Acupuncture for Chronic Pelvic Pain

Overseen By Amanda Crawford, MSHS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: David Moss

Disqualifiers: Severe mental disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can reduce chronic pelvic pain in women, particularly those without endometriosis. The researchers will use a specific acupuncture method called the Dragon's Protocol of Acupuncture to determine its effectiveness compared to usual pain treatments. Participants will first receive standard care, followed by acupuncture, to compare results. Women who are active duty or Department of Defense beneficiaries, have tested negative for endometriosis, and can receive care at Nellis Air Force Base may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore alternative pain management options.

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 prior data suggests that the Dragon's Protocol of Acupuncture is safe for managing chronic pelvic pain?

Research has shown that acupuncture, including the Dragon's Protocol, is generally safe for treating chronic pelvic pain. Large studies on acupuncture for various types of chronic pain suggest it is well-tolerated. As a minimally invasive procedure, acupuncture does not involve major surgery or deep insertion into the body, reducing its risk. Additionally, acupuncture is considered affordable and has effectively relieved pain for many years.

Overall, acupuncture, including the Dragon's Protocol, is viewed as a low-risk option for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dragon's Protocol of Acupuncture for chronic pelvic pain because it offers a unique approach compared to standard treatments like physical therapy, psychotherapy, and medication. Unlike these conventional methods, which primarily focus on managing symptoms, this protocol uses a specific acupuncture technique that targets pain relief through precise needle insertion. The crossover design of the trial, where patients act as their own controls, also allows for a direct comparison of the effects of acupuncture against standard care, potentially demonstrating its effectiveness more clearly. This novel approach might offer a complementary or alternative option for those who continue to experience pain despite standard treatments.

What evidence suggests that the Dragon's Protocol of Acupuncture is effective for chronic pelvic pain?

Research has shown that acupuncture can help reduce chronic pelvic pain. Studies have found that acupuncture treatments, such as the Dragon's Protocol, can relieve chronic pelvic pain and similar conditions. For example, acupuncture has been beneficial for chronic prostatitis, which shares symptoms with chronic pelvic pain syndrome. This suggests that acupuncture might also help with pelvic pain not caused by endometriosis. Overall, evidence supports acupuncture as a promising option for managing chronic pelvic pain in women.

In this trial, participants will first receive standard care therapies, such as physical therapy and psychotherapy, for four weeks. They will then crossover to receive acupuncture using the Dragon's Protocol once per week for four weeks, allowing them to serve as their own controls. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Patient Cohort: Intervention Experimental Treatment 1 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: Control Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

David Moss

Lead Sponsor

Trials

6

Recruited

830+

Published Research Related to This Trial

This clinical trial aims to evaluate the safety and effectiveness of moxibustion, a nonpharmacologic treatment, for relieving pain in primary dysmenorrhea compared to conventional painkillers.

The study will also assess the acceptability and side effects of moxibustion, contributing to a better understanding of its role in managing menstrual pain without the side effects associated with traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness study of moxibustion on pain relief in primary dysmenorrhea: study protocol of a randomized controlled trial. Yang, J., Chen, J., Lao, L., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Electroacupuncture (EA) significantly alleviated pain in a rat model of chronic pelvic pain syndrome (CPPS) by increasing mechanical and heat pain thresholds after treatment, indicating its potential efficacy as a pain management strategy.

The mechanism of EA's effectiveness appears to involve the down-regulation of inflammatory markers COX-2 and PGE2, along with the up-regulation of the pain-relieving peptide β-endorphin, suggesting a biochemical pathway through which EA exerts its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]. Wu, XL., Li, N., Xu, C., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acupuncture for chronic pelvic pain syndromes (CPPS) and its effect on cytokines in prostatic fluid]. Yuan, SY., Qin, Z., Liu, DS., et al.[2011]

A systematic review of 173 publications from 2000 to 2022 indicates that acupuncture is increasingly recognized as a valuable treatment for chronic pelvic pain syndrome (CPPS), with a growing number of studies published over time.

Future research will likely focus on understanding the mechanisms of acupuncture's effects on CPPS, as well as optimizing treatment parameters like electro-acupuncture, stimulation frequency, and duration, while emphasizing the need for more high-quality clinical trials to confirm its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Trends of Acupuncture Therapy on Chronic Pelvic Pain Syndrome from 2000 to 2022: A Bibliometric Analysis. Hu, J., Xiao, Y., Jiang, G., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A 43-year-old woman with endometriosis experienced significant improvement in chronic pelvic pain after receiving Traditional Chinese Medicine treatments, including acupuncture and herbal remedies, over a 6-month period.

The acupuncture treatment targeted specific points and resulted in a measurable decrease in pain levels, suggesting that Traditional Chinese Medicine may be a beneficial adjunct therapy for managing endometriosis-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for Endometriosis: A Case Study. Payne, JA.[2020]

Women with chronic pelvic pain (CPP) reported significant pain reduction and improved well-being after receiving the meridian balance method electro-acupuncture (BMEA) and traditional Chinese medicine health consultation (TCM HC), highlighting their potential as effective treatments.

In contrast, participants receiving standard care from the National Health Service (NHS SC) expressed dissatisfaction with medication side effects and a lack of effective treatment options, indicating a need for alternative therapies like BMEA and TCM HC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chong, OT., Critchley, HO., Horne, AW., et al.[2022]

This systematic review aims to evaluate the effectiveness and safety of acupuncture for treating chronic pelvic inflammation disease (PID), a challenging gynecological condition, by analyzing randomized controlled trials up to October 2018.

The primary outcomes will focus on improvement rates and pain relief, while secondary outcomes will assess recurrence rates and potential side effects, ensuring a comprehensive understanding of acupuncture's impact on chronic PID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for chronic pelvic inflammatory disease: A systematic review protocol. Cheng, Y., Yuan, Y., Jin, Y., et al.[2021]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06388590/acupuncture-for-chronic-pelvic-pain

Acupuncture for Chronic Pelvic Pain 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 ...

2. withpower.com withpower.com/trial/phase-acupuncture-3-2024-96cc4

Acupuncture for Chronic Pelvic Pain 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10695139/

Research Trends of Acupuncture Therapy on Chronic Pelvic ... The results showed that acupuncture showed satisfactory efficacy and lasting benefits to chronic prostatitis/chronic pelvic pain syndrome. This ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666168322021267

Pelvic Pain Acupuncture for Chronic Prostatitis ... Our previous studies found that current evidence supports acupuncture as an effective treatment for releasing the symptom of CP/CPPS with long-term effects, ...

5. dovepress.com dovepress.com/efficacy-of-different-acupuncture-therapies-for-chronic-prostatitischr-peer-reviewed-fulltext-article-JPR

Efficacy of Different Acupuncture Therapies for Chronic ... Acupuncture therapies, especially long-needle acupuncture, are more effective than UT for CP/CPPS, providing comprehensive symptom relief, pain reduction, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6180968/

Acupuncture Treatment for Chronic Pelvic Pain in Women Acupuncture has long been used and is effective in relieving pain and is also minimally invasive, inexpensive, and safe [8, 9]. Acupuncture used ...