Low Back PainBack-to-BackNCT05851196
The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
An observational study of Low Back Pain and Back Pain Lower Back Chronic, run by Hasselt University at 2 sites in Belgium.
Trial summary
Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Back Pain Lower Back Chronic
- What is being tested?
- Proprioceptive training
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Jan 2024to 31 Dec 2027
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Flemish Brabant
Who may be able to join
- Patients with non-specific low back pain:
- Aged 18-60 years
- Non-specific low back pain without radicular leg pain
- Mechanical low back pain with episodes of <4 on the numerical pain rating scale and episodes of >6 on the numerical pain rating scale
- Non-specific low back pain for three months or more
- Score of 20% or more on the Modified Low Back Pain Disability Questionnaire
Show all 12Show fewer
- Informed consent to participate
- Healthy controls:
- Aged 18-60 years
- No history of low back pain needing medical treatment or resulting in a limited activity level
- No low back pain in the previous six months
- Informed consent to participate
Who cannot join
- Pregnancy
- Previous trauma or surgery to the spine, pelvis or lower limbs
- Structural spinal deformity (e.g., scoliosis)
- Neurological, neuromuscular, respiratory or systemic disease
- Central sensitization: score of 50/100 or more on the Central Sensitization Inventory
- Specific vestibular or balance problems
- Acute lower limb or neck problems
- Body mass index of 30 kg/m² or more
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Simon Brumagne, PhD contact
Belgium2 sites, 2 recruiting
- Recruiting
REVAL Rehabilitation Research Center, Hasselt University
Diepenbeek, 3500
Lotte Janssens, PhD, lotte.janssens@uhasselt.be
Nina Goossens, PhD, nina.goossens@uhasselt.be
- Recruiting
Department of Rehabilitation Sciences, KU Leuven
Leuven, 3001
Simon Brumagne, PhD, simon.brumagne@kuleuven.be
Vasiliki Karagiannopoulou, MSc, vasiliki.karagiannopoulou@kuleuven.be
About this study
Official title: Back to Back: the Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Additionally, the group of patients with non-specific low back pain will receive a 16-week, high-load proprioceptive training program. The effects of this training program on the different back muscle characteristics and proprioceptive postural control will be evaluated.
Read the detailed description
The Back-to-Back study consists of a cross-sectional study and a proof-of-concept study. The cross-sectional study aims to gain more insight into the peripheral underlying mechanisms of impaired proprioceptive postural control in patients with non-specific low back pain. Macroscopic, microscopic, hemodynamic, and electrophysiological characteristics of the lumbar multifidus and erector spinae muscles will be compared between patients with non-specific low back pain and healthy, age- and sex-matched controls. The interrelatedness between these back muscle characteristics and the correlation with proprioceptive postural control will be examined. The most discriminating muscle characteristics will be determined based upon which phenotypes of patients with non-specific low back pain will be delineated. The proof-of-concept study aims to assess the effects of high-load proprioceptive training on back muscle characteristics and proprioceptive postural control in patients with non-specific low back pain.
- Conditions
- Low Back Pain, Back Pain Lower Back Chronic
- Being tested
- Proprioceptive training
- Keywords
- Proprioceptive postural control, Muscle volume, Muscle activation, Muscle oxygenation, Muscle fiber type composition, Proprioceptive training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive trainingOther
A physiotherapist tailors the exercises to the patient's functional demands and pain- or fear-inducing activities. Guided by the therapist, patients look for ways to integrate the exercises into their daily life activities. Each week, patients receive feedback from the physiotherapist, and the training program is gradually progressed. The patients are instructed to perform the exercises daily, integrated into their daily activities, hobbies, and work. The program contains: (1) exercises to improve the sense of posture and movement, (2) exercises to correct the reference frame from which patients control posture and movement, (3) muscle control exercises, (4) exercises to increase variability in postures and movement patterns, (5) functionality: patients search for ways to correct and integrate alternative postures and movement patterns into their daily life, (6) high training frequency and high load, (7) focus on sensing, localizing and differentiating, rather than movement control.
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-specific low back pain | Individuals with chronic non-specific ow back pain Receives: Other: Proprioceptive training | |
| Healthy controls | Healthy, age- and sex-matched individuals without low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proprioceptive postural control at baseline 1 (t= 0 weeks)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Measured: At baseline 1 (t= 0 weeks)
Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Measured: At baseline 2 (t= 8 weeks)
Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Measured: After 8 weeks of training (t= 16 weeks)
Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Measured: After 16 weeks of training (t= 24 weeks)
Proprioceptive postural control 16 weeks after the end of training (t= 40 weeks) (only for patients)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Measured: 16 weeks after the end of training (t= 40 weeks)
Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Measured: At t= 0 weeks
Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Measured: At baseline 2 (t= 8w, 2nd baseline)
Macroscopic characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Measured: After 16 weeks of training (t= 24 weeks)
Macroscopic characteristisc of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Measured: 16 weeks after the end of training (t= 40 weeks)
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Measured: At t= 0 weeks
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Measured: At baseline 2 (t= 8 weeks)
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Measured: After 16 weeks of training (t= 24 weeks)
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Measured: 16 weeks after the end of training (t= 40 weeks)
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 1 (t= 0 weeks)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: At baseline 1 (t= 0 weeks)
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: At baseline 2 (t= 8 weeks)
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 8 weeks of training (t= 16 weeks) (only for patients)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: After 8 weeks of training (t= 16 weeks)
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: After 16 weeks of training (t= 24 weeks)
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: 16 weeks after the end of training (t= 40 weeks)
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 1 (t= 0 weeks)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: At baseline 1 (t= 0 weeks)
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 2 (t= 8 weeks) (only for patients)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: At baseline 2 (t= 8 weeks)
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 8 weeks of training (t= 16 weeks) (only for patients)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: After 8 weeks of training (t= 16 weeks)
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 16 weeks of training (t= 24 weeks) (only for patients)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: After 16 weeks of training (t= 24 weeks)
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae 16 weeks after the end of training (t= 40 weeks) (only for patients)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Measured: 16 weeks after the end of training (t= 40 weeks)
Secondary outcomes (7)
Disability due to low back pain
Participants will be asked to complete the Modified Low Back Pain Disability Questionnaire.
Measured: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Risk for future work disability due to low back pain
Participants will be asked to complete the short version of the Örebro Musculoskeletal Pain Screening Questionnaire
Measured: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Pain-related fear of movement
Participants will be asked to complete the Tampa Scale for Kinesiophobia.
Measured: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Fear-avoidance beliefs about physical activity and work
Participants will be asked to complete the Fear-Avoidance Beliefs Questionnaire.
Measured: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Pain catastrophizing
Participants will be asked to complete the Pain Catastrophizing Scale.
Measured: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Anxiety and depression
Participants will be asked to complete the Hospital Anxiety and Depression Scale.
Measured: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Habitual physical activity
Participants will be asked to complete the Baecke Questionnaire.
Measured: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start15 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Lotte Janssens, Hasselt University
- Investigators
- Lotte Janssens, PhD, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851196
- Sponsor's protocol ID
- S67192
- Acronym
- Back-to-Back
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back to Back: the Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05851196
- Acronym / sponsor ID
- Back-to-Back / S67192
- Conditions
- Low Back Pain, Back Pain Lower Back Chronic
- Keywords
- Proprioceptive postural control, Muscle volume, Muscle activation, Muscle oxygenation, Muscle fiber type composition, Proprioceptive training
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 May 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.
Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Additionally, the group of patients with non-specific low back pain will receive a 16-week, high-load proprioceptive training program. The effects of this training program on the different back muscle characteristics and proprioceptive postural control will be evaluated.
Detailed description
The Back-to-Back study consists of a cross-sectional study and a proof-of-concept study. The cross-sectional study aims to gain more insight into the peripheral underlying mechanisms of impaired proprioceptive postural control in patients with non-specific low back pain. Macroscopic, microscopic, hemodynamic, and electrophysiological characteristics of the lumbar multifidus and erector spinae muscles will be compared between patients with non-specific low back pain and healthy, age- and sex-matched controls. The interrelatedness between these back muscle characteristics and the correlation with proprioceptive postural control will be examined. The most discriminating muscle characteristics will be determined based upon which phenotypes of patients with non-specific low back pain will be delineated. The proof-of-concept study aims to assess the effects of high-load proprioceptive training on back muscle characteristics and proprioceptive postural control in patients with non-specific low back pain.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with non-specific low back pain | – | Other: Proprioceptive trainingIndividuals with chronic non-specific ow back pain |
| Healthy controls | – | –Healthy, age- and sex-matched individuals without low back pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Flemish Brabant
Key inclusion criteria (12 listed)
- Aged 18-60 years
- Non-specific low back pain without radicular leg pain
- Mechanical low back pain with episodes of <4 on the numerical pain rating scale and episodes of >6 on the numerical pain rating scale
- Non-specific low back pain for three months or more
- Score of 20% or more on the Modified Low Back Pain Disability Questionnaire
Key exclusion criteria (8 listed)
- Pregnancy
- Previous trauma or surgery to the spine, pelvis or lower limbs
- Structural spinal deformity (e.g., scoliosis)
- Neurological, neuromuscular, respiratory or systemic disease
- Central sensitization: score of 50/100 or more on the Central Sensitization Inventory
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 |
|---|---|---|
| Proprioceptive trainingA physiotherapist tailors the exercises to the patient's functional demands and pain- or fear-inducing activities. Guided by the therapist, patients look for ways to integrate the exercises into their daily life activities. Each week, patients receive feedback from the physiotherapist, and the training program is gradually progressed. The patients are instructed to perform the exercises daily, integrated into their daily activities, hobbies, and work. The program contains: (1) exercises to improve the sense of posture and movement, (2) exercises to correct the reference frame from which patients control posture and movement, (3) muscle control exercises, (4) exercises to increase variability in postures and movement patterns, (5) functionality: patients search for ways to correct and integrate alternative postures and movement patterns into their daily life, (6) high training frequency and high load, (7) focus on sensing, localizing and differentiating, rather than movement control. | Other | Patients with non-specific low back pain |
Primary outcome
Proprioceptive postural control at baseline 1 (t= 0 weeks)
Time frame: At baseline 1 (t= 0 weeks)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients)
Time frame: At baseline 2 (t= 8 weeks)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients)
Time frame: After 8 weeks of training (t= 16 weeks)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients)
Time frame: After 16 weeks of training (t= 24 weeks)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Proprioceptive postural control 16 weeks after the end of training (t= 40 weeks) (only for patients)
Time frame: 16 weeks after the end of training (t= 40 weeks)
Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.
Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)
Time frame: At t= 0 weeks
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
Time frame: At baseline 2 (t= 8w, 2nd baseline)
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Macroscopic characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
Time frame: After 16 weeks of training (t= 24 weeks)
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Macroscopic characteristisc of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
Time frame: 16 weeks after the end of training (t= 40 weeks)
Muscle volume and quality will be measured with 3D freehand ultrasound, muscle cross-sectional area and thickness will be evaluated with 2D ultrasound.
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)
Time frame: At t= 0 weeks
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
Time frame: At baseline 2 (t= 8 weeks)
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
Time frame: After 16 weeks of training (t= 24 weeks)
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
Time frame: 16 weeks after the end of training (t= 40 weeks)
Fine-needle biopsies of the lumbar multifidus and erector spinae muscles will be acquired.
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 1 (t= 0 weeks)
Time frame: At baseline 1 (t= 0 weeks)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
Time frame: At baseline 2 (t= 8 weeks)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 8 weeks of training (t= 16 weeks) (only for patients)
Time frame: After 8 weeks of training (t= 16 weeks)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
Time frame: After 16 weeks of training (t= 24 weeks)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
Time frame: 16 weeks after the end of training (t= 40 weeks)
The Tissue Oxygenation Index will be recorded continuously with near-infrared spectroscopy during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 1 (t= 0 weeks)
Time frame: At baseline 1 (t= 0 weeks)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 2 (t= 8 weeks) (only for patients)
Time frame: At baseline 2 (t= 8 weeks)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 8 weeks of training (t= 16 weeks) (only for patients)
Time frame: After 8 weeks of training (t= 16 weeks)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 16 weeks of training (t= 24 weeks) (only for patients)
Time frame: After 16 weeks of training (t= 24 weeks)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae 16 weeks after the end of training (t= 40 weeks) (only for patients)
Time frame: 16 weeks after the end of training (t= 40 weeks)
Muscle activitation levels and patterns will be measured with surface electromyography during different functional postures (prone lying, usual sitting, usual standing, standing with the trunk bent 25° forward).
7 secondary outcomes
Disability due to low back pain
Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Risk for future work disability due to low back pain
Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Pain-related fear of movement
Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Fear-avoidance beliefs about physical activity and work
Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Pain catastrophizing
Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Anxiety and depression
Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
Habitual physical activity
Time frame: Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
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 17 Sep 2026.
- 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.
Simon Brumagne, PhD contact
Lotte Janssens, PhD principal investigator
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Back Pain Lower Back Chronic, run by Hasselt University at 2 sites 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 12 inclusion and 8 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Lotte Janssens, PhD (+3211292174, lotte.janssens@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proprioceptive postural control at baseline 1 (t= 0 weeks) (time frame: At baseline 1 (t= 0 weeks)). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.