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

Low Back Pain Clinical Trial

— Back-to-Back  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851196
• Other study ID #: S67192
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Hasselt University
• Contact: Lotte Janssens, PhD
• Phone: +3211292174
• Email: lotte.janssens[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

Intervention

Other:
• Proprioceptive 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.

Locations

Country	Name	City	State
Belgium	REVAL Rehabilitation Research Center, Hasselt University	Diepenbeek
Belgium	Department of Rehabilitation Sciences, KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age (years) will be recorded.	Immediately after inclusion
Other	Sex (male/female)	Sex will be recorded.	Immediately after inclusion
Other	Highest level of education	Highest level of education will be recorded.	Immediately after inclusion
Other	Current employment status	Current employment status will be recorded.	Immediately after inclusion
Other	Body weight (kg)	Body weight (kg) will be recorded.	Immediately after inclusion
Other	Height (cm)	Height (cm) will be recorded.	Immediately after inclusion
Other	Handedness (left, right)	Handedness will be recorded.	Immediately after inclusion
Other	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.	Immediately after inclusion
Other	Duration of low back pain (only for patients)	The duration of low back pain (months) will be recorded.	Immediately after inclusion
Other	Medication use (only for patients)	Medication use will be recorded.	Immediately after inclusion
Primary	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.	At baseline 1 (t= 0 weeks)
Primary	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.	At baseline 2 (t= 8 weeks)
Primary	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.	After 8 weeks of training (t= 16 weeks)
Primary	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.	After 16 weeks of training (t= 24 weeks)
Primary	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.	16 weeks after the end of training (t= 40 weeks)
Primary	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.	At t= 0 weeks
Primary	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.	At baseline 2 (t= 8w, 2nd baseline)
Primary	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.	After 16 weeks of training (t= 24 weeks)
Primary	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.	16 weeks after the end of training (t= 40 weeks)
Primary	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.	At t= 0 weeks
Primary	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.	At baseline 2 (t= 8 weeks)
Primary	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.	After 16 weeks of training (t= 24 weeks)
Primary	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.	16 weeks after the end of training (t= 40 weeks)
Primary	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).	At baseline 1 (t= 0 weeks)
Primary	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).	At baseline 2 (t= 8 weeks)
Primary	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).	After 8 weeks of training (t= 16 weeks)
Primary	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).	After 16 weeks of training (t= 24 weeks)
Primary	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).	16 weeks after the end of training (t= 40 weeks)
Primary	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).	At baseline 1 (t= 0 weeks)
Primary	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).	At baseline 2 (t= 8 weeks)
Primary	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).	After 8 weeks of training (t= 16 weeks)
Primary	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).	After 16 weeks of training (t= 24 weeks)
Primary	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).	16 weeks after the end of training (t= 40 weeks)
Secondary	Disability due to low back pain	Participants will be asked to complete the Modified Low Back Pain Disability Questionnaire.	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)
Secondary	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	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)
Secondary	Pain-related fear of movement	Participants will be asked to complete the Tampa Scale for Kinesiophobia.	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)
Secondary	Fear-avoidance beliefs about physical activity and work	Participants will be asked to complete the Fear-Avoidance Beliefs Questionnaire.	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)
Secondary	Pain catastrophizing	Participants will be asked to complete the Pain Catastrophizing Scale.	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)
Secondary	Anxiety and depression	Participants will be asked to complete the Hospital Anxiety and Depression Scale.	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)
Secondary	Habitual physical activity	Participants will be asked to complete the Baecke Questionnaire.	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)