Acupuncture for Chronic Pelvic Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: David Moss
Disqualifiers: Severe mental disorders, Pregnancy, others
No Placebo Group
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.
12345Is 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.
13467How 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.
13489Eligibility 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
+1 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Mike O'Callaghan Military Medical CenterNellis Air Force Base, NV
Loading ...
Who Is Running the Clinical Trial?
David MossLead Sponsor
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]Chronic pelvic pain (CPP) affects 3-4% of women worldwide. Proven treatments for CPP are limited and unsatisfactory. The meridian balance method (BM) electroacupuncture (EA) treatment (BMEA + Traditional Chinese Medicine Health Consultation (TCM HC) may be effective for CPP. Previous EA studies have demonstrated an analgesic effect. Large-scale studies on acupuncture for other chronic pain conditions suggest that patient-healthcare provider interaction might play a role in pain reduction. We propose a pilot study to explore the effectiveness of the meridian BMEA treatment in managing women with CPP to inform a future large randomised controlled trial.
Electrodermal measures of Jing-Well points and their clinical relevance in endometriosis-related chronic pelvic pain. [2021]To determine whether electrodermal measures at Jing-Well acupuncture points, "indicator" points located at the tips of fingers and toes are associated with clinical measures in adolescent women with chronic pelvic pain.
[Acupuncture for chronic pelvic pain syndromes (CPPS) and its effect on cytokines in prostatic fluid]. [2011]To explore the effect of acupuncture on chronic pelvic pain syndromes (CPPS), and its therapeutic mechanism.
Research Trends of Acupuncture Therapy on Chronic Pelvic Pain Syndrome from 2000 to 2022: A Bibliometric Analysis. [2023]Acupuncture is considered an important means of analgesic, which has been widely used in chronic pelvic pain syndrome (CPPS) management and treatment in recent years, published a large number of related documents. However, the relevant literature in this field has not been summarized and quantitatively analyzed. Therefore, this study aims to analyze the hotspots and predicting future research trends of acupuncture on pelvic pain syndrome.
Acupuncture for chronic pelvic inflammatory disease: A systematic review protocol. [2021]Chronic pelvic inflammation disease (PID) is a difficult-to-treat gynecological disorder with complex etiologies. Acupuncture has been applied widely for treating chronic pelvic inflammation or chronic pelvic pain symptoms in China. The aim of this review is to undertake a systematic review to estimate the effectiveness and safety of acupuncture on chronic PID.
Effectiveness study of moxibustion on pain relief in primary dysmenorrhea: study protocol of a randomized controlled trial. [2021]Dysmenorrhea is a prevalent problem in menstruating women. As a nonpharmacologic and free of relevant side effects intervention, moxibustion is considered as a safe treatment and has long been recommended for dysmenorrhea in China. However, the exact effects of moxibustion in PD have not been fully understood. Therefore we designed this random clinical trial aiming to (1) investigate whether moxibustion is safe and effective for pain relief in primary dysmenorrhea when compared to conventional pain-killers and (2) assess the acceptability and side effects associated with moxibustion. The results of this trial will contribute to a better understanding of the different effects of moxibustion in pain relief in primary dysmenorrhea when compared to conventional pharmacologic pain treatment.
[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]To explore the possible mechanism of electroacupuncture (EA) underlying improvement of chronic pelvic pain syndrome (CPPS).
Acupuncture for Endometriosis: A Case Study. [2020]Background: Endometriosis is the cause of chronic pelvic pain in 70% of all chronic pelvic pain cases in women in the United States. Traditional Chinese Medicine may present either an adjunct or optional treatment for women with chronic pelvic pain due to endometriosis. Objective: To detail possible effects of Traditional Chinese Medicine on pelvic pain secondary to endometriosis through presentation of a single case. Design, Setting, Patient: A nulliparous 43-year-old woman presented with endometriosis and fibroids. The patient was treated twice weekly for a 6-month period in a Traditional Chinese Medicine clinic in Berkley, CA. Treatment included 6 months of acupuncture at the following points: CV 3, 4, and 5; ST 25 and 36; GV 20; LI 4; LV 3; KI 3; SP 6 and 9; and Zi Gong Xue and Ah Shi points along with 1 month of herbal treatment in the form of both tea and tea pills. Intervention: Acupuncture and herbal formulas. Main Outcome Measures: Decrease in pain level and symptoms measured by patient assessed value of pain through the Pain Quality Assessment Scale. Results: Patient overall disposition and pain level improved for a 6-month period. Conclusions: Acupuncture did have some positive effect on pain management.
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]Chronic pelvic pain (CPP) - defined as intermittent or constant pain in the lower abdomen or pelvis of at least 6 months' duration, not occurring exclusively with menstruation or intercourse and not associated with pregnancy - is estimated to affect 6-27% of women worldwide. In the United Kingdom, over 1 million women suffer from CPP, which has been highlighted as a key area of unmet need. Current medical treatments for CPP are often associated with unacceptable side effects. A specific style of acupuncture, the meridian balance method electro-acupuncture (BMEA) and traditional Chinese medicine health consultation (TCM HC (BMEA + TCM HC = BMEA treatment)), may be effective for CPP in women.