Ear Electro-stimulation for Chronic Pelvic Pain (RAVANS)

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01345331
First received: April 27, 2011
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Endometriosis
Behavioral: Real stimulation VS Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ear Electro-stimulation for Chronic Pelvic Pain

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Characterize analgesia following verum and sham RAVANS treatment in Endometriosis patients with and without psychiatric co-morbidity. [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
    This will be done by comparing the quantitative sensory testing between the real and sham vagus nerve stimulation sessions.


Enrollment: 18
Study Start Date: May 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345331

Locations
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Vitaly Napadow, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Dr. Vitaly Napadow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01345331     History of Changes
Other Study ID Numbers: 2008p001019
Study First Received: April 27, 2011
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014