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临床试验/NCT05783362
NCT05783362已完成不适用

Pain Modulation Effectiveness: An Experimental Study Using Repeated Conditioned Pain Modulation as an Intervention and Analyzing Potential Predictors in Healthy Adults.

University of Florida2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月1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
60
试验地点
2
主要终点
Conditioned Pain Modulation as an assessment

研究概览

简要总结

Conditioned pain modulation (CPM) is the behavioral measure of diffuse noxious inhibitory control (DNIC), an endogenous pain inhibitory pathway in which pain inhibits pain. Conditioned pain modulation is less efficient in individuals with chronic pain conditions, and it is a predictor for the development of chronic pain. Continuous stimulation of central/cortical mechanisms through engaging CPM might alter pain processing and improve pain inhibition. Healthy participants will be randomly assigned to one of three groups: High Exposure (HE), Low Exposure (LE), and No Exposure (NE). Pre-and post-intervention pain sensitivity including conditioned pain modulation will be assessed. The study will assess the central pain modulatory mechanisms (measured by CPM) that have differential changes in participants who receive high exposure CPM as an intervention from those who receive low or no exposure. The study will also assess the magnitude and efficiency of CPM contributing additional variance to a regression model predicting pain sensitivity after positive and negative affect, pain anxiety, and depression are considered in the model, establishing measures of central pain processing, like CPM, as unique contributors to pain intensity.

详细描述

Background:

Pain is a widespread health condition that has a large burden on individuals, families, and society. Of the 39.4 million adults with pain that occurs most days and persists for more than three months, nearly two-thirds deem it "constantly present," and over half define it as "unbearable and excruciating". Pain may be classified as physiological and pathological. Nociceptive and inflammatory pain are physiological states that are protective and adaptive, whereas pathological pain is nonprotective and maladaptive.

The conditioned pain modulation (CPM) paradigm is a dynamic QST measure of a pain inhibitory process that lessens pain sensitivity in response to a remotely applied painful stimulus and is used to assess the ability of the person to endogenously inhibit pain. CPM may be a valuable tool in directing mechanistic-based approaches for treating painful conditions. For example, individuals with painful diabetic neuropathy and poorly functioning CPM have more significant analgesia when given duloxetine, a medication that augments conditioned pain modulation. Additionally, identifying and treating the source of pain is associated with positive changes in CPM. Healthy individuals demonstrate more efficient CPM when compared with people in pain and a systematic review of adults with chronic pain revealed that CPM efficiency improves after a reduction in pain. For example, total hip arthroplasty for treating painful osteoarthritis reduces pain and improves post-operative CPM. Collectively, these studies suggest that the CPM test has the potential to predict risk and treatment outcomes for chronic pain., therefore CPM may be considered an essential treatment moderator and mediator.

Activation of these central mechanisms (endogenous inhibitory systems) has also been proposed as the mechanism underpinning interventions used to treat various pain conditions. For example, evidence suggests that descending pain inhibitory systems (central mechanisms) play a fundamental role in mediating the analgesic effect of manipulation-induced pain modulation. Manual therapy activates afferent neuronal inputs that stimulate the central nervous system to inhibit pain through descending modulation. Like manual therapy, CPM inhibits pain through descending modulation. Continuous stimulation of central mechanisms through CPM should therefore alter pain processing and improve pain inhibition.

However, few studies have used CPM as an intervention, and none answer these research questions: 1) Does repeated exposure to conditioned pain modulation affect pain sensitivity? 2) Is analgesic efficacy of the nervous system predicted by the CPM effect? 3) Does CPM have therapeutic implications?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Not currently seeking treatment for pain past month;
  • between 18 - 75 years old.

排除标准

  • Participants will not be excluded based on race or gender but will be excluded if they meet any of the following
  • non-English speaking;
  • systemic medical condition is known to affect sensation (i.e., diabetes);
  • regular use of prescription pain medication to manage pain;
  • current or history of chronic pain condition;
  • currently using blood thinning medication;
  • any blood clotting disorder such as hemophilia;
  • any contraindication to the application of ice or cold packs, such as uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise;
  • involved in vigorous physical activities like heavy lifting, digging, aerobics or fast bicycling.

结局指标

主要结局

Conditioned Pain Modulation as an assessment

时间窗: Two weeks

Participants will receive a testing stimulus of pressure applied per ascending intensity at the web space of the foot until the pain reaches 40 out of 100, then discontinued. After testing the stimulus, Participants will receive a conditioning stimulus contact heat stimulus applied to the thenar of the left hand for 60 s at an intensity of 46.5 ◦C. Subjects will be asked to rate the heat pain during the four 60-second trials. Subjects will be instructed that they may remove their hand at any time if the heat is intolerable. After 60 seconds, the contact heat will be completely removed, and the testing stimulus will be re-applied to the web space of the dominant foot. Conditioned pain modulation will be calculated as the average pain ratings of the second testing stimulus series minus the average pain ratings of the first testing stimulus series. Negative numbers indicate efficient pain modulation

Expectations

时间窗: Two Weeks

Individuals will be asked what they expect exposure to the coldpressor task to do the amount of pressure needed to generate pain (see "Intervention" for the coldpressor task).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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