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
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 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. Pain outcomes will be assessed with Defense and Veterans Pain Rating Scale (DVPRS)
and Female Genitourinary Pain Index (GUPI). For subjects with a history of sexual trauma,
a sub analysis will assess symptom change before and after treatment with PTSD Checklist
for DSM-5 (PCL-5).
Visit 1 (week 0) (may be same day as screening visit) (20 minutes):
Visit 2 (week 4) (60 minutes) (In-Person):
Subjects will report which treatments they have received since the screening visit
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 Monthly to subjects with a history of sexual assault
The Dragons Script will be read to the subjects by the provider administering
treatment
Subjects will receive their initial Acupuncture treatment with Dragons
Visit 3 (week 5) (60 minutes) (In-Person):
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 Weekly to subjects with a history of sexual assault
The Dragons Script will be read to the subjects by the provider administering
treatment (visits 3-5 the subject can elect to read the script themselves).
Subjects will receive their second Acupuncture treatment with Dragons
Visit 4 (week 6) (60 minutes) (In-Person):
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 Weekly to subjects with a history of sexual assault
The Dragons Script will be read to the subjects by the provider administering
treatment (visits 3-5 the subject can elect to read the script themselves).
Subjects will receive their third Acupuncture treatment with Dragons
Visit 5 (week 7) (60 minutes) (In-Person):
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 Weekly to subjects with a history of sexual assault
The Dragons Script will be read to the subjects by the provider administering
treatment (visits 3-5 the subject can elect to read the script themselves).
Subjects will receive their fourth Acupuncture treatment with Dragons
Visit 6 (week 11) (60 minutes) May be done virtually: