Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073801
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2003-12-08
Brief Title:
Pelvic Pain in Women With Endometriosis
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Neural Immune Mechanisms and Genetic Influences on Chronic Pelvic Pain in Women With Endometriosis
Status:
COMPLETED
Status Verified Date:
2024-04-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine pelvic pain associated with endometriosis and explore better approaches to treatment In women with endometriosis uterine tissue grows outside the uterus Standard treatments - altering hormone levels to prevent endometrial tissue growth or surgically removing endometrial tissue - treat pelvic pain only temporarily This study will investigate the role of sex hormones immune chemicals stress hormones and genes in pelvic pain and determine how the nerve muscle and skeletal systems are involved in this pain
Women between 18 and 50 years of age who
1 have endometriosis and chronic pelvic pain and
2 have chronic pelvic pain without endometriosis and
3 have neither endometriosis nor chronic pelvic pain and are willing to have a tubal ligation Healthy Volunteer group
may be eligible for this study Candidates are screened with a questionnaire to obtain information about their pain and previous treatments and related medical or social issues Participants will undergo the following tests and procedures
1 Medical history and physical examination including pelvic exam blood tests urinalysis and diaphragm fitting
2 Questionnaires about pain quality of life sexuality psychological attitudes spiritual experiences and history of headache and depression
3 At-home monitoring for 4 to 6 weeks of pain symptoms menstruation and spotting medicines taken and urine collections to test for LH surge LH is the hormone that causes the ovary to release a mature egg
4 Pre-laparoscopy evaluation to include
Examination of menstrual blood collected in a diaphragm for 4 hours
Blood sampling to measure adrenal and pituitary hormones For this test corticotrophin-releasing hormone CRH is injected through an IV needle Up to five blood samples are drawn starting before the injection until 45 minutes after it Blood is also collected at this time for genetic analysis
In-depth pain assessment to identify trigger points in muscles associated with pelvic pain regions of skin sensitivity and bone pain Some women will undergo microdialysis which uses an acupuncture-type needle to collect chemicals from two different muscles
Blood sampling twice a week for 1 month to measure changes in blood substances during the menstrual cycle
Blood sampling after the LH surge to measure progesterone levels
Cervicovaginal lavage washing of the cervix with saline and collecting the fluid to obtain secretions for research
Ultrasound of the ovaries and uterus This examination uses a probe inserted into the vagina that emits sound waves that are used to form pictures of the internal structures A small piece of uterine lining is also obtained for examination and research purposes
A visit with the members of the Pain and Palliative care service to evaluate the pain in anticipation of offering other treatments for pain after surgery
Surgery
CPP Endo or CPP only Laparoscopy to look for and remove endometrial tissue This procedure is done under general anesthetic A viewing instrument called a laparoscope is passed through an incision in the belly button to look for endometriosis If it is found two or more incisions are made in the abdomen for other instruments to remove the tissue A small piece of uterine lining is also obtained for examination and research purposes
Healthy Volunteers Laparoscopy to perform the tubal ligation A tubal ligation commonly known as getting your tubes tied is a surgical procedure for women to sterilize them This procedure closes the fallopian tubes stopping the egg from traveling from the ovary to the uterus and preventing sperm from reaching the fallopian tube to fertilize an egg In a tubal ligation fallopian tubes are cut burned or blocked with rings bands or clips The surgery is effective immediately Tubal ligations are 995 effective as birth control This procedure is done under general anesthetic A viewing instrument called a laparoscope is passed through an incision in the belly button to perform a tubal ligation Two or more incisions are made in the abdomen for other instruments to perform the procedure During the laparoscopy we will look for and remove endometrial tissue A small piece of uterine lining is also obtained for examination and research purposes
-Follow-up evaluations Two weeks after surgery patients return to NIH to discuss the surgical findings and treatment options Follow-up visits are then scheduled at 1 3 and 6 months after surgery to complete questionnaires and determine if the treatment is working Blood samples are drawn at each visit
Women between 18 and 50 years of age who
1 have endometriosis and chronic pelvic pain and
2 have chronic pelvic pain without endometriosis and
3 have neither endometriosis nor chronic pelvic pain and are willing to have a tubal ligation Healthy Volunteer group
may be eligible for this study Candidates are screened with a questionnaire to obtain information about their pain and previous treatments and related medical or social issues Participants will undergo the following tests and procedures
1 Medical history and physical examination including pelvic exam blood tests urinalysis and diaphragm fitting
2 Questionnaires about pain quality of life sexuality psychological attitudes spiritual experiences and history of headache and depression
3 At-home monitoring for 4 to 6 weeks of pain symptoms menstruation and spotting medicines taken and urine collections to test for LH surge LH is the hormone that causes the ovary to release a mature egg
4 Pre-laparoscopy evaluation to include
Examination of menstrual blood collected in a diaphragm for 4 hours
Blood sampling to measure adrenal and pituitary hormones For this test corticotrophin-releasing hormone CRH is injected through an IV needle Up to five blood samples are drawn starting before the injection until 45 minutes after it Blood is also collected at this time for genetic analysis
In-depth pain assessment to identify trigger points in muscles associated with pelvic pain regions of skin sensitivity and bone pain Some women will undergo microdialysis which uses an acupuncture-type needle to collect chemicals from two different muscles
Blood sampling twice a week for 1 month to measure changes in blood substances during the menstrual cycle
Blood sampling after the LH surge to measure progesterone levels
Cervicovaginal lavage washing of the cervix with saline and collecting the fluid to obtain secretions for research
Ultrasound of the ovaries and uterus This examination uses a probe inserted into the vagina that emits sound waves that are used to form pictures of the internal structures A small piece of uterine lining is also obtained for examination and research purposes
A visit with the members of the Pain and Palliative care service to evaluate the pain in anticipation of offering other treatments for pain after surgery
Surgery
CPP Endo or CPP only Laparoscopy to look for and remove endometrial tissue This procedure is done under general anesthetic A viewing instrument called a laparoscope is passed through an incision in the belly button to look for endometriosis If it is found two or more incisions are made in the abdomen for other instruments to remove the tissue A small piece of uterine lining is also obtained for examination and research purposes
Healthy Volunteers Laparoscopy to perform the tubal ligation A tubal ligation commonly known as getting your tubes tied is a surgical procedure for women to sterilize them This procedure closes the fallopian tubes stopping the egg from traveling from the ovary to the uterus and preventing sperm from reaching the fallopian tube to fertilize an egg In a tubal ligation fallopian tubes are cut burned or blocked with rings bands or clips The surgery is effective immediately Tubal ligations are 995 effective as birth control This procedure is done under general anesthetic A viewing instrument called a laparoscope is passed through an incision in the belly button to perform a tubal ligation Two or more incisions are made in the abdomen for other instruments to perform the procedure During the laparoscopy we will look for and remove endometrial tissue A small piece of uterine lining is also obtained for examination and research purposes
-Follow-up evaluations Two weeks after surgery patients return to NIH to discuss the surgical findings and treatment options Follow-up visits are then scheduled at 1 3 and 6 months after surgery to complete questionnaires and determine if the treatment is working Blood samples are drawn at each visit
Detailed Description:
Chronic pelvic pain associated with endometriosis is poorly understood This study is an effort to better understand pelvic pain and identify novel medical approaches for treating it Endometriosis is a very common disease of women in their reproductive years in which endometrial tissue grows outside the uterus In a recent epidemiologic study we have shown strong associations among endometriosis fibromyalgia and autoimmune disorders Currently it is believed that endometriosis causes chronic pelvic pain Yet some women with endometriosis do not have any pain and others have pain in areas unrelated to endometriosis disease location The standard approaches to treating endometriosis pain have been to medically alter hormone levels to prevent endometriosis tissue growth or to surgically remove endometriosis lesions Pelvic pain is only temporarily treated by either approach which suggests that the current classification of pain based on disease and treatment with hormones or surgery is not adequate The feeling of pain involves many complex processes Generally women suffer more frequently from chronic long-term painful conditions than men This suggests that women process pain differently because of differences in sex hormone levels and genes expressed in a sexually dimorphic fashion as well as in central nervous and immune system function differences We will examine the relations among sex hormones pain processing immune system substances and pain related genes We will also examine changes in levels of hormonal and immune substances in the blood endometriosis lesions and normal endometrial tissue Myofascial pain has been noted in women with endometriosis and chronic pelvic pain We will study how the nerve muscle and skeletal systems are involved in pelvic pain by performing an in depth pain assessment Finally stress plays an important role generating and perpetuating chronic pain We will examine how the hormones related to the stress response may be altered in pelvic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0056 | None | None | None |