Endometriosis Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age12-45
SponsorWashington University School of Medicine
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
Age 12-45
Females
Disqualifiers
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
Trial population
Female patients with pelvic pain scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Psychophysical assessment
Other interventionThermal 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
BehavioralPain 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
Diagnostic testBlood (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.
Procedure/SurgeryDuring 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Pelvic pain4 interventions
Trial outcomes
Primary outcomes
1
Pain ratings of clinical pain
Rating the pain intensity level using a numerical pain scale (0-100) or visual analog scale
Time frame
Baseline and follow up (3 months, 6 months and 1 year after surgery)2
Estrogen levels
systemic estrogen level and local estrogen level from the lesion
Time frame
Baseline3
Estrogen receptor expression in the lesion
analyzing the levels of estrogen receptor expression in the endometriosis lesion
Time frame
Baseline4
Conditioned pain modulation (CPM) response
The CPM paradigm assesses endogenous inhibitory pain modulation efficiency. CPM testing includes the application of a "test" stimulus without conditioning (control run, pressure pain thresholds) and a subsequent application of the same test stimulus together with a conditioning stimulus (conditioning run, a 60 second of foot immersion in cold water). The CPM response is the difference in the pressure pain thresholds between the control and the conditioning runs.
Time frame
Baseline and follow up (3 months, 6 months and 1 year after surgery)Secondary outcomes
1
Pressure pain thresholds (PPT)
Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements.
Time frame
Baseline and follow up (3 months, 6 months and 1 year after surgery)Sponsors and contacts
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Source ClinicalTrials.gov