia-training in the previous year
Show all 9Show fewer
- People with serious underlying conditions (e.g., multiple sclerosis) or severe scoliosis
- People with a history of spine surgery
- Pregnant women and women who have given birth in the year before enrolment
Trial locations and contacts
1 site in 1 country.
Thomas Matheve, Prof contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, 9000
Lieven Danneels, Prof, +32 9 332 26 35, lieven.danneels@ugent.be
Thomas Matheve, Prof, thomas.matheve@ugent.be
About this study
The first aim of the study is to investigate the effects of a single therapy session on trunk muscle activation and lumbopelvic sensorimotor control in persons with recurrent low back pain in remission.
The second aim of the study is to examine the convergent validity of (in)voluntary multifidus activation by means of inspection and palpation during two clinically assessed lumbopelvic sensorimotor control tests in persons with recurrent low back pain in remission. The convergent validity will be examined by calculating the relationship between (1) the clinical score of (in)voluntary multifidus activation, (2) back muscle activation during the same tests measured simultaneously with electromyography and (3) trunk muscle activation during other functional movements measured with electromyography.
The third aim of the study is to investigate the convergent validity of a left-right discrimination test by calculating the relationship between (1) the left-right discrimination test, (2) position-reposition test, (3) the Fremantle Back Awareness Questionnaire and (4) the Photograph Series of Daily Activities Scale.
Read the detailed description
Low back pain (LBP) is a very common musculoskeletal disorder. Previous research has already demonstrated that trunk muscle function and sensorimotor control (SMC) are altered in people with LBP, which may be an important underlying mechanism contributing to their pain. While there is some evidence regarding the immediate effects of exercise therapy on back muscle function (i.e., earlier onset of activity after one therapy session), the effects of a single therapy session on functional movements and clinically assessed SMC tests in patients with recurrent LBP in remission have never been investigated.
Inspection and palpation are often used in clinical settings to detect lumbopelvic SMC changes in people with LBP. If lumbopelvic SMC changes are noted during the clinical examination, specific SMC therapy can be implemented into the treatment plan. Thus, it is critical that the clinically assessed lumbopelvic SMC tests are sufficiently valid. An important prerequisite is that the clinically assessed SMC parameter is related to objectively measured SMC parameters during the same test. However, clinically assessed lumbopelvic SMC tests are often performed in standardized and less functional positions (e.g., prone lying). As such, the question arises whether results from clinically assessed SMC tests are associated with objective SMC parameters evaluated during functional activities relevant for the individual patient (e.g., lifting). Our systematic review showed that only one clinically assessed lumbopelvic SMC test had sufficient convergent validity with low quality of evidence (Brandt et al., 2024). Moreover, no studies investigated the relationships between clinically assessed lumbopelvic SMC tests and objectively measured SMC parameters during a functional task. Further high-quality studies are therefore needed.
In addition, the left-right discrimination test is also accessible in clinical settings. The left-right discrimination test assesses a person's body perception. During this test, the participant must view images on a computer of a person with the trunk flexed or rotated to the left or right. The participant must indicate as quickly and accurately as possible which side of the trunk of the person in the image is bent or turned. Another way to assess body perception is by using the Fremantle Back Awareness Questionnaire, of which the Dutch version was recently validated. It has been suggested that body perception is the result of the interaction of internal "body maps," sensory information, motor output, and beliefs and perceptions about the body. However, the relationship between the left-right discrimination test, the position-reposition test, and the Fremantle Back Awareness Questionnaire has not yet been explored.
- Conditions
- Recurrent Low Back Pain, Remission
- Being tested
- Specific sensorimotor control training, Aspecific extension training, Fascia training
- Keywords
- Low back pain, Motor control, Exercise, Randomised Controlled Trial
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific sensorimotor control trainingBehavioural
Participants allocated to the specific motor control group will receive sensorimotor training of the multifidus muscle.
Aspecific extension trainingBehavioural
Participants allocated to the aspecific group will receive spinal extension exercises.
