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临床试验/NCT03705676
NCT03705676已完成不适用

Unraveling the Puzzle of Back Pain Chronicity: an Integrative Perspective on Sensorimotor Control and Maladaptive Cognitive Processes

University Ghent2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2017年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
2
主要终点
Contingent Negative Variation

研究概览

简要总结

This study aims at examining the influence of both threat of experimentally induced pain and clinical low back pain (LBP) on trunk motor control on the one hand and brain activity related to movement preparation on the other hand. Therefore, 3 groups are studied: healthy controls, people with recurrent LBP, and people with chronic LBP. A comparison in electromyography (EMG) of the trunk muscles and electroencephalography (EEG) activity between the 3 groups will be made in 2 conditions: a control condition without experimental pain on 1 test day, and a fear condition with experimental pain on another test day. In both conditions a motor control task will be performed and muscle and brain activity will be measured during each motor control task.

It is hypothesised that motor control will be different between the 3 groups in both conditions, i.e. delayed trunk muscle onset in LBP groups compared with controls. With regards to the brain activity, it is expected that preparation for movement will also be delayed in the LBP groups. Furthermore, it is expected that the fear condition will entail differences in both EMG and EEG within each group.

详细描述

March 2017 - April 2018. 30 healthy participants, 30 recurrent and 30 chronic LBP patients all aged 18-45 and of both genders were tested for 2 conditions on 2 separate days, i.e. a control condition (C) on 1 test day; a fear (F) condition consisting out of threat (T) and no threat trials (NT) on another test day. The order of test days was randomized.

1 block of 240 rapid arm movements (RAM) with the dominant arm was performed per condition, while electroencephalography (EEG) of the brain and surface electromyography (sEMG) of the Internal Oblique/Transversus Abdominis, External Oblique, Multifidus and Iliocostalis Lumborum pars Thoracis muscles were measured bilaterally. sEMG of the Anterior Deltoid muscle of the dominant arm was also measured. This RAM was used to induce an internal perturbation to the postural balance of subjects and is an often used task in the study of trunk motor control. Midway the RAM block, the participants got a short intermission of 90 seconds seated rest. Both conditions consisted of a warning cue (colored dot on a screen) followed by a go cue (arrow indicating either an upwards or downwards rapid arm movement) or a no-go cue ('STOP') and 12 seconds rest before the next trial. Harmless vibrotactile stimuli were always administered to the low back region during the appearance of the warning cue. During the C, a white warning cue was presented (safe cue), meaning that the RAM would never be accompanied by a painful electrocutaneous stimulus in that condition. During the F a safe (no threat) or a threatening warning cue could be presented (50-50%); in 25% of the trials after the threatening cue an electrocutaneous stimulus was given to the lower back region; the trials after the no threat cue were never accompanied with painful stimuli.

The intensity of the electrocutaneous stimulus was self-determined by participants through a staircase paradigm and was administered by a digitimer system.

At the beginning of each test day several questionnaires were also administered to control for psychological factors and physical activity, i.e. Central Sensitization Index (CSI), Hospital Anxiety and Depression Scale (HADS), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Pain Vigilance and Awareness Questionnaire (PVAQ), Roland-Morris Disability Questionnaire (RMDQ), International Physical Activity Questionnaire (IPAQ) and a general questionnaire regarding socio-demographic information and history of complaints. Furthermore, complaint specific questionnaires were also administered, but only for the clinical populations (RLBP and CLBP)

Statistical analysis will be performed to assess whether and to what extent both threat and LBP might influence motor control as measured with EMG during RAM. Furthermore, the effect of both on cortical movement preparation and somatosensory processing will also be assessed based on the EEG measurements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Participants are aware that electrocutaneous stimulation might occur during the fear condition and never during the control condition. This is of paramount importance, as the expectancy of a painful stimulus is the main difference between both conditions.

The researcher that will perform the EMG-analysis, i.e. onset determination of the various muscles that were measured, will be blinded for participant, condition and muscle during that process. EEG-data does not have to be blinded as data processing is computer based and not subjectable to subjective bias of a researcher.

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

  • Healthy adult subjects.

