Acupuncture for Chronic Pelvic Pain

NCT06388590 | Recruiting

• 1 other identifier: MOMMC.2024.0029
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Pain; Acupuncture; Gynecology

Keywords

integrative medicine; acupuncture

Outcome Measures

Primary Outcomes (12)

• Defense and Veterans Pain Rating Scale (DVPRS)

  The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 1 (Week 0)

• Defense and Veterans Pain Rating Scale (DVPRS)

  The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 2 (Week 4)

• Defense and Veterans Pain Rating Scale (DVPRS)

  The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 3 (Week 5)

• Defense and Veterans Pain Rating Scale (DVPRS)

  The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 4 (Week 6)

• Defense and Veterans Pain Rating Scale (DVPRS)

  The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 5 (Week 7)

• Defense and Veterans Pain Rating Scale (DVPRS)

  The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 6 (Week 11)

• Female Genitourinary Pain Index (GUPI)

  GUPI is a validated instrument to assess the degree of symptoms in both men and women with genitourinary pain complaints. It has a range of 0 to 45 and has also demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 1 (Week 0)

• Female Genitourinary Pain Index (GUPI)

  GUPI is a validated instrument to assess the degree of symptoms in both men and women with genitourinary pain complaints. It has a range of 0 to 45 and has also demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 2 (Week 4)

• Female Genitourinary Pain Index (GUPI)

  GUPI is a validated instrument to assess the degree of symptoms in both men and women with genitourinary pain complaints. It has a range of 0 to 45 and has also demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 3 (Week 5)

• Female Genitourinary Pain Index (GUPI)

  GUPI is a validated instrument to assess the degree of symptoms in both men and women with genitourinary pain complaints. It has a range of 0 to 45 and has also demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 4 (Week 6)

• Female Genitourinary Pain Index (GUPI)

  GUPI is a validated instrument to assess the degree of symptoms in both men and women with genitourinary pain complaints. It has a range of 0 to 45 and has also demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 5 (Week 7)

• Female Genitourinary Pain Index (GUPI)

  GUPI is a validated instrument to assess the degree of symptoms in both men and women with genitourinary pain complaints. It has a range of 0 to 45 and has also demonstrated linear scale qualities allowing parametric methods to be used.

  Visit 6 (Week 11)

Secondary Outcomes (6)

• PTSD Checklist for DSM-5 (PCL-5)

  Visit 1 (Week 0)

• PTSD Checklist for DSM-5 (PCL-5)

  Visit 2 (Week 4)

• PTSD Checklist for DSM-5 (PCL-5)

  Visit 3 (Week 5)

• PTSD Checklist for DSM-5 (PCL-5)

  Visit 4 (Week 6)

• PTSD Checklist for DSM-5 (PCL-5)

  Visit 5 (Week 7)

Study Arms (2)

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.

Other: Standard of Care

Patient Cohort: Intervention

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.

Other: Dragons

Interventions

Dragons OTHER

The Dragons Script will be read to the subjects by the provider administering treatment. Subjects will receive their Acupuncture treatment with Dragons protocol.

Patient Cohort: Intervention

Standard of Care OTHER

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.

Patient Cohort: Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Moss: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

RECRUITING

Related Publications (4)

• Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.

  PMID: 24658485 BACKGROUND

• Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.

  PMID: 34128995 BACKGROUND

• Li PS, Peng XM, Niu XX, Xu L, Hung Yu Ng E, Wang CC, Dai JF, Lu J, Liang RN. Efficacy of acupuncture for endometriosis-associated pain: a multicenter randomized single-blind placebo-controlled trial. Fertil Steril. 2023 May;119(5):815-823. doi: 10.1016/j.fertnstert.2023.01.034. Epub 2023 Jan 27.

  PMID: 36716811 BACKGROUND

• Zhu X, Hamilton KD, McNicol ED. Acupuncture for pain in endometriosis. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD007864. doi: 10.1002/14651858.CD007864.pub2.

  PMID: 21901713 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Amanda Crawford, MSHS

CONTACT

7026533583; amanda.j.crawford.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator/MD

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)