Pelvic PainNCT06101303
Endometriosis Pain
An observational study of Pelvic Pain and Endometriosis, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women only
- Conditions the study is for
- Pelvic Pain, Endometriosis
- What is being tested?
- Psychophysical assessment, Psychophysical assessments of experimental pain and Blood, urine and saliva samples
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to 1 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Female patients with pelvic pain scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
Who may be able to join
- Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
- Age 12-45
- Females
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hadas Nahman-Averbuch contact
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Hadas Nahman-Averbuch, PhD, 314-273-6194, painlab@wustl.edu
Alana McMichael, MA, 314-273-6194, painlab@wustl.edu
About this study
Official title: The Mechanisms Underlying Endometriosis Pain
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.
Read more
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).
Read the detailed description
Pre-Study Period
Participants will be recruited via the pain and Ob/Gyn clinics and via EPIC. Potential participants might be identified via EPIC records using age, sex, diagnoses, notes, problem list, medications, date of scheduled surgery, name of physician performing the surgery, and phone number.
A research staff member will contact a potential participant and provide a description of the project. Potentially eligible participants will be invited to participate in the study, which will be conducted at Washington University School of Medicine. Participants will also be provided with a written summary or the consent of the study. The consent will be signed electronically, using Docusign e-consent process or remotely during a phone call or a video call (WUSTL Zoom) with a study staff or in person.
Study Design
After confirming the inclusion criteria and signing the consent form, patients with pelvic pain potentially due to endometriosis will complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. Patients will also complete various questionnaires including demographic, social, health, behavioral, and psychological questionnaires. . 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). Obstetric, gynecologic, fertility, and surgical history will be abstracted from the medical record and/or via health history interview. These procedures will be completed before the surgery.
During the surgery, the endometriosis lesions will be excised as part of routine care. At least one lesion will be sent to pathology and one lesion for the study team. In the absence of lesions, peritoneally biopsies of bilateral infra-ovarian fossa will be collected per routine practice. One will be sent to pathology, and one for the study team. Vials of health abdominal peritoneum, and endometrial biopsy (if uterus present) will be collected for study purpose.
Before or on the day of the surgery, blood, urine, and/or saliva samples will be collected for hormonal, immune and genetic testing. Additional samples will be stored in a biobank for future hormonal, immune and/or genetic analyses.
In addition, after the surgery, participants will be asked to complete surveys assessing pain and other symptoms which will be sent every week for the first month and then monthly for 1 year.
After the surgery, participants will have the option to return for additional study visits that will include the same psychophysical procedures and collection of blood (about 20 ml), urine, and/or saliva samples (3 months, 6 months and 1 year after surgery).
During the study period, new about pelvic pain, new/changes in diagnosis, treatment changes (medication titration, physical therapy, mental health, and alternative therapies), surgery related data, additional pain-related diagnoses, and additional markers (i.e., vitamin D, hormone levels) will also be collected via EPIC and/or health history interview.
All study procedures are optional and participants can stop or not complete tests if they want.
Participants need to meet all the inclusion criteria to be included in the study. After consenting and the first study visit, changes in health will not automatically lead to excluding participants from the study. Before the follow-up visits, the investigators will ask the participants about changes in their health (from the last visit). Based on the responses, continuation/withdrawal from the study and/or omission of study activities will be determined at the discretion of the PI and/or study staff.
- Conditions
- Pelvic Pain, Endometriosis
- Being tested
- Psychophysical assessment, Psychophysical assessments of experimental pain, Blood, urine and saliva samples, Biopsy and surgery-related data.
- Medical subject headings
- Pelvic Pain, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychophysical assessmentOther
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 painBehavioural
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 samplesDiagnostic test
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.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic pain | Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment Receives: Other: Psychophysical assessment; Behavioral: Psychophysical assessments of experimental pain; Diagnostic Test: Blood, urine and saliva samples; Procedure: Biopsy and surgery-related data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain ratings of clinical pain
Rating the pain intensity level using a numerical pain scale (0-100) or visual analog scale
Measured: Baseline and follow up (3 months, 6 months and 1 year after surgery)
Estrogen levels
systemic estrogen level and local estrogen level from the lesion
Measured: Baseline
Estrogen receptor expression in the lesion
analyzing the levels of estrogen receptor expression in the endometriosis lesion
Measured: Baseline
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.
Measured: 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.
