Ear Electro-stimulation for Chronic Pelvic Pain (RAVANS)

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: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Behavioral: Real stimulation VS Sham

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: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	2-3 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Vitaly Napadow, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID Numbers: 2008p001019