Back to resultsEar Electro-stimulation for Chronic Pelvic Pain (RAVANS)
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real stimulation VS Sham
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real Stimulation
Sham
Arm Description
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.
The sham treatment will use the same equipment as the real treatment, but the participant will not receive any real stimulation to the ear.
Outcomes
Primary Outcome Measures
Characterize analgesia following verum and sham RAVANS treatment in Endometriosis patients with and without psychiatric co-morbidity.
This will be done by comparing the quantitative sensory testing between the real and sham vagus nerve stimulation sessions.
Secondary Outcome Measures
Full Information
NCT ID
NCT01345331
First Posted
April 27, 2011
Last Updated
April 28, 2011
Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01345331
Brief Title
Ear Electro-stimulation for Chronic Pelvic Pain
Acronym
RAVANS
Official Title
Ear Electro-stimulation for Chronic Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
The sham treatment will use the same equipment as the real treatment, but the participant will not receive any real stimulation to the ear.
Intervention Type
Behavioral
Intervention Name(s)
Real stimulation VS Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Characterize analgesia following verum and sham RAVANS treatment in Endometriosis patients with and without psychiatric co-morbidity.
Description
This will be done by comparing the quantitative sensory testing between the real and sham vagus nerve stimulation sessions.
Time Frame
2-3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitaly Napadow, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ear Electro-stimulation for Chronic Pelvic Pain
We'll reach out to this number within 24 hrs