Clinical trial NCT03854188: Acupuncture for Relieving Chronic Pelvic Pain
Official title: Acupuncture for Relieving Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pelvic Pain
Keywords: acupuncture
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Chronic pelvic pain persisting for at least 6 months
* English speaking
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent
* Pregnant
* Prisoners
* Morbid obesity (BMI \>40, or \> 36 associated with hypertension and diabetes)
* Severe cardiac disease
* Active chemotherapy or radiation therapy
* Skin infections or lesions
* Severe COPD
* Neuropathy
* Previous stroke
* Paralysis
* Needle phobia

Primary outcomes:
measure: Measure pelvic specific pain
timeFrame: Three months
measure: Measure generalized body pain
timeFrame: Three months
Secondary outcomes:
measure: Measure pain score after treatment-1 month (GUPI)
timeFrame: One month post treatment
measure: Measure pain score after treatment-1 month (BPI)
timeFrame: One month post treatment
measure: Measure pain score after treatment-2 months (GUPI)
timeFrame: Two months post treatment
measure: Measure pain score after treatment-2 months (BPI)
timeFrame: Two months post treatment
measure: Measure pain score after treatment-3 months (GUPI)
timeFrame: Three months post treatment
measure: Measure pain score after treatment-3 months (BPI)
timeFrame: Three months post treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: William Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin No. 51. Chronic pelvic pain. Obstet Gynecol. 2004 Mar;103(3):589-605. No abstract available.
citation: Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
citation: Zhang R, Lao L, Ren K, Berman BM. Mechanisms of acupuncture-electroacupuncture on persistent pain. Anesthesiology. 2014 Feb;120(2):482-503. doi: 10.1097/ALN.0000000000000101.
citation: MacPherson H, Vertosick EA, Foster NE, Lewith G, Linde K, Sherman KJ, Witt CM, Vickers AJ; Acupuncture Trialists' Collaboration. The persistence of the effects of acupuncture after a course of treatment: a meta-analysis of patients with chronic pain. Pain. 2017 May;158(5):784-793. doi: 10.1097/j.pain.0000000000000747.
citation: Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
citation: Ernst, E., White A. Acupuncture - A Scientific Appraisal. ISBN#978-0-7506-4163-0