排除标准

  • People with a history of pain or current pain
  • severe pathologies
  • cardiorespiratory disorders
  • neurological disorders
  • vestibular disorders
  • endocrinologic disorders
  • psychiatric and cognitive disorders
  • colour blindness
  • sleeping disorders
  • psychological disorders or major depressions
  • major surgery to the spine or upper limbs
  • clinically relevant malalignments and deformities
  • malignancies
  • substance abuse of alcohol or drugs
  • consumption of analgesics without prescription 24 hours or with prescription two weeks before testing
  • use of psychotropic medication
  • extreme physical activities two days before testing
  • professional athletes
  • pregnant women or women < 1 year postnatally
  • Inclusion Criteria:
  • People with non-specific recurrent LBP for at least 2 episodes last year. (1 episode = >24h complaints; 2 episodes are separated by a painfree period of at least 1 month)
  • Exclusion Criteria:
  • specific reason for LBP (e.g. herniation <2y, fracture, rheumatic disease,...)
  • severe pathologies
  • cardiorespiratory disorders
  • neurological disorders
  • vestibular disorders
  • endocrinologic disorders
  • psychiatric and cognitive disorders
  • colour blindness
  • sleeping disorders
  • psychological disorders or major depressions
  • major surgery to the spine or upper limbs
  • clinically relevant malalignments and deformities
  • malignancies
  • substance abuse of alcohol or drugs
  • consumption of analgesics without prescription 24 hours or with prescription two weeks before testing
  • use of psychotropic medication
  • extreme physical activities two days before testing
  • professional athletes
  • pregnant women or women < 1 year postnatally
  • Inclusion Criteria:
  • People with non-specific chronic LBP for at least 3 days a week and this for at least 3 months on a row.
  • Exclusion Criteria:
  • specific reason for LBP (e.g. herniation <2y, fracture, rheumatic disease,...)
  • severe pathologies
  • cardiorespiratory disorders
  • neurological disorders
  • vestibular disorders
  • endocrinologic disorders
  • 另有 13 项未显示

结局指标

主要结局

Contingent Negative Variation

时间窗: 2 hours

A cortical EEG-potential that reflects movement preparation in the timeframe between a warning cue and a go cue in Volt.

Trunk muscle EMG latency

时间窗: 2 hours

Latency of the activation onset of the trunk muscles on EMG compared to prime mover onset (Anterior Deltoid) in milliseconds.

Somatosensory Evoked Potentials

时间窗: 2 hours

Cortical EEG-potentials that reflect the awareness and processing of somatosensory information, in this case vibrotactile stimuli on the lower back in Herz.

次要结局

  • General Questionnaire - Short(10 minutes at the beginning of test day 2)
  • Hospital Anxiety and Depression Scale (HADS)(7 minutes at the beginning of test day 1 and 2, which are minimally separated by 5 days between test days.)
  • Pain Catastrophizing Scale (PCS)(7 minutes at the beginning of test day 1 and 2, which are minimally separated by 5 days between test days.)
  • Pain Vigilance and Awareness Questionnaire (PVAQ)(8 minutes at the beginning of test day 1 and 2, which are minimally separated by 5 days between test days.)
  • Rating of Perceived Exertion/Borg(After each RAM block, with a duration of 5 seconds. This in both test day 1 and 2, which are minimally separated by 5 days between test days.)
  • International Physical Activities Questionnaire(15 minutes at the beginning of each of two test days, which are minimally separated by 5 days between test days.)
  • General Questionnaire(10 minutes at the beginning of test day 1)
  • Visual Analogue Scale for Pain(Before, midway and after each RAM block, with a duration of 10 seconds. This in both test day 1 and 2, which are minimally separated by 5 days between test days.)
  • Roland Morris Disability Questionnaire (RMDQ)(10 minutes at the beginning of test day 1 and 2, which are minimally separated by 5 days between test days.)
  • Tampa Scale for Kinesiophobia (TSK)(8 minutes at the beginning of test day 1 and 2, which are minimally separated by 5 days between test days.)
  • Central Sensitization Inventory (CSI)(10 minutes at the beginning of test day 1 and 2, which are minimally separated by 5 days between test days.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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