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Pelvic PainNCT03854188

Acupuncture for Relieving Chronic Pelvic Pain

A study testing Acupuncture in people with Pelvic Pain, run by William Xu, MD.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pelvic Pain
What is being tested?
Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • Skin infections or lesions
  • Severe COPD
  • Neuropathy
  • Previous stroke
  • Paralysis
  • Needle phobia

About this study

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.

Read the 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.

Conditions
Pelvic Pain
Being tested
Acupuncture
Keywords
acupuncture
Medical subject headings
Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    Use acupuncture therapy in the treatment of chronic pelvic pain.

Study groups in NCT03854188
Study groupRoleWhat they receive
Acupuncture treatmentExperimentalPatients diagnosed with chronic pelvic pain will be offered acupuncture treatment as an adjuvant therapy to standard of care treatment.
Receives: Procedure: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three months

  2. 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.

    Measured: Three months

Secondary outcomes (6)

  1. 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.

    Measured: One month post treatment

  2. 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.

    Measured: One month post treatment

  3. 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.

    Measured: Two months post treatment

  4. 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.

    Measured: Two months post treatment

  5. 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.

    Measured: Three months post treatment

  6. 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.

    Measured: Three months post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2019
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Why it stopped: Principle investigator is leaving institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03854188
Sponsor's protocol ID
201808791
Status last verified
Mar 2021
First submitted
5 Feb 2019
Last updated
5 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 14990428

  • 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.

    PubMed 8598948

  • 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.

    PubMed 24322588

  • 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.

    PubMed 27764035

  • 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.

    PubMed 29198932

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

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Pelvic Pain, run by William Xu, MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure pelvic specific pain (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03854188, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.

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