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临床试验/NCT03362827
NCT03362827Unknown不适用

Assessment of Long-term Potentiation (LTP)-Like Pain Amplification in Chronic Low Back Pain Patients

Peking University People's Hospital0 个研究点目标入组 50 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Change of pain intensity to pinprick stimuli

研究概览

简要总结

The present study is aimed to assess the LTP-like pain amplification in chronic low back pain patients to explore the central and peripheral effect for pain LTP.

详细描述

This study is a cross-sectional study. Two groups, including low back pain group and healthy subjects group will be arranged in this study. 50 subjects will be recruited in each group, The healthy subjects were matched for sex and age in relation to the low back pain group. Conditioning electrical stimulation (100 Hz, repeated 5 times with 10 s intervals, 500 impulses) using circular pin electrodes will be used in both groups to induce LTP-like pain amplification. The pain intensity changes to pinprick and light touch stimuli will be compared between two groups.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21-80 years old.
  • People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.

排除标准

  • Age below 21 or over 80 years old.
  • Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, nerve root compromise confirmed by clinical neurological tests or severe cardiorespiratory diseases. Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded.
  • Healthy volunteers.
  • Inclusion Criteria:
  • Age 21-80 years old.
  • These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
  • Exclusion Criteria:
  • Age below 21 or over 80 years old.
  • These participants have presented episodes of low back pain for more than 7 days in the last 12 months.

结局指标

主要结局

Change of pain intensity to pinprick stimuli

时间窗: The pinprick sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).

Mechanical pinprick-evoked perception was assessed by three weighted pinprick stimulators which were randomly applied in the area adjacent to the conditioned site. The subjects indicated the perceived intensity on the same visual analogue scale(VAS).

次要结局

  • Change of pain intensity to single electrical stimulation (SES)(The pain ratings to SES will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).)
  • Perception Features of conditioning electrical stimulation (CES)(All subjects will rate the pain ratings during the 50 seconds stimulation.)
  • Change of pain intensity to light-stroking stimuli(The light-touch sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Chenjun

Department of Spine Surgery

Peking University People's Hospital

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