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

Overview

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.

Interventions

• 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 impro

Primary outcome measures

• Proprioceptive postural control at baseline 1 (t= 0 weeks) [Time frame: At baseline 1 (t= 0 weeks)]
• Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients) [Time frame: At baseline 2 (t= 8 weeks)]
• Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients) [Time frame: After 8 weeks of training (t= 16 weeks)]
• Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients) [Time frame: After 16 weeks of training (t= 24 weeks)]
• 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)]
• Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at t= 0 weeks (only for healthy controls) [Time frame: At t= 0 weeks]
• 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)]
• 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)]
• 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)]
• 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]

Secondary outcome measures (7)

• 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Belgium · 2 centers

• REVAL Rehabilitation Research Center, Hasselt University — Diepenbeek
• Department of Rehabilitation Sciences, KU Leuven — Leuven

Identifiers

NCT: NCT05851196 · S67192

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