An interventional study of Acupuncture in Pelvic Pain, sponsored by William Xu, MD. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by William Xu, MD · Not applicable, Interventional, and Treatment
Individuals with chronic pelvic pain will be identified, consented and enrolled in this study in which acupuncture will be offered in addition to current standards of care. The primary outcome will assess if there is a reduction of pain intensity from the baseline to 6 months as a result of treatment.
Chronic pelvic pain as defined by the American College of Obstetricians and Gynecologists is "noncyclic pain of 6 or more months duration that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back or the buttocks and is of sufficient severity to cause functional disability or lead to medical care". This has devastating consequences both monetarily as well as emotionally and can lead to opioid addiction, depression and even suicide.
Acupuncture has been used to treat pain in China for millenniums and was one of the more effective ways to treat pain before morphine was discovered. Acupuncture is feasible, economic and a safe way to treat chronic pain.
Patients with chronic pelvic pain will be identified and offered participation in the study. After the consent process is completed, patients will undergo a brief physical exam to rule out acute symptoms. The patient will be asked to complete a baseline pain inventory and genitourinary pain index survey before proceeding with acupuncture treatment. Qualified patients will be requested to accept acupuncture treatments twice weekly for 12 consecutive weeks. Each week the patient will be asked to report their current medications and changes in the dosage as well as their narcotic (opioid) doses and any changes in the dosages. Patients will be followed up monthly for up to 3 months after treatment completion by phone to record their pain inventory as well as their genitourinary pain index survey.
375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.
Browse Pelvic Pain studies →This is the only study on the registry with William Xu, MD as lead sponsor.
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Exclusion Criteria:
Patients diagnosed with chronic pelvic pain will be offered acupuncture treatment as an adjuvant therapy to standard of care treatment.
Procedure: Acupuncture
Use acupuncture therapy in the treatment of chronic pelvic pain.
Measure pelvic specific pain
Subjects will report baseline pain scores using the Genitourinary Pain Index (GUPI). The index is used to quantify the severity of pelvic pain experienced by the patient. It is a self-reporting condition specific questionnaire (gender specific) that is scored based on information provided by the patient. The scale is 0 to 5 with 0 indicating never experienced and 5 indicating being always present. The same index will be used at the end of treatment to determine the post-treatment scores and compared to baseline scores.
Time frame: Three months
Measure generalized body pain
Subjects will report initial baseline pain scores using the Brief Pain Inventory (BPI). The BPI assesses the severity of pain experienced by the patient and calculates pain's impact on daily functioning. It is self-reported and uses a numerical scale where 0 indicates no pain and 10 indicating pain as bad as the patient can image. The patient will report again using the BPI at the end of treatment and the values obtained will be compared to the baseline scores.
Time frame: Three months
Measure pain score after treatment-1 month (GUPI)
Subjects reported baseline pain scores using the Genitourinary Pain Index (GUPI). The index is used to quantify the severity of pelvic pain experienced by the patient. It is a self-reporting condition specific questionnaire (gender specific) that is scored based on information provided by the patient. The scale is 0 to 5 with 0 indicating never experienced and 5 indicating being always present. The same index will be used 1 month following the end of treatment and compared to baseline scores.
Time frame: One month post treatment
Measure pain score after treatment-1 month (BPI)
Subjects reported baseline pain scores using the Brief Pain Inventory (BPI). The BPI assesses the severity of pain experienced by the patient and calculates pain's impact on daily functioning. It is self-reported and uses a numerical scale where 0 indicates no pain and 10 indicating pain as bad as the patient can image. The BPI will be used 1 month following the end of treatment and compared to baseline scores.
Time frame: One month post treatment
Measure pain score after treatment-2 months (GUPI)
Subjects reported baseline pain scores using the Genitourinary Pain Index (GUPI). The index is used to quantify the severity of pelvic pain experienced by the patient. It is a self-reporting condition specific questionnaire (gender specific) that is scored based on information provided by the patient. The scale is 0 to 5 with 0 indicating never experienced and 5 indicating being always present. The same index will be used 2 months following the end of treatment and compared to baseline scores.
Time frame: Two months post treatment
Measure pain score after treatment-2 months (BPI)
Subjects reported baseline pain scores using the Brief Pain Inventory (BPI). The BPI assesses the severity of pain experienced by the patient and calculates pain's impact on daily functioning. It is self-reported and uses a numerical scale where 0 indicates no pain and 10 indicating pain as bad as the patient can image. The BPI will be used 2 months following the end of treatment and compared to baseline scores.
Time frame: Two months post treatment
Measure pain score after treatment-3 months (GUPI)
Subjects reported baseline pain scores using the Genitourinary Pain Index (GUPI). The index is used to quantify the severity of pelvic pain experienced by the patient. It is a self-reporting condition specific questionnaire (gender specific) that is scored based on information provided by the patient. The scale is 0 to 5 with 0 indicating never experienced and 5 indicating being always present. The same index will be used 3 months following the end of treatment and compared to baseline scores.
Time frame: Three months post treatment
Measure pain score after treatment-3 months (BPI)
Subjects reported baseline pain scores using the Brief Pain Inventory (BPI). The BPI assesses the severity of pain experienced by the patient and calculates pain's impact on daily functioning. It is self-reported and uses a numerical scale where 0 indicates no pain and 10 indicating pain as bad as the patient can image. The BPI will be used 2 months following the end of treatment and compared to baseline scores.
Time frame: Three months post treatment
No study locations are listed for this record.
Plan to share: Yes — All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Supporting information: Study protocol, Icf
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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