Acupuncture for Relieving Chronic Pelvic Pain

Pelvic Pain Clinical Trial

Official title:

Acupuncture for Relieving Chronic Pelvic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03854188
• Other study ID #: 201808791
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

Procedure:
• Acupuncture
Use acupuncture therapy in the treatment of chronic pelvic pain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
William Xu, MD

References & Publications (6)

ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin No. 51. Chronic pelvic pain. Obstet Gynecol. 2004 Mar;103(3):589-605. Review. — View Citation

Ernst, E., White A. Acupuncture - A Scientific Appraisal. ISBN#978-0-7506-4163-0

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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three months
Primary	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.	Three months
Secondary	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.	One month post treatment
Secondary	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.	One month post treatment
Secondary	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.	Two months post treatment
Secondary	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.	Two months post treatment
Secondary	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.	Three months post treatment
Secondary	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.	Three months post treatment