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临床试验/NCT06533345
NCT06533345招募中不适用

MERCI Chronic Pain Research Clinic (Medical Education and Research in Compassionate Integration/Intervention)

Edward Via Virginia College of Osteopathic Medicine1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Pain Intensity (NRS Pain Scale)

研究概览

简要总结

Studies estimate that 30% of people worldwide experience chronic pain. The mechanisms causing this pain can vary: a neuropathic offender, such as nerve compression; a structural offender, such as long-term effects of soft tissue damage and repair; or nociplastic, dysfunctional offenders, such as fibromyalgia. The type of pain experienced influences diagnostic and treatment choice. In theory, there's a significant blending of these pain types within individuals and across patients, leading many specialists to view pain classification as a spectrum. Multidisciplinary pain management (MPM) is a standard model for addressing and treating different mechanisms of chronic pain using multiple interventions from different disciplines. Although many clinics employing these strategies have resulted in positive and clinically effective outcomes, the creation and implementation of such facilities have not been widespread. With increasing focus on psychosocial factors that impact pain in conjunction with structural and biomechanical offenders, a need for a whole-person, integrated approach to chronic pain management is needed. We propose an observational study to gather data that will inform the design, implementation, and operation of such a chronic pain research clinic.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those experiencing chronic pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury).

排除标准

  • Those subjects seeking pharmaceutical intervention
  • Those whose myofascial pain is deemed functional (normal response to acute injury or ongoing pathology

研究组 & 干预措施

Osteopathic Manipulative Treatment

Experimental

Osteopathic Manipulative Treatment

干预措施: Osteopathic Manipulative Treatment (Other)

Dry Needling

Experimental

Dry Needling

干预措施: Dry Needling (Procedure)

Autonomic Recalibration

Experimental

Autonomic Recalibration

干预措施: Autonomic Recalibration (Other)

Nutrition

Experimental

Nutrition

干预措施: Nutrition (Behavioral)

Behavior Change Coaching

Experimental

Behavior Change Coaching

干预措施: Behavior Change Coaching (Behavioral)

Counseling Psychology

Experimental

Counseling Psychology

干预措施: Counseling Psychology (Behavioral)

Multiple

Experimental

Multiple

干预措施: Osteopathic Manipulative Treatment (Other)

Multiple

Experimental

Multiple

干预措施: Behavior Change Coaching (Behavioral)

Multiple

Experimental

Multiple

干预措施: Nutrition (Behavioral)

Multiple

Experimental

Multiple

干预措施: Autonomic Recalibration (Other)

Multiple

Experimental

Multiple

干预措施: Dry Needling (Procedure)

Multiple

Experimental

Multiple

干预措施: Counseling Psychology (Behavioral)

Multiple

Experimental

Multiple

干预措施: Multiple Treatments (Other)

结局指标

主要结局

Pain Intensity (NRS Pain Scale)

时间窗: Beginning of each Visit through study completion, an average (anticipated) of 6 months

0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine

PROMIS (Pain Interference, SF4a)

时间窗: Beginning of each Visit through study completion, an average (anticipated) of 6 months

Pain interference survey. Answers range from "Not at all" to "Very Much" when relating to the impact of pain on daily life.

Use of analgesics (QAQ-Quantitative Analgesic Questionnaire)

时间窗: Beginning of each Visit through study completion, an average (anticipated) of 6 months

Survey listing all medications taken for pain. All types are converted in equivalent doses of morphine and scored.

Human Flourishing (Secure Flourishing Index)

时间窗: Beginning of each Visit through study completion, an average (anticipated) of 6 months

Measure of Human Flourishing across 6 Domains. Scores range from 0-10 with lower scores indicating lower flourishing and higher scores indicating higher flourishing.

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

William Pearson

Discipline Chair for Anatomy

Edward Via Virginia College of Osteopathic Medicine

研究点 (1)

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