- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03854188
Acupuncture for Relieving Chronic Pelvic Pain
Study Overview
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupuncture treatment
Patients diagnosed with chronic pelvic pain will be offered acupuncture treatment as an adjuvant therapy to standard of care treatment.
|
Use acupuncture therapy in the treatment of chronic pelvic pain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure pelvic specific pain
Time Frame: Three months
|
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
Time Frame: Three months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure pain score after treatment-1 month (GUPI)
Time Frame: One month post treatment
|
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
|
Measure pain score after treatment-1 month (BPI)
Time Frame: One month post treatment
|
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
|
Measure pain score after treatment-2 months (GUPI)
Time Frame: Two months post treatment
|
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
|
Measure pain score after treatment-2 months (BPI)
Time Frame: Two months post treatment
|
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
|
Measure pain score after treatment-3 months (GUPI)
Time Frame: Three months post treatment
|
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
|
Measure pain score after treatment-3 months (BPI)
Time Frame: Three months post treatment
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Xu, MD, University of Iowa
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Ernst, E., White A. Acupuncture - A Scientific Appraisal. ISBN#978-0-7506-4163-0
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201808791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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