Ear Electro-stimulation for Chronic Pelvic Pain (RAVANS)

April 28, 2011 updated by: Brigham and Women's Hospital
The Brigham and Women's Pain Management Center is conducting a research study for chronic pelvic pain patients due to endometriosis. The study will assess the effect of electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking opioid medication (such as morphine or oxycodone). The study will require two visits, each lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center, 850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or ccahalan1@partners.org if interested.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Brigham and Women's Pain Management Center is conducting a research study for chronic pelvic pain patients due to endometriosis. The study will assess the effect of electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking opioid medication (such as morphine or oxycodone). The study will require two visits, each lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center, 850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or ccahalan1@partners.org if interested.

Vitaly Napadow, Ph.D., Lic.Ac. Assistant Professor Dept. of Radiology, Massachusetts General Hospital, Harvard Medical School

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female volunteers between 21 and 64 years of age with chronic pelvic pain for more than six months by self report. Six months of chronic pain is the criteria most often used in CPP research.
  • CPP diagnoses will include endometriosis pain.
  • Average pain intensity of ≥4 on a scale from 0 to 10, because <4 is considered a level with acceptable pain and function
  • At least an 8th grade English-reading level; English can be a second language provided that the subjects feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

  • Any interventional procedure for CPP two weeks prior to the study or during the two-week study period, such as lumbar epidural steroids, nerve root blocks, etc.
  • Any etiology for CPP due to a known local somatic lesion for the pain (e.g. fibroids etc.) documented by the patient's gynecologist, surgery and/or imaging. We wish to focus on functional CPP, which may be more amenable to RAVANS due to the systemic nature of VNS.
  • Opioid usage, either oral or intrathecal.
  • Surgical therapy in the previous 12 weeks, the intent to undergo surgery during the study period, or any clinically unstable systemic illness that is judged to interfere with the trial.
  • Non-ambulatory status
  • History of cardiac or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
  • An inability to complete questionnaires accurately.
  • Cancer or other malignant disease, except carcinoma in situ of the skin
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Real Stimulation
Ear stimulation at specific points should work by stimulating a nerve called the vagus nerve. Previous research has shown that stimulating this nerve can help patients feel less pain.
Behavioral: Real stimulation VS Sham
Ear stimulation at specific points should work by stimulating a nerve called the vagus nerve. Previous research has shown that stimulating this nerve can help patients feel less pain. During any testing session, participants may receive either the real ear stimulation or a sham (placebo) treatment. The sham treatment will use the same equipment as the real treatment, but will not deliver any real stimulation to the ear. We use placebo/sham procedures in research to make sure that the study results are related to the study procedure, and not to other reasons.
Sham Comparator: Sham
The sham treatment will use the same equipment as the real treatment, but the participant will not receive any real stimulation to the ear.
Behavioral: Real stimulation VS Sham
Ear stimulation at specific points should work by stimulating a nerve called the vagus nerve. Previous research has shown that stimulating this nerve can help patients feel less pain. During any testing session, participants may receive either the real ear stimulation or a sham (placebo) treatment. The sham treatment will use the same equipment as the real treatment, but will not deliver any real stimulation to the ear. We use placebo/sham procedures in research to make sure that the study results are related to the study procedure, and not to other reasons.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Characterize analgesia following verum and sham RAVANS treatment in Endometriosis patients with and without psychiatric co-morbidity.
Time Frame: 2-3 weeks
This will be done by comparing the quantitative sensory testing between the real and sham vagus nerve stimulation sessions.
2-3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vitaly Napadow, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2008p001019

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.

Clinical Trials on Endometriosis

Clinical Trials on Real stimulation VS Sham

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings