Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388590
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-24
Brief Title:
Acupuncture for Chronic Pelvic Pain
Sponsor:
David Moss
Organization:
Mike OCallaghan Military Hospital
Study Overview
Official Title:
Acupuncture for Chronic Pelvic Pain
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Dragons protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault
This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain
This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain
Detailed Description:
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 Dragons 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 Dragons 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 Dragons 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 inclusionexclusion criteria via medical record review
Record all medications the subject is taking
Collect demographic information to include DoD ID age race assigned sex at birth military status active duty reserve retired separated or dependent history of sexual assault prior to onset of pelvic pain history of mental health diagnoses eg 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
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 to subjects with a history of sexual assault
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
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 Monthly to subjects with a history of sexual assault
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 Dragons 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 Dragons 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 inclusionexclusion criteria via medical record review
Record all medications the subject is taking
Collect demographic information to include DoD ID age race assigned sex at birth military status active duty reserve retired separated or dependent history of sexual assault prior to onset of pelvic pain history of mental health diagnoses eg 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
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 to subjects with a history of sexual assault
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
Administer DVPRS including supplemental quality of life questions
Administer GUPI
Administer PCL-5 Monthly to subjects with a history of sexual assault
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None