Clinical trial NCT05851196: The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Official title: Back to Back: the Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2023-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Flemish Brabant

Brief 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.

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.

Eligibility criteria: 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
* 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

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
* Body mass index of 30 kg/m² or more

Primary outcomes:
measure: Proprioceptive postural control at baseline 1 (t= 0 weeks)
timeFrame: At baseline 1 (t= 0 weeks)
measure: Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients)
timeFrame: At baseline 2 (t= 8 weeks)
measure: Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients)
timeFrame: After 8 weeks of training (t= 16 weeks)
measure: Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients)
timeFrame: After 16 weeks of training (t= 24 weeks)
measure: Proprioceptive postural control 16 weeks after the end of training (t= 40 weeks) (only for patients)
timeFrame: 16 weeks after the end of training (t= 40 weeks)
measure: Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)
timeFrame: At t= 0 weeks
measure: Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
timeFrame: At baseline 2 (t= 8w, 2nd baseline)
measure: Macroscopic characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
timeFrame: After 16 weeks of training (t= 24 weeks)
measure: Macroscopic characteristisc of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
timeFrame: 16 weeks after the end of training (t= 40 weeks)
measure: Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls)
timeFrame: At t= 0 weeks
measure: Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
timeFrame: At baseline 2 (t= 8 weeks)
measure: Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
timeFrame: After 16 weeks of training (t= 24 weeks)
measure: Microscopic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
timeFrame: 16 weeks after the end of training (t= 40 weeks)
measure: Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 1 (t= 0 weeks)
timeFrame: At baseline 1 (t= 0 weeks)
measure: Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients)
timeFrame: At baseline 2 (t= 8 weeks)
measure: Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 8 weeks of training (t= 16 weeks) (only for patients)
timeFrame: After 8 weeks of training (t= 16 weeks)
measure: Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles after 16 weeks of training (t= 24 weeks) (only for patients)
timeFrame: After 16 weeks of training (t= 24 weeks)
measure: Hemodynamic muscle characteristics of the lumbar multifidus and erector spinae muscles 16 weeks after the end of training (t= 40 weeks) (only for patients)
timeFrame: 16 weeks after the end of training (t= 40 weeks)
measure: Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 1 (t= 0 weeks)
timeFrame: At baseline 1 (t= 0 weeks)
measure: Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae at baseline 2 (t= 8 weeks) (only for patients)
timeFrame: At baseline 2 (t= 8 weeks)
measure: Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 8 weeks of training (t= 16 weeks) (only for patients)
timeFrame: After 8 weeks of training (t= 16 weeks)
measure: Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae after 16 weeks of training (t= 24 weeks) (only for patients)
timeFrame: After 16 weeks of training (t= 24 weeks)
measure: Electrophysiological muscle characteristics of the lumbar multifidus and erector spinae 16 weeks after the end of training (t= 40 weeks) (only for patients)
timeFrame: 16 weeks after the end of training (t= 40 weeks)
Secondary outcomes:
measure: Disability due to low back pain
timeFrame: 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)
measure: Risk for future work disability due to low back pain
timeFrame: 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)
measure: Pain-related fear of movement
timeFrame: 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)
measure: Fear-avoidance beliefs about physical activity and work
timeFrame: 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)
measure: Pain catastrophizing
timeFrame: 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)
measure: Anxiety and depression
timeFrame: 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)
measure: Habitual physical activity
timeFrame: 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:
measure: Age
timeFrame: Immediately after inclusion
measure: Sex (male/female)
timeFrame: Immediately after inclusion
measure: Highest level of education
timeFrame: Immediately after inclusion
measure: Current employment status
timeFrame: Immediately after inclusion
measure: Body weight (kg)
timeFrame: Immediately after inclusion
measure: Height (cm)
timeFrame: Immediately after inclusion
measure: Handedness (left, right)
timeFrame: Immediately after inclusion
measure: Current pain intensity (only for patients)
timeFrame: Immediately after inclusion
measure: Duration of low back pain (only for patients)
timeFrame: Immediately after inclusion
measure: Medication use (only for patients)
timeFrame: Immediately after inclusion
Locations:
city: Diepenbeek
country: Belgium
facility: REVAL Rehabilitation Research Center, Hasselt University
city: Leuven
country: Belgium
facility: Department of Rehabilitation Sciences, KU Leuven
Study officials:
affiliation: Hasselt University
name: Lotte Janssens, PhD
role: PRINCIPAL_INVESTIGATOR
References: