跳至主要内容
临床试验/NCT05706103
NCT05706103招募中不适用

Efficacy of Specific Skilled Motor Versus General Exercise Training on Peripheral Muscle and Central Brain Alterations in Patients with Recurrent Low Back Pain

University Ghent2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
62
试验地点
2
主要终点
Brain macro-structure

研究概览

简要总结

Exercise therapy has been shown to be effective in decreasing pain and improving function for patients with recurrent low back pain (LBP). Research on the mechanisms that trigger and/or underlie the effects of exercise therapy on LBP problems is of critical importance for the prevention of recurring or persistence of this costly and common condition. One factor that seems to be crucial within this context is the dysfunction of the back muscles. Recent pioneering results have shown that individuals with recurring episodes of LBP have specific dysfunctions of these muscles (peripheral changes) and also dysfunctions at the cortical level (central changes). This work provides the foundation to take a fresh look at the interplay between peripheral and central aspects, and its potential involvement in exercise therapy. The current project will draw on this opportunity to address the following research questions: What are the immediate (after a single session) and the long-term effects (after 18 repeated sessions) of exercise training on: (1) back muscle structure; (2) back muscle function; (3) the structure of the brain; (4) and functional connectivity of the brain. This research project also aims to examine whether the effects are dependent on how the training was performed. Therefore a specific versus a general exercise program will be compared.

详细描述

Although the cause of persistent non-specific LBP remains unknown, structural and functional alterations of the brain and paravertebral muscles have been proposed as underlying mechanisms. As it is hypothesized that these alterations contribute to, or maintain non-specific LBP, exercise therapy is a key element in the rehabilitation of reoccurring LBP. Specific training of sensorimotor control of the lumbopelvic region (i.e. specific skilled motor training) has shown to decrease pain and disability in patients with LBP, but has not been found superior to other forms of exercise training regarding improvements in clinical outcome measures. On the other hand, this type of training seems to differentially impact the recruitment of the back muscles compared to general exercise training. However, research using multiple treatment sessions and including follow-up outcome assessments is scarce. Furthermore, it is unknown if improvements may be attributed to measurable peripheral changes in the muscle and/or central neural adaptations in the brain. The primary aim of this study is to examine the short and long-term effects of specific skilled motor control training versus unspecific general extension training on pain, functional disability, brain structure/function and muscle structure/function in recurrent LBP patients.

Method: In this double-blind, randomized controlled clinical trial 62 recurrent LBP patients will be randomly allocated (1:1) to receive either specific skilled motor training (i.e. the experimental group) or general extension training (i.e. control group). Each training group will receive 13 weeks of treatment, during which a total of 18 supervised treatment sessions will be delivered in combination with an individualized home-exercise program. Both groups will first receive low-load training (i.e. at 25-30% of the individual's repetition maximum, sessions 1-9) followed by high-load training (i.e. at 40-60% of the individual's one repetition maximum, sessions 10-18). Primary outcome measures include: LBP-related pain and disability (RMDQ, NRS and Margolis pain diagram), lumbar muscle structure and function (Dixon MRI and mf-MRI) and brain structure and function (MRI, DTI and fMRI). Secondary measures include: lumbopelvic control and proprioception (thoracolumbar dissociation test and position-reposition test), trunk muscle activity (RAM and QFRT) and psychosocial factors, including measures of physical activity (IPAQ-LF, SF-36), pain cognitions and perceptions (PCS, PCI and PVAQ), anxiety and depression (HADS), and kinesiophobia (TSK). Experimental data collection will be performed at baseline, immediately following the low-load training (i.e. after the 9th supervised treatment session), following the high-load training (i.e. after the 18th supervised treatment session), and at 3 months follow-up. Experimental data collection will comprise of magnetic resonance imaging of the brain and trunk muscles, clinical assessments assessing muscle function, and a battery of questionnaires evaluating psychosocial factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of non-specific recurrent LBP with the first onset being at least 6 months ago
  • At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP
  • Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10
  • During remission the NRS intensity for LBP should be
  • LBP should be of that severity that it limits activities of daily living
  • LBP should be of that severity that a (para)medic has been consulted at least once regarding the complaints
  • Flexion pattern of LBP

排除标准

  • Chronic LBP (i.e. duration remission <1 month)
  • Subacute LBP (i.e. first onset between 3 and 6 months ago)
  • Acute (i.e. first onset <3 months ago) LBP
  • Specific LBP (i.e. LBP proportionate to an identifiable pathology, e.g. lumbar radiculopathy)
  • Patients with neuropathic pain
  • Patients with chronic widespread pain as defined by the criteria of the 1990 ACR (i.e. fibromyalgia)
  • A lifetime history of spinal traumata (e.g. whiplash), surgery (e.g. laminectomy) or deformations (e.g. scoliosis)
  • A lifetime history of respiratory, metabolic, neurologic, cardiovascular, inflammatory, orthopedic or rheumatologic diseases
  • Concomitant therapies (i.e. rehabilitation, alternative medicine or therapies)
  • Contra-indications for MRI (e.g. suffering from claustrophobia, the presence of metallic foreign material in the body, BMI >30kg/m²)
  • Professional athletes
  • Pregnant women
  • Breastfeeding women
  • Women given birth in the last year before enrolment

结局指标

主要结局

Brain macro-structure

时间窗: At 3 months follow-up

Whole brain T1-weighted structural MRI will be acquired.

Brain micro-structure

时间窗: At 3 months follow-up

Whole-brain T2-weighted images will be obtained.

次要结局

  • Lumbopelvic proprioception(At 3 months follow-up.)
  • Anxiety and depression(At 3 months follow-up)
  • Functional brain connectivity(At 3 months follow-up)
  • Lumbar muscle function(At 3 months follow-up.)
  • Lumbopelvic control(At 3 months follow-up.)
  • Pain vigilance and awareness(At 3 months follow-up)
  • Pain catastrophizing(At 3 months follow-up)
  • Compensatory postural adjustments(At 3 months follow-up)
  • Nociceptive flexion reflex - threshold(At 3 months follow-up)
  • Conditioned pain modulation(At 3 months follow-up)
  • Health status(At 3 months follow-up)
  • Low back pain related disability(At 3 months follow-up)
  • Nociceptive flexion reflex - temporal summation(At 3 months follow-up)
  • Physical activity(At 3 months follow-up.)
  • Pain coping(At 3 months follow-up)
  • Kinesiophobia(At 3 months follow-up)
  • Low back pain related pain(At 3 months follow-up)
  • Lumbar muscle structure(At 3 months follow-up)
  • Anticipatory postural adjustments(At 3 months follow-up)
  • Low back pain recurrence(At 12 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验