Measured: Baseline and follow up (3 months, 6 months and 1 year after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start29 Sep 2023
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadas Nahman-Averbuch, Washington University School of Medicine
- Investigators
- Hadas Nahman-Averbuch, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101303
- Sponsor's protocol ID
- 202305023
- Status last verified
- Jul 2026
- First submitted
- 2 Oct 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanisms Underlying Endometriosis Pain
- ClinicalTrials.gov ID
- NCT06101303
- Acronym / sponsor ID
- 202305023
- Conditions
- Pelvic Pain, Endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Pre-Study Period
Participants will be recruited via the pain and Ob/Gyn clinics and via EPIC. Potential participants might be identified via EPIC records using age, sex, diagnoses, notes, problem list, medications, date of scheduled surgery, name of physician performing the surgery, and phone number.
A research staff member will contact a potential participant and provide a description of the project. Potentially eligible participants will be invited to participate in the study, which will be conducted at Washington University School of Medicine. Participants will also be provided with a written summary or the consent of the study. The consent will be signed electronically, using Docusign e-consent process or remotely during a phone call or a video call (WUSTL Zoom) with a study staff or in person.
Study Design
After confirming the inclusion criteria and signing the consent form, patients with pelvic pain potentially due to endometriosis will complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. Patients will also complete various questionnaires including demographic, social, health, behavioral, and psychological questionnaires. . 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). Obstetric, gynecologic, fertility, and surgical history will be abstracted from the medical record and/or via health history interview. These procedures will be completed before the surgery.
During the surgery, the endometriosis lesions will be excised as part of routine care. At least one lesion will be sent to pathology and one lesion for the study team. In the absence of lesions, peritoneally biopsies of bilateral infra-ovarian fossa will be collected per routine practice. One will be sent to pathology, and one for the study team. Vials of health abdominal peritoneum, and endometrial biopsy (if uterus present) will be collected for study purpose.
Before or on the day of the surgery, blood, urine, and/or saliva samples will be collected for hormonal, immune and genetic testing. Additional samples will be stored in a biobank for future hormonal, immune and/or genetic analyses.
In addition, after the surgery, participants will be asked to complete surveys assessing pain and other symptoms which will be sent every week for the first month and then monthly for 1 year.
After the surgery, participants will have the option to return for additional study visits that will include the same psychophysical procedures and collection of blood (about 20 ml), urine, and/or saliva samples (3 months, 6 months and 1 year after surgery).
During the study period, new about pelvic pain, new/changes in diagnosis, treatment changes (medication titration, physical therapy, mental health, and alternative therapies), surgery related data, additional pain-related diagnoses, and additional markers (i.e., vitamin D, hormone levels) will also be collected via EPIC and/or health history interview.
All study procedures are optional and participants can stop or not complete tests if they want.
Participants need to meet all the inclusion criteria to be included in the study. After consenting and the first study visit, changes in health will not automatically lead to excluding participants from the study. Before the follow-up visits, the investigators will ask the participants about changes in their health (from the last visit). Based on the responses, continuation/withdrawal from the study and/or omission of study activities will be determined at the discretion of the PI and/or study staff.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic pain | – | Other: Psychophysical assessment, Behavioral: Psychophysical assessments of experimental pain, Diagnostic Test: Blood, urine and saliva samples, Procedure: Biopsy and surgery-related data.Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female patients with pelvic pain scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
Key inclusion criteria (3 listed)
- Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
- Age 12-45
- Females
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychophysical assessmentThermal 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. | Other | Pelvic pain |
| Psychophysical assessments of experimental painPain 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. | Behavioural | Pelvic pain |
| Blood, urine and saliva samplesBlood (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. | Diagnostic test | Pelvic pain |
| 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. | Procedure or surgery | Pelvic pain |
Primary outcome
Pain ratings of clinical pain
Time frame: Baseline and follow up (3 months, 6 months and 1 year after surgery)
Rating the pain intensity level using a numerical pain scale (0-100) or visual analog scale
Estrogen levels
Time frame: Baseline
systemic estrogen level and local estrogen level from the lesion
Estrogen receptor expression in the lesion
Time frame: Baseline
analyzing the levels of estrogen receptor expression in the endometriosis lesion
Conditioned pain modulation (CPM) response
Time frame: Baseline and follow up (3 months, 6 months and 1 year after surgery)
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.
1 secondary outcome
Pressure pain thresholds (PPT)
Time frame: Baseline and follow up (3 months, 6 months and 1 year after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Pelvic Pain
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadas Nahman-Averbuch contact
Hadas Nahman-Averbuch, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain and Endometriosis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alana McMichael, MA (314-273-6194, painlab@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain ratings of clinical pain (time frame: Baseline and follow up (3 months, 6 months and 1 year after surgery)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.