Recruiting

Acupuncture

Sponsor:

David Moss

Code:

NCT06388590

Conditions

Pelvic Pain

Acupuncture

Gynecology

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Dragons

Standard of Care

Study Details

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

Study ID

NCT06388590

Start date

Dec 1, 2024

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

\*\*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

Exclusion Criteria:

  • 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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patient Cohort: Control

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.

experimental: Patient Cohort: Intervention

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.

Interventions

Dragons

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

Standard of Care

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.

Primary outcome measure

  • Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Visit 1 (Week 0) ]
  • Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Visit 2 (Week 4) ]
  • Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Visit 3 (Week 5) ]
  • Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Visit 4 (Week 6) ]
  • Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Visit 5 (Week 7) ]
  • Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Visit 6 (Week 11) ]
  • Female Genitourinary Pain Index (GUPI) [ Time Frame: Visit 1 (Week 0) ]
  • Female Genitourinary Pain Index (GUPI) [ Time Frame: Visit 2 (Week 4) ]
  • Female Genitourinary Pain Index (GUPI) [ Time Frame: Visit 3 (Week 5) ]
  • Female Genitourinary Pain Index (GUPI) [ Time Frame: Visit 4 (Week 6) ]
  • Female Genitourinary Pain Index (GUPI) [ Time Frame: Visit 5 (Week 7) ]
  • Female Genitourinary Pain Index (GUPI) [ Time Frame: Visit 6 (Week 11) ]

Central Contacts and Locations

Central contacts

Amanda Crawford, MSHS

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

Locations

Mike O'Callaghan Military Medical Center

Recruiting

Nellis Air Force Base, Nevada, United States, 89191

Contacts

Amanda J Crawford, MSHS

702-653-3583amanda.j.crawford.ctr@health.mil

More Information

Sponsor

David Moss

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • integrative medicine
  • acupuncture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Moss on 2026-04-14.