Examining Osteopathic Manipulation on Making a Neuropsychological Brain of Difference in Adults With Pain: A BOD Study Protocol and Rationale for a New Approach
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:
- To describe the neuropsychological (NP) characteristics of adults with pain within an osteopathic and allopathic setting
- To correlate NP with clinical outcomes (pain severity, number/location of osteopathic lesions)
- To determine if OMT is associated with improved NP function.
- To use saliva to measure cytokine concentration of IL-1β,IL-6, IL-8, TNF-α
- 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
- 否
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
Mireille Rizkalla
Associate Professor
Midwestern University