Fascia trainingBehavioural
Participants allocated to the fascia group will receive general movement exercises.
| Study group | Role | What they receive |
|---|---|---|
| Specific sensorimotor control training | Experimental | One low-load treatment session of selective multifidus activation. Receives: Behavioral: Specific sensorimotor control training |
| Aspecific extension training | Active comparator | One low-load treatment session of back muscle activation. Receives: Behavioral: Aspecific extension training |
| Fascia training | Experimental | One low-load treatment session of general movement exercises. Receives: Behavioral: Fascia training |
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
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: Immediately after therapy
Secondary outcomes (14)
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
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: Immediately after therapy
Back muscle activation
Back muscle activation will be analyzed during (1) bilateral reaching in standing position, (2) bilateral reaching starting in neutral sitting position, and (3) bilateral reaching starting in habitual sitting position.
Measured: Baseline
Back muscle activation
Back muscle activation will be analyzed during (1) bilateral reaching in standing position, (2) bilateral reaching starting in neutral sitting position, and (3) bilateral reaching starting in habitual sitting position.
Measured: Immediately after therapy
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
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: Immediately after therapy
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
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: Immediately after therapy
Lumbar proprioception
Lumbar proprioception will be evaluated by means of the position-reposition test. First, the spine of the participant spine is placed in a reference position (50% of maximum range of motion). Second, the participant is asked to return to a neutral sitting position and then to resume the reference position (50% of maximum range of motion). The difference between the two positions will be further investigated.
Measured: Baseline
Left-right discrimination test
During the left-right discrimination test, the participants are required to view images on a tablet of a person whose trunk is bent or rotated to the left or right. The participant must press 'left' or 'right' as quickly and accurately as possible to indicate which side the person's trunk on the image is bent or rotated. The accuracy and speed will be further analyzed.
Measured: Baseline
Disability (questionnaire)
The Roland Morris Disability Questionnaire will be used to evaluate disability.
Measured: Baseline
Body perception (questionnaire)
The Fremantle Back Awareness Questionnaire will be used to evaluate body perception.
Measured: Baseline
Kinesiophobia
The Tampa Scale for Kinesiophobia will be used to evaluate kinesiophobia.
Measured: Baseline
Perceived harmfulness
The Photograph Series of Daily Activities will be used to evaluate perceived harmfulness.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start29 Mar 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Recurrent Low Back PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study model is parallel. Participants with recurrent low back pain in remission will be randomly allocated to receive either (1) specific sensorimotor control training, (2) general extension training or (3) fascia therapy (i.e. parallel study model).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 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, Prof, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452030
- Sponsor's protocol ID
- ONZ-2022-0310
- Acronym
- MAS
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Vet HC, Heymans MW, Dunn KM, Pope DP, van der Beek AJ, Macfarlane GJ, Bouter LM, Croft PR. Episodes of low back pain: a proposal for uniform definitions to be used in research. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2409-16. doi: 10.1097/01.BRS.0000030307.34002.BE.
PubMed 12438991Stanton TR, Latimer J, Maher CG, Hancock MJ. A modified Delphi approach to standardize low back pain recurrence terminology. Eur Spine J. 2011 May;20(5):744-52. doi: 10.1007/s00586-010-1671-8. Epub 2010 Dec 31.
PubMed 21193932Tsao H, Hodges PW. Immediate changes in feedforward postural adjustments following voluntary motor training. Exp Brain Res. 2007 Aug;181(4):537-46. doi: 10.1007/s00221-007-0950-z. Epub 2007 May 3.
PubMed 17476489Tsao H, Druitt TR, Schollum TM, Hodges PW. Motor training of the lumbar paraspinal muscles induces immediate changes in motor coordination in patients with recurrent low back pain. J Pain. 2010 Nov;11(11):1120-8. doi: 10.1016/j.jpain.2010.02.004.
PubMed 20434958Matheve 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 24314767Meier R, Iten P, Luomajoki H. Clinical assessments can discriminate altered body perception in patients with unilateral chronic low back pain, but not differences between affected and unaffected side. Musculoskelet Sci Pract. 2019 Feb;39:136-143. doi: 10.1016/j.msksp.2018.12.006. Epub 2018 Dec 21.
PubMed 30593940Brandt M, Danneels L, Meirezonne H, Van Oosterwijck J, Willems T, Matheve T. Clinically assessed lumbopelvic sensorimotor control tests in low back pain: are they actually valid? A systematic review according to COSMIN guidelines. Musculoskelet Sci Pract. 2024 Jun;71:102953. doi: 10.1016/j.msksp.2024.102953. Epub 2024 Apr 7.
PubMed 38604022
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Trunk Muscle Activation in Patients With Recurrent Low Back Pain in Remission
- ClinicalTrials.gov ID
- NCT06452030
- Acronym / sponsor ID
- MAS / ONZ-2022-0310
- Conditions
- Recurrent Low Back Pain, Remission
- Keywords
- Low back pain, Motor control, Exercise, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- VZW Educatieve Lichaamsbeweging
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 11 Jun 2024 (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 first aim of the study is to investigate the effects of a single therapy session on trunk muscle activation and lumbopelvic sensorimotor control in persons with recurrent low back pain in remission.
The second aim of the study is to examine the convergent validity of (in)voluntary multifidus activation by means of inspection and palpation during two clinically assessed lumbopelvic sensorimotor control tests in persons with recurrent low back pain in remission. The convergent validity will be examined by calculating the relationship between (1) the clinical score of (in)voluntary multifidus activation, (2) back muscle activation during the same tests measured simultaneously with electromyography and (3) trunk muscle activation during other functional movements measured with electromyography.
The third aim of the study is to investigate the convergent validity of a left-right discrimination test by calculating the relationship between (1) the left-right discrimination test, (2) position-reposition test, (3) the Fremantle Back Awareness Questionnaire and (4) the Photograph Series of Daily Activities Scale.
Detailed description
Low back pain (LBP) is a very common musculoskeletal disorder. Previous research has already demonstrated that trunk muscle function and sensorimotor control (SMC) are altered in people with LBP, which may be an important underlying mechanism contributing to their pain. While there is some evidence regarding the immediate effects of exercise therapy on back muscle function (i.e., earlier onset of activity after one therapy session), the effects of a single therapy session on functional movements and clinically assessed SMC tests in patients with recurrent LBP in remission have never been investigated.
Inspection and palpation are often used in clinical settings to detect lumbopelvic SMC changes in people with LBP. If lumbopelvic SMC changes are noted during the clinical examination, specific SMC therapy can be implemented into the treatment plan. Thus, it is critical that the clinically assessed lumbopelvic SMC tests are sufficiently valid. An important prerequisite is that the clinically assessed SMC parameter is related to objectively measured SMC parameters during the same test. However, clinically assessed lumbopelvic SMC tests are often performed in standardized and less functional positions (e.g., prone lying). As such, the question arises whether results from clinically assessed SMC tests are associated with objective SMC parameters evaluated during functional activities relevant for the individual patient (e.g., lifting). Our systematic review showed that only one clinically assessed lumbopelvic SMC test had sufficient convergent validity with low quality of evidence (Brandt et al., 2024). Moreover, no studies investigated the relationships between clinically assessed lumbopelvic SMC tests and objectively measured SMC parameters during a functional task. Further high-quality studies are therefore needed.
In addition, the left-right discrimination test is also accessible in clinical settings. The left-right discrimination test assesses a person's body perception. During this test, the participant must view images on a computer of a person with the trunk flexed or rotated to the left or right. The participant must indicate as quickly and accurately as possible which side of the trunk of the person in the image is bent or turned. Another way to assess body perception is by using the Fremantle Back Awareness Questionnaire, of which the Dutch version was recently validated. It has been suggested that body perception is the result of the interaction of internal "body maps," sensory information, motor output, and beliefs and perceptions about the body. However, the relationship between the left-right discrimination test, the position-reposition test, and the Fremantle Back Awareness Questionnaire has not yet been explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study model is parallel. Participants with recurrent low back pain in remission will be randomly allocated to receive either (1) specific sensorimotor control training, (2) general extension training or (3) fascia therapy (i.e. parallel study model).
| Arm | Type | Receives |
|---|---|---|
| Specific sensorimotor control training | Experimental | Behavioral: Specific sensorimotor control trainingOne low-load treatment session of selective multifidus activation. |
| Aspecific extension training | Active comparator | Behavioral: Aspecific extension trainingOne low-load treatment session of back muscle activation. |
| Fascia training | Experimental | Behavioral: Fascia trainingOne low-load treatment session of general movement exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People between 18-65 years old
- Having recurrent non-specific low back pain (LBP) in remission at enrolment:
- Having a dominant flexion movement pattern/ neutral movement pattern
Key exclusion criteria (9 listed)
- People <18 years old or >65 years old
- Having any other type of non-specific LBP (acute, subacute, chronic).
- Having an active extension movement pattern
- Having any type of blood clotting disorder
- People 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 |
|---|---|---|
| Specific sensorimotor control trainingParticipants allocated to the specific motor control group will receive sensorimotor training of the multifidus muscle. | Behavioural | Specific sensorimotor control training |
| Aspecific extension trainingParticipants allocated to the aspecific group will receive spinal extension exercises. | Behavioural | Aspecific extension training |
| Fascia trainingParticipants allocated to the fascia group will receive general movement exercises. | Behavioural | Fascia training |
Primary outcome
Trunk muscle onset during the rapid arm movement test
Time frame: Baseline
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: Immediately after therapy
Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.
14 secondary outcomes
Trunk muscle (co-)activation
Time frame: Baseline
Trunk muscle (co-)activation
Time frame: Immediately after therapy
Back muscle activation
Time frame: Baseline
Back muscle activation
Time frame: Immediately after therapy
Voluntary multifidus activation
Time frame: Baseline
Voluntary multifidus activation
Time frame: Immediately after therapy
Involuntary multifidus activation
Time frame: Baseline
Involuntary multifidus activation
Time frame: Immediately after therapy
Lumbar proprioception
Time frame: Baseline
Left-right discrimination test
Time frame: Baseline
Disability (questionnaire)
Time frame: Baseline
Body perception (questionnaire)
Time frame: Baseline
Kinesiophobia
Time frame: Baseline
Perceived harmfulness
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 12438991de Vet HC, Heymans MW, Dunn KM, Pope DP, van der Beek AJ, Macfarlane GJ, Bouter LM, Croft PR. Episodes of low back pain: a proposal for uniform definitions to be used in research. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2409-16. doi: 10.1097/01.BRS.0000030307.34002.BE.
- Background: PubMed 21193932Stanton TR, Latimer J, Maher CG, Hancock MJ. A modified Delphi approach to standardize low back pain recurrence terminology. Eur Spine J. 2011 May;20(5):744-52. doi: 10.1007/s00586-010-1671-8. Epub 2010 Dec 31.
- Background: PubMed 17476489Tsao H, Hodges PW. Immediate changes in feedforward postural adjustments following voluntary motor training. Exp Brain Res. 2007 Aug;181(4):537-46. doi: 10.1007/s00221-007-0950-z. Epub 2007 May 3.
- Background: PubMed 20434958Tsao H, Druitt TR, Schollum TM, Hodges PW. Motor training of the lumbar paraspinal muscles induces immediate changes in motor coordination in patients with recurrent low back pain. J Pain. 2010 Nov;11(11):1120-8. doi: 10.1016/j.jpain.2010.02.004.
- 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.
- Background: PubMed 30593940Meier R, Iten P, Luomajoki H. Clinical assessments can discriminate altered body perception in patients with unilateral chronic low back pain, but not differences between affected and unaffected side. Musculoskelet Sci Pract. 2019 Feb;39:136-143. doi: 10.1016/j.msksp.2018.12.006. Epub 2018 Dec 21.
- Background: PubMed 38604022Brandt M, Danneels L, Meirezonne H, Van Oosterwijck J, Willems T, Matheve T. Clinically assessed lumbopelvic sensorimotor control tests in low back pain: are they actually valid? A systematic review according to COSMIN guidelines. Musculoskelet Sci Pract. 2024 Jun;71:102953. doi: 10.1016/j.msksp.2024.102953. Epub 2024 Apr 7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thomas Matheve, Prof contact
Lieven Danneels, Prof 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?
A study testing Aspecific extension training and Fascia training in people with Recurrent Low Back Pain and Remission, 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lieven Danneels, Prof (+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). 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 NCT06452030, which also lists 9 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 11 Jun 2024.