64 Participants Needed

Acupuncture for Chronic Pelvic Pain

AC
Overseen ByAmanda Crawford, MSHS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: David Moss
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Dragon's Protocol of Acupuncture for chronic pelvic pain?

Research suggests that acupuncture, including methods like the meridian balance method electroacupuncture, may help reduce chronic pelvic pain by providing pain relief. Studies have shown acupuncture's potential in managing pain through patient-healthcare provider interaction and its analgesic (pain-relieving) effects.12345

Is acupuncture safe for treating chronic pelvic pain?

Acupuncture is generally considered safe for treating chronic pelvic pain, as large-scale studies on acupuncture for other chronic pain conditions suggest it is a safe treatment option.13467

How is the Dragon's Protocol of Acupuncture treatment different from other treatments for chronic pelvic pain?

The Dragon's Protocol of Acupuncture is unique because it uses specific acupuncture points and techniques that may influence cytokines (proteins involved in inflammation) in prostatic fluid, potentially offering a novel mechanism for pain relief in chronic pelvic pain. Unlike many standard treatments, acupuncture is a non-drug therapy that may have fewer side effects.13489

Eligibility Criteria

This trial is for women experiencing chronic pelvic pain not caused by endometriosis. It's open to those with or without a history of sexual assault. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

I am female or have female organs/genotype, regardless of my sexual assault history.
Have negative laparoscopic findings for endometriosis
I am a woman aged 21-65, connected to the military, and suffer from chronic pelvic pain.

Exclusion Criteria

I identify as female but was not assigned female at birth.
Severe mental health disorders to include any disorder with psychotic features (e.g schizophrenia, bipolar, schizoaffective disorder)
Pregnancy
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

30 minutes
1 visit (in-person)

Control Phase

Participants receive standard of care therapies including physical therapy, psychotherapy, behavioral health, and typical primary care management for 4 weeks prior to study intervention.

4 weeks

Treatment

Participants receive Acupuncture with Dragon technique as a means of pain control once per week for 4 weeks.

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments using DVPRS, GUPI, and PCL-5 for those with a history of sexual trauma.

4 weeks
1 visit (may be virtual)

Treatment Details

Interventions

  • Dragon's Protocol of Acupuncture
Trial Overview The study tests the Dragon's protocol acupuncture against standard pain management strategies to see if it can reduce chronic pelvic pain in women more effectively.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Patient Cohort: InterventionExperimental Treatment1 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.
Group II: Patient Cohort: ControlExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Moss

Lead Sponsor

Trials
6
Recruited
830+

Findings from Research

A pilot study is being conducted to evaluate the effectiveness of the meridian balance method electroacupuncture (BMEA) combined with Traditional Chinese Medicine Health Consultation (TCM HC) for managing chronic pelvic pain (CPP) in women, with a target recruitment of 30 participants.
The study aims to assess recruitment and retention rates, as well as the effectiveness and acceptability of the treatment methods and assessment tools, which will inform a future larger randomized controlled trial.
The BMEA study: the impact of meridian balanced method electroacupuncture on women with chronic pelvic pain-a three-arm randomised controlled pilot study using a mixed-methods approach.Chong, OT., Critchley, HO., Horne, AW., et al.[2022]
In a study involving 14 adolescent women with endometriosis and chronic pelvic pain, those receiving active acupuncture showed significant improvements in electrodermal measures, indicating a potential link between these measures and clinical outcomes.
Electrodermal asymmetry was notably associated with reductions in pelvic pain and improvements in quality of life, suggesting that these measures could be useful indicators of treatment efficacy in acupuncture for chronic pelvic pain.
Electrodermal measures of Jing-Well points and their clinical relevance in endometriosis-related chronic pelvic pain.Ahn, AC., Schnyer, R., Conboy, L., et al.[2021]
In a study of 47 patients with chronic pelvic pain syndromes (CPPS), electroacupuncture significantly reduced pain scores, indicating its effectiveness as a treatment option (total effective rate of 89.4%).
The treatment also lowered inflammatory markers IL-8 and TNF-alpha, suggesting that acupuncture may alleviate pain by reducing inflammation and modulating immune responses.
[Acupuncture for chronic pelvic pain syndromes (CPPS) and its effect on cytokines in prostatic fluid].Yuan, SY., Qin, Z., Liu, DS., et al.[2011]

References

The BMEA study: the impact of meridian balanced method electroacupuncture on women with chronic pelvic pain-a three-arm randomised controlled pilot study using a mixed-methods approach. [2022]
Electrodermal measures of Jing-Well points and their clinical relevance in endometriosis-related chronic pelvic pain. [2021]
[Acupuncture for chronic pelvic pain syndromes (CPPS) and its effect on cytokines in prostatic fluid]. [2011]
Research Trends of Acupuncture Therapy on Chronic Pelvic Pain Syndrome from 2000 to 2022: A Bibliometric Analysis. [2023]
Acupuncture for chronic pelvic inflammatory disease: A systematic review protocol. [2021]
Effectiveness study of moxibustion on pain relief in primary dysmenorrhea: study protocol of a randomized controlled trial. [2021]
[Effect of electroacupuncture on pain threshold and expression of pain-related factors cyclooxygenase-2, prostaglandin E2 and β-endorphin in rats with chronic pelvic pain syndrome]. [2022]
Acupuncture for Endometriosis: A Case Study. [2020]
Chronic pelvic pain in women: an embedded qualitative study to evaluate the perceived benefits of the meridian balance method electro-acupuncture treatment, health consultation and National Health Service standard care. [2022]
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