Recruiting

Endometriosis

Sponsor:

Washington University School of Medicine

Code:

NCT06101303

Conditions

Pelvic Pain

Endometriosis

Eligibility Criteria

Sex: Female

Age: 12 - 45

Healthy Volunteers: Not accepted

Interventions

Psychophysical assessment

Psychophysical assessments of experimental pain

Blood, urine and saliva samples

Biopsy and surgery-related data.

Study Details

Brief summary:

Aim 1. To determine the factors contributing to pain in patients with chronic pelvic pain with and without endometriosis Aim 2. To determine the changes following endometriosis lesion removal surgery in pain and sex hormone levels.

Aim 3. To identify factors predicting clinical pain reduction after lesion removal surgery.

Additional exploratory aims might compare subgroups of patients such as patients with vs. without endometriosis, with vs. without additional chronic pain syndromes, and with vs. without hormonal treatment. In addition, the role of lesion-specific immune signatures and psychological factors on pain will be explored.

Patients with pelvic pain potentially due to endometriosis will complete questionnaires including social, health, behavioral, and psychological questionnaires. Patients will also complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. In addition, blood, urine, and saliva samples will be collected for hormonal, immune, and genetic analyses. Additional samples might be collected and stored for future analyses. For some participants, these procedures will be completed several times, including before the surgery as well as 3 months, 6 months and 1 year after surgery. After the surgery, surveys assessing pain and other symptoms will be sent every week on the first month and then monthly for 1 year. In addition, during the surgery, biopsies will be collected and analyzed to determine hormonal, immune and genetic factors.

For adolescents, a parent/legal guardian will be asked to assist in completing some of the health-related surveys (i.e., physical developmental survey, health survey, migraine history survey).

Conditions

Pelvic Pain

Endometriosis

Study ID

NCT06101303

Start date

Sep 29, 2023

Status verified date

Jul, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 45

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
  • Age 12-45
  • Females

Exclusion criteria:

  • Pregnancy
  • Planned hysterectomy or oophorectomy
  • Co-occurring vaginismus and/or vulvodynia
  • For patients aged 12-17 not having a parent/legal guardian willing to sign the consent and answer surveys about their child's health

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Pelvic pain

Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment

Interventions

Psychophysical assessment

Thermal stimuli: The Thermal Sensory Analyzer will be used to deliver heat and cold stimuli. All targeted stimulus temperatures will be less than 50°C, and participants will be free to remove their arm or leg at any time from the thermode. Noxious cold stimuli will also be delivered with a plastic water bath or an electronic electronic temperature-controlled water bath. Participants will be free to pull out of the water bath at any time.

Pressure stimuli: Pressure stimuli will be applied by using a handheld algometer. These devices have a round probe that allows quantifying the amount of pressure that is being applied by real-time visual feedback to control and monitor applied pressure rates. Pressure will be applied to the lower leg, volar forearm, or trapezius.

Mechanical stimuli: A set of standardised von Frey filaments (0.25, 0.5, 1, 2, 4, 8, 16, 32, 64, 128 and 256mN). The contact area of the hairs with the skin is of uniform size (<1 mm²) and texture.

Psychophysical assessments of experimental pain

Pain ratings- Pain intensity and pain unpleasantness ratings will be assessed

Pain thresholds to heat, cold and/or pressure will be tested and participants will be instructed to press a button the first moment they feel pain.

Temporal summation- participants will rate the pain evoked by a single pinprick stimulus and by a series of 10 identical pinprick stimuli.

Conditioned pain modulation (CPM) efficiency - CPM testing includes the application of a "test" stimulus without conditioning (heat or pressure stimuli) and a subsequent application of the same test stimulus together with a conditioning stimulus (cold stimulus).

Offset analgesia will be assessed using the three-temperature method (T1°C 5s, T1+1°C 5s, T1°C 20s). During the OA paradigm, real time pain intensity ratings will be obtained

Cold pain tolerance will be assessed by having participants immerse their hand or foot in a cold water bath. Tolerance will be defined by the time of hand/foot withdrawal.

Blood, urine and saliva samples

Blood (approximately 2 tablespoons), urine and saliva samples will be collected and sent to ZRT Laboratory, LabCorp, or internal Washington University lab for analyses of sex hormone levels (e.g., testosterone, estradiol, progesterone). Additional samples will be stored in a biobank for future processing.

Biopsy and surgery-related data.

During the surgery, biopsies will be collected from the endometriosis lesions as well as from a healthy peritoneum. If there are no endometriosis lesions, biopsies will be taken of two common locations where endometriosis lesion grows (the infra-ovarian fossa). The lesions will be characterized based on their appearance and invasiveness of the lesions (i.e., powder-burn lesions, nonclassical red or white lesions, and superficially or deeply infiltrating (>5mm) lesions). In addition, surgery-related data such as the incision size, type of anesthesia, pain ratings after the surgery, analgesic medication after the surgery, and side effects will be documented. Blood, saliva, urine, and samples will be collected for hormonal analyses or stored in a Biobank for future analyses.

Primary outcome measure

  • Pain ratings of clinical pain [ Time Frame: Baseline and follow up (3 months, 6 months and 1 year after surgery) ]
  • Estrogen levels [ Time Frame: Baseline ]
  • Estrogen receptor expression in the lesion [ Time Frame: Baseline ]
  • Conditioned pain modulation (CPM) response [ Time Frame: Baseline and follow up (3 months, 6 months and 1 year after surgery) ]

Central Contacts and Locations

Central contacts

Alana McMichael, MA

314-273-6194painlab@wustl.edu

Hadas Nahman-Averbuch

314-273-6194

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Hadas Nahman-Averbuch, PhD

314-273-6194painlab@wustl.edu

Alana McMichael, MA

314-273-6194painlab@wustl.edu

Principal Investigator:

Hadas Nahman-Averbuch, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-13.