Chronic Pain Clinical Trial
— TRiPPOfficial title:
Translational Research in Pelvic Pain. Deep Phenotyping of Women With Endometriosis-associated Pain and Bladder Pain Syndrome
Verified date | November 2022 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to better understand the pathways leading to pain in women with two types of pelvic pain condition (endometriosis-associated pain and bladder pain syndrome) and determine whether these pathways can be used to subgroup patients.
Status | Completed |
Enrollment | 787 |
Est. completion date | February 23, 2023 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Female, aged 18 - 50 years. - Participant is willing and able to give informed consent for participation in the study. - EAP/EABP/CON: previously enrolled in EndOX or BCE cohorts with consent to be contacted again. - EAP: Surgical diagnosis of endometriosis; at least one pelvic pain >3/10. - EABP: Surgical diagnosis of endometriosis; at least one pelvic pain >3/10; pain perceived by the patient as arising from the bladder AND from other area(s) of the pelvis; at least one urinary symptom (e.g. urge, frequency). - BPS: fulfil ESSIC criteria (Pelvic pain, pressure or discomfort for greater than 6 months, perceived to be related to the urinary bladder accompanied by at least one other urinary symptom like persistent urge to void or frequency). Exclusion Criteria: - Female participant who is pregnant, lactating or planning pregnancy during the course of the study. - Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. - EAP: pain perceived by the patient as arising from the bladder; urinary symptoms (e.g. urge, frequency). - CON: previous diagnosis of endometriosis; pelvic pain or dysmenorrhoea (NRS>3/10) - BPS: previous diagnosis of endometriosis. Additionally, for physiological testing: Exclusion: • Participants who have participated in another research trial involving an investigational product in the past 12 weeks. And for fMRI: Inclusion: • fMRI compatible. Exclusion: - Contraindication to fMRI scan i.e. metallic implants, stents, clips, weight greater than acceptable for local fMRI scanner etc. - Use of centrally acting drugs in the previous 3 months (e.g. anti-epileptics, anti-depressants, anxiolytics, gabapentin, pregabalin, duloxetine). N.B. Regular use of standard analgesics including opiates is not an exclusion criterion, however, women will be asked to refrain from taking such drugs for 8 hours prior to their brain scan if at all possible. |
Country | Name | City | State |
---|---|---|---|
Portugal | IBMC | Porto | |
United Kingdom | University of Oxford | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Aalborg University, Bayer, Boston Children's Hospital, Endometriosis.org, Esteve, Grünenthal GmbH, Heidelberg University, International Painful Bladder Foundation, King's College London, Michigan State University, Pelvic Pain Support Network, Queen Mary University of London, Universidade do Porto, University of Edinburgh, University of Jena, Westfälische Wilhelms-Universität Münster |
Portugal, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative Sensory Testing (QST) | QST of the dorsal of the foot and midline lower abdomen according to the German Neuropathic Pain Network Protocol. | 1 year | |
Primary | Presence of abdominal wall muscle tenderness | Assessment of the abdominal wall specifically looking for muscle tenderness according to a standardised protocol (an enhanced Carnetts test as described by Scheltinga and Roumen 2017). Subjects will be categorised into muscle tenderness present or absent. | 1 year | |
Primary | Change of pressure pain threshold (PPT) | A standardised conditioned pain modulation (CPM) paradigm will be used to investigate the change in pressure pain threshold on the dorsum of the foot. An ischaemic stimulus to the contralateral arm will be used as the conditioned stimulus. The foot PPT will be measured before the conditioned stimulus and immediately after. The change will be reported as the (PPTbefore - PPTafter). | 1 year | |
Primary | Area under the curve (AUC) of single day salivary cortisol profile | Saliva will be collected at home at the specified times allowing a daily AUC of salivary cortisol for each subject to be calculated. Collection times: waking; 30-45 minutes after waking; before lunch; before dinner; bedtime. | 1 year | |
