跳至主要内容
临床试验/NCT04058431
NCT04058431进行中(未招募)不适用

Examining Osteopathic Manipulation on Making a Neuropsychological Brain of Difference in Adults With Pain: A BOD Study Protocol and Rationale for a New Approach

Midwestern University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
2
主要终点
neuropsychology change

研究概览

简要总结

Patients with pain commonly experience cognitive impairment. While symptoms of pain are effectively treated with osteopathic manipulative treatment (OMT), the cognitive piece is vastly ignored. Pain-induced cognitive dysfunction can be severe and is particularly apparent in working memory and attention. There is good reason to also expect cognitive responsiveness to OMT. Previous research has already reported related psychiatric outcomes, including relief from stress, self-perception and anxiety, suggesting that OMT may produce more global effects on cortical processing than currently thought.

详细描述

Patients with pain commonly experience cognitive impairment. While symptoms of pain are effectively treated with osteopathic manipulative treatment (OMT), the cognitive piece is vastly ignored. Previous research has already reported related psychiatric outcomes, including relief from stress, self-perception and anxiety, suggesting that OMT may produce more global effects on cortical processing than currently thought. The current study is designed to extend previous research in several ways:

  1. To describe the neuropsychological (NP) characteristics of adults with pain within an osteopathic and allopathic setting
  2. To correlate NP with clinical outcomes (pain severity, number/location of osteopathic lesions)
  3. To determine if OMT is associated with improved NP function.
  4. To use saliva to measure cytokine concentration of IL-1β,IL-6, IL-8, TNF-α
  5. To correlate cytokine concentrations with clinical outcomes (pain severity, number/location of osteopathic lesions, NP)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 40 years of age or older;
  • seeking treatment for acute or chronic pain (neck, thoracic, shoulder, back)
  • gives a positive response to the item, "Have you had thinking problems because of your pain?";
  • agree to forego extra-trial manipulation (e.g., massage, chiropractic, physical therapy);
  • Score > 23 on the Telephone Interview for Cognitive Status;
  • written informed consent.

排除标准

  • recent (< 2 month) or planned surgery within the duration of the study;
  • use of medication that could interfere with cytokine measurements;
  • recent (< 2 month) changes to psychotropic medication within the duration of the study;
  • history of manipulation within the past six months.
  • diagnosed neurocognitive disorders;
  • contraindication to receiving OMT.

结局指标

主要结局

neuropsychology change

时间窗: baseline, week 8, week 12

standardized assessment battery

pain scale change

时间窗: baseline, week 8, week 12

1-10

inflammatory markers change

时间窗: baseline, week 8, week 12

cortisol

inflammatory marker

时间窗: baseline, week 8, week 12

TNF Alpha

Inflammatory marker

时间窗: baseline, week 8, week 12

IL 6

次要结局

未报告次要终点

研究者

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

Mireille Rizkalla

Associate Professor

Midwestern University

研究点 (2)

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