Testing pain sensitivity in women with endometriosis
Quantitative Sensory Testing and Central Sensitization in Endometriosis
This study is testing six different questionnaires to see how well they measure pain sensitivity in women with endometriosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 19 Years to 49 Years |
| Sex | Female |
| Sponsor | BC Women's Hospital & Health Centre Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06215937 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate six patient-reported questionnaires as measures of central sensitization (CS) in women diagnosed with endometriosis. The questionnaires being evaluated include the Central Sensitization Inventory, Pain Sensitivity Questionnaire, Douleur Neuropathique 4, painDETECT, Self Administered Leeds Assessment of Neuropathic Symptoms and Signs, and Fibromyalgia Survey Score. The study will compare these questionnaires to each other and assess their correlation with quantitative sensory testing (QST) thresholds, which objectively measures pain sensitivity. By establishing the effectiveness of these questionnaires, the study seeks to enhance the understanding of pain mechanisms in endometriosis.
Who should consider this trial
Good fit: Ideal candidates are women aged 19 to 49 with surgically confirmed or clinically suspected endometriosis who are willing to complete the questionnaires and undergo QST testing.
Not a fit: Patients who are currently pregnant, breastfeeding, post-menopausal, or do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated method for assessing pain sensitivity in endometriosis patients, leading to better pain management strategies.
How similar studies have performed: While there is limited direct comparison among these questionnaires in endometriosis, the approach of validating subjective measures against objective testing has shown promