ClinicalTrials.gg
RecruitingNCT05851196Back-to-BackUpdated Sep 17, 2026

The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain

An observational study in Low Back Pain and Back Pain Lower Back Chronic, sponsored by Hasselt University. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Hasselt University · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Low Back Pain
  • Back Pain Lower Back Chronic

Browse trials for

Keywords

  • Proprioceptive postural control
  • Muscle volume
  • Muscle activation
  • Muscle oxygenation
  • Muscle fiber type composition
  • Proprioceptive training
03

In context

Low Back Pain

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 481 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Hasselt University is the lead sponsor of 204 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Flemish Brabant

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • of 30 kg/m² or more
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with non-specific low back pain

    Individuals with chronic non-specific ow back pain

    Other: Proprioceptive training

  • Healthy controls

    Healthy, age- and sex-matched individuals without low back pain

Interventions

  • OtherProprioceptive training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline 1 (t= 0 weeks)

  2. 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.

    Time frame: At baseline 2 (t= 8 weeks)

  3. 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.

    Time frame: After 8 weeks of training (t= 16 weeks)

  4. 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.

    Time frame: After 16 weeks of training (t= 24 weeks)

  5. 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.

    Time frame: 16 weeks after the end of training (t= 40 weeks)

  6. 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.

    Time frame: At t= 0 weeks

  7. 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.

    Time frame: At baseline 2 (t= 8w, 2nd baseline)

  8. 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.

    Time frame: After 16 weeks of training (t= 24 weeks)

  9. 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.

    Time frame: 16 weeks after the end of training (t= 40 weeks)

  10. 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.

    Time frame: At t= 0 weeks

  11. 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.

    Time frame: At baseline 2 (t= 8 weeks)

  12. 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.

    Time frame: After 16 weeks of training (t= 24 weeks)

  13. 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.

    Time frame: 16 weeks after the end of training (t= 40 weeks)

  14. 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).

    Time frame: At baseline 1 (t= 0 weeks)

  15. 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).

    Time frame: At baseline 2 (t= 8 weeks)

  16. 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).

    Time frame: After 8 weeks of training (t= 16 weeks)

  17. 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).

    Time frame: After 16 weeks of training (t= 24 weeks)

  18. 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).

    Time frame: 16 weeks after the end of training (t= 40 weeks)

  19. 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).

    Time frame: At baseline 1 (t= 0 weeks)

  20. 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).

    Time frame: At baseline 2 (t= 8 weeks)

  21. 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).

    Time frame: After 8 weeks of training (t= 16 weeks)

  22. 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).

    Time frame: After 16 weeks of training (t= 24 weeks)

  23. 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).

    Time frame: 16 weeks after the end of training (t= 40 weeks)

Secondary outcomes

  1. Disability due to low back pain

    Participants will be asked to complete the Modified Low Back Pain Disability Questionnaire.

    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)

  2. 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

    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)

  3. Pain-related fear of movement

    Participants will be asked to complete the Tampa Scale for Kinesiophobia.

    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)

  4. Fear-avoidance beliefs about physical activity and work

    Participants will be asked to complete the Fear-Avoidance Beliefs Questionnaire.

    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)

  5. Pain catastrophizing

    Participants will be asked to complete the Pain Catastrophizing Scale.

    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)

  6. Anxiety and depression

    Participants will be asked to complete the Hospital Anxiety and Depression Scale.

    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)

  7. Habitual physical activity

    Participants will be asked to complete the Baecke Questionnaire.

    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)

Other outcomes

  1. Age

    Age (years) will be recorded.

    Time frame: Immediately after inclusion

  2. Sex (male/female)

    Sex will be recorded.

    Time frame: Immediately after inclusion

  3. Highest level of education

    Highest level of education will be recorded.

    Time frame: Immediately after inclusion

  4. Current employment status

    Current employment status will be recorded.

    Time frame: Immediately after inclusion

  5. Body weight (kg)

    Body weight (kg) will be recorded.

    Time frame: Immediately after inclusion

  6. Height (cm)

    Height (cm) will be recorded.

    Time frame: Immediately after inclusion

  7. Handedness (left, right)

    Handedness will be recorded.

    Time frame: Immediately after inclusion

  8. Current pain intensity (only for patients)

    Patients will be asked to rate the current intensity of pain in their lower back (and leg if present) on a Numerical Rating Scale with anchors 0= no pain and 10= worst pain.

    Time frame: Immediately after inclusion

  9. Duration of low back pain (only for patients)

    The duration of low back pain (months) will be recorded.

    Time frame: Immediately after inclusion

  10. Medication use (only for patients)

    Medication use will be recorded.

    Time frame: Immediately after inclusion

07

Study locations

2 of 2 sites recruiting
  • REVAL Rehabilitation Research Center, Hasselt University
    Diepenbeek, 3500, Belgium
    Recruiting
    • Lotte Janssens, PhD · Contactlotte.janssens@uhasselt.be
    • Nina Goossens, PhD · Contactnina.goossens@uhasselt.be
    • Lotte Janssens, PhD · Principal investigator
    • Nina Goossens, PhD · Sub investigator
    • Frank Vandenabeele, PhD · Sub investigator
    • Anouk Agten, PhD · Sub investigator
  • Department of Rehabilitation Sciences, KU Leuven
    Leuven, 3001, Belgium
    Recruiting
    • Simon Brumagne, PhD · Contactsimon.brumagne@kuleuven.be
    • Vasiliki Karagiannopoulou, MSc · Contactvasiliki.karagiannopoulou@kuleuven.be
    • Simon Brumagne, PhD · Principal investigator
    • Lieven Moke, PhD · Sub investigator
    • Kaat Desloovere, PhD · Sub investigator
    • Zafeiris Louvaris, PhD · Sub investigator
    • Vasiliki Karagiannopoulou, MSc · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851196
Lead sponsor
Hasselt University
Collaborators
KU Leuven
Responsible party
Lotte Janssens (Prof. Dr., Hasselt University) — Principal investigator
First posted
May 9, 2023
Start date
Jan 15, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Lotte Janssens, PhD
Contact
lotte.janssens@uhasselt.be
+3211292174
Simon Brumagne, PhD
Contact
simon.brumagne@kuleuven.be
Lotte Janssens, PhD
principal investigator · Hasselt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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