Acupuncture for Relieving Chronic Pelvic Pain

NCT03854188 | Withdrawn

• 1 other identifier: 201808791
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Pain

Keywords

acupuncture

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Measure pain score after treatment-1 month (GUPI)

  One month post treatment

• Measure pain score after treatment-1 month (BPI)

  One month post treatment

• Measure pain score after treatment-2 months (GUPI)

  Two months post treatment

• Measure pain score after treatment-2 months (BPI)

  Two months post treatment

• Measure pain score after treatment-3 months (GUPI)

  Three months post treatment

Study Arms (1)

Acupuncture treatment

EXPERIMENTAL

Patients diagnosed with chronic pelvic pain will be offered acupuncture treatment as an adjuvant therapy to standard of care treatment.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Use acupuncture therapy in the treatment of chronic pelvic pain.

Acupuncture treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Xu, MD: lead

Related Publications (6)

• 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.

  PMID: 14990428 BACKGROUND

• 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.

  PMID: 8598948 BACKGROUND

• 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.

  PMID: 24322588 BACKGROUND

• 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.

  PMID: 27764035 BACKGROUND

• 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.

  PMID: 29198932 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• William Xu, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Anesthesiologist

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 26, 2019
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
• Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal