Acupuncture for Chronic Pelvic Pain

David Moss2 个研究点分布在 1 个国家目标入组 64 人开始时间: 2024年12月1日最近更新: 2026年4月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: David Moss
入组人数: 64
试验地点: 2
主要终点: Defense and Veterans Pain Rating Scale (DVPRS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain.

详细描述

The objective of this study is to determine if alternative pain management strategies, namely acupuncture, may help reduce intensity of female pelvic pain compared to other pain control modalities. This research study will focus specifically on the Dragon's protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault. The Dragons protocol consists of two parts, both completed at the same visit; external Dragons (needles are placed on the dorsal surface of the body) and internal Dragons (needles are placed on the ventral surface of the body). In Chinese Acupuncture theory, external dragons represent the traumatic events that happen in our life and the internal dragons represent dragons that live in the body and fight off the external dragons. It is used to treat post-traumatic stress. During external dragons the patient thinks about prior trauma (let the external dragons in) then during the second phase of treatment the internal dragons fight off the external dragons. From a western neurobiology perspective, clinical experience suggests that patients with post-traumatic stress have memories stored in the limbic system, that when triggered, activate the sympathetic nervous system. Dragons allows the brain to "reprocess" these memories so that triggers do not activate a sympathetic response in the patient. The mechanism is unknown, but the investigators theorize it may be due to vagal stimulation from the needles while the patient "relives" the traumatic event, thus experiencing the event in a parasympathetic state. This intervention will be compared to other treatment modalities such as pelvic floor physical therapy, non-steroidal anti-inflammatories, Osteopathic Manipulative Medicine, or any other usual means to achieve pain control offered by their providers.

The investigators will measure pre-procedure and post-procedure pain levels using the standard military Defense and Veterans Pain Rating Scale (DVPRS) in addition to a literature-based pelvic pain questionnaire, the Female Genitourinary Pain Index (GUPI). In addition to the pain index scales, patients with a history of sexual trauma will receive the PTSD Checklist for DSM-5 (PCL-5) which is a standardized measurement tool for assessing for PTSD. The provided acupuncture intervention, Dragon's, is classically used to treat both physical and emotional pain. Therefore, a sub-analysis will be performed to evaluate improvement in PTSD symptoms in those with a history of sexual assault and trauma.

The hypothesis of this study is that acupuncture with Dragon's will reduce chronic pelvic pain in females with and without a history of sexual trauma as it is designed to treat both physical and emotional pain. This is a relatively safe, effective, and non-invasive treatment strategy that could be offered as an alternative means of pain control when traditional modalities are ineffective.

Screening visit (30 minutes)

Obtain and document signed Informed Consent document and HIPAA Authorization
Verify subject eligibility based on inclusion/exclusion criteria via medical record review
Record all medications the subject is taking
Collect demographic information to include DoD ID, age, race, gender, military status (active duty, reserve, retired, separated or dependent), history of sexual assault prior to onset of pelvic pain, history of mental health diagnoses (e.g. anxiety, depression, PTSD), prior treatments used to treat pelvic pain

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 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
•Inclusion Criteria:
•Active Duty and DoD Female Beneficiaries (i.e. former military, spouse, dependent) aged 21-65 with chronic pelvic pain
•Have negative laparoscopic findings for endometriosis

排除标准

•Severe mental health disorders to include any disorder with psychotic features (e.g schizophrenia, bipolar, schizoaffective disorder)
•Pelvic pain as a result of severe physical trauma (excluding sexual assault) such as traumatic childbirth, pelvic fractures or any other trauma as determined by the PI or AI.
•Pregnancy

研究组 & 干预措施

Patient Cohort: Control

Experimental

Patient sample will be both control and treatment groups. Individuals will not be divided into distinct groups. Patients will serve as their own controls. Control patients will be participating in standard of care therapies including physical therapy, psychotherapy, behavioral health, typical primary care management, etc. as deemed appropriate by the primary care provider for 4 weeks prior to study intervention. The same patients will then crossover and be re-evaluated and will be offered Acupuncture with Dragon technique (see attachment Protocol for Needle Insertion) as a means of pain control once per week for 4 weeks.

干预措施: Standard of Care (Other)

Patient Cohort: Intervention

Experimental

干预措施: Dragons (Other)