Primary | Change in salivary cortisol | A saliva sample will be collected at rest immediately before the CPM paradigm described in outcome 3 and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as Cortisol(before)-Cortisol(after). | Saliva collected immediately before and immediately after CPM paradigm (outcome 3). | |
Primary | Heart rate (HR) | Assessed over a 20 minute period at rest. | 1 year | |
Primary | Change in heart rate | Assessed at rest immediately before the CPM paradigm described in outcome 3 and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as HR(before) - HR(after). | HR assessed immediately before and immediately after the CPM paradigm (outcome 3) | |
Primary | Blood pressure (BP) | Assessed over a 20 minute period at rest. Measured in mmHG. | 1 year | |
Primary | Change in Blood pressure | Assessed at rest immediately before the CPM paradigm described in outcome 3 and then again immediately after. The ischaemic pain stimulus used as the conditioning stimulus in this paradigm is the most noxious component of the physiological testing paradigms used in this study and therefore the most likely to generate a stress response. The change will be reported as BP(before) - BP(after). | BP assessed immediately before and immediately after the CPM paradigm (outcome 3) | |
Primary | Bladder sensitivity to filling | Assessed with standardised non-invasive bladder filling paradigm, measured as time to verbal reports of different sensations of bladder fullness (first sensation, first urge) and then need to void (maximum tolerance) after drinking 600 ml water. Subjects will be categorised into those with bladder sensitivity compared to published norms for reproductive age women and those with normal bladder sensation. | 1 year | |
Primary | Volume voided at maximum tolerance | Assessed with standardised non-invasive bladder filling paradigm described in outcome 10. The volume of urine voided when maximum tolerance is reached will be measured in mls. | 1 year | |
Primary | fMRI scan | fMRI scan with response to punctate stimuli of midline lower abdomen. | 1 year | |
Primary | Pain Catastrophising: Pain Catastrophising Scale (PCS) (Sullivan) | Measured with the Pain Catastrophising Scale (Sullivan). Scores range from 0 - 52 with high scores representing higher levels of pain catastrophising. Although three sub scales exist they will not be assessed for the purposes of these main analyses. | Baseline | |
Primary | Comorbid psychological distress | Measured with the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 - 21 for each of the two sub scales measuring anxiety and depression. The two sub scales will be summed as a unidimensional measure of psychological distress in initial analyses (0 - 42 with higher scores representing greater distress). | Baseline | |
Secondary | Metabolomic data | Discovery study of levels of all known metabolite in plasma using an established validated proprietary tool designed by Metabolon (https://www.metabolon.com). | Baseline | |
Secondary | Proteomic data | Study measuring levels of proteins detected on two panels (inflammation and neurological) as designed by OLink (https://www.olink.com). | Baseline | |
Secondary | Transcriptomic data | Discovery transcriptomic analysis of matched eutopic and ectopic endometrium from endometriosis and control women will be performed on a subgroup of participants. Both descriptive data and pathway analysis will be performed. | Baseline | |
Secondary | Comorbidities | Assessed with the complex medical symptoms inventory (CMSI).
The CMSI contains a 41 item symptom screener, which an increasing score on adds up to a higher functional somatic burden (scores range from 0-41). Additionally, clusters of symptoms point to specific diagnoses for which the full diagnostic criteria questions are provided allowing the commonest overlapping pain conditions to be screened for: Fibromyalgia temporomandibular disorders irritable bowel syndrome chronic tension type headache migraine chronic low back pain myalgic encephalitis/chronic fatigue syndrome interstitial cystitis/painful bladder syndrome endometriosis vulvodynia |
Baseline | |
Secondary | Past trauma | Assessed with the Childhood Traumatic Events Scale (CTES). Scores range from 0 - 42 with higher scores representing more experience of early trauma. No sub scales will be derived. | Baseline | |
Secondary | Recent trauma | Assessed with the Recent Traumatic Events Scale (RTES). Scores range from 0 - 42 with higher scores representing more experience of recent trauma. No sub scales will be derived. | Baseline |
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