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临床试验/NCT03848247
NCT03848247Unknown不适用

The Effect of Experimental Neck Pain in Healthy Participants - The Transition From Acute to Ongoing Pain

Aalborg University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change in pressure pain threshold (PPT) measured with a handheld pressure algometer

研究概览

简要总结

This study investigates if/how an experimentally applied muscle pain/soreness, lasting for some days may affect brain activity, balance, movement patterns, muscle function and pain sensitivity in a healthy population

详细描述

All included healthy volunteers will participate in test-sessions on 4 separate days over approximately 2 weeks.

During the study participants will be randomised into and either a control group (injection of isotonic saline into a neck muscle) or neck pain group (injection of Nerve Growth Factor (NGF) into a neck muscle).

Alle participants tested with regards to:

Brain activity related to neck muscles will be estimated using TMS Balance will be tested using a force place Body movements will be recorded using 3D tracking Muscle activity will be estimated using electromyography (EMG)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women aged 18-50 years
  • Only for sub-projects 1 and 2: Right-handed
  • Able to speak, read and understand Danish and English

排除标准

  • Pain from the neck or shoulder area during the past 6 months
  • Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
  • Former surgery in neck or shoulder
  • Current or previous chronic or recurrent pain condition
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Regular use of analgesics
  • Abnormally disrupted sleep in the last 24 hours preceding the experiment
  • Lack of ability to cooperate
  • Unable to pass the TASS safety screening questionnaire for TMS

结局指标

主要结局

Change in pressure pain threshold (PPT) measured with a handheld pressure algometer

时间窗: Day 0, 2,4 and 15

PPT will be assessed over head, neck, arm and leg sites.

Change in motor evoked potentials

时间窗: Day 0, 4 and 15

Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles

Change in Body movement

时间窗: Day 0, 4 and 15

3D recordings of body movements

次要结局

  • The Big Five Inventory (BFI)(Day 2)
  • Change in standing balance(Day 0, 4 and 15)
  • Disability(Day 0, 2,4 and 15)
  • Pain Catastrophizing Scale (13 item questionnaire)(Day 2)
  • Change in muscle activity (EMG)(Day 0, 4 and 15)
  • Change in perceived pain: McGill Pain Questionnaire(Day 0, 2,4 and 15)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Steffan Wittrup Christensen

Assistant professor

Aalborg University

研究点 (2)

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