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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Proprioceptive postural control at baseline 1 (t= 0 weeks) [Срок оценки: At baseline 1 (t= 0 weeks)]
• Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients) [Срок оценки: At baseline 2 (t= 8 weeks)]
• Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients) [Срок оценки: After 8 weeks of training (t= 16 weeks)]
• Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients) [Срок оценки: After 16 weeks of training (t= 24 weeks)]
• Proprioceptive postural control 16 weeks after the end of training (t= 40 weeks) (only for patients) [Срок оценки: 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) [Срок оценки: At t= 0 weeks]
• Macroscopic characteristiscs of the lumbar multifidus and erector spinae muscles at baseline 2 (t= 8 weeks) (only for patients) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At t= 0 weeks]

Вторичные конечные точки (7)

• Disability due to low back pain [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Бельгия · 2 центра

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

Идентификаторы

NCT: NCT05851196 · S67192

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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