Pelvic Pain Clinical Trial
Official title:
Acupuncture for Chronic Pelvic Pain
NCT number | NCT06388590 |
Other study ID # | MOMMC.2024.0029 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | April 2026 |
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | April 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 65 Years |
Eligibility | **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 - Females or individuals not identifying as female with female organs/female genotype, as above who also either do or do not have a history of sexual assault - Have negative laparoscopic findings for endometriosis Exclusion Criteria: - Individuals identifying as female whose gender at birth was not female - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mike O'Callaghan Military Medical Center | Nellis Air Force Base | Nevada |
Lead Sponsor | Collaborator |
---|---|
David Moss |
United States,
Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | PTSD Checklist for DSM-5 (PCL-5) | Will be administered to subjects with history of sexual trauma.
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change. |
Visit 1 (Week 0) | |
Secondary | PTSD Checklist for DSM-5 (PCL-5) | Will be administered to subjects with history of sexual trauma.
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change. |
Visit 2 (Week 4) | |
Secondary | PTSD Checklist for DSM-5 (PCL-5) | Will be administered to subjects with history of sexual trauma.
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change. |
Visit 3 (Week 5) | |
Secondary | PTSD Checklist for DSM-5 (PCL-5) | Will be administered to subjects with history of sexual trauma.
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change. |
Visit 4 (Week 6) | |
Secondary | PTSD Checklist for DSM-5 (PCL-5) | Will be administered to subjects with history of sexual trauma.
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change. |
Visit 5 (Week 7) | |
Secondary | PTSD Checklist for DSM-5 (PCL-5) | Will be administered to subjects with history of sexual trauma.
PCL-5 is a 20-item self-reporting measure of PTSD rating how the respondent has been bothered by PTSD symptoms over the past month using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Responses are summed to a total score with higher scores indicate greater PTSD symptom severity. A total symptom severity score (range 0 - 80) can be obtained by summing the scores for each of the 20 items. Research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD. A 5 - 10 point change represents reliable change (i.e., change not due to chance) and a 10 - 20 point change represents clinically significant change. |
Visit 6 (Week 11) |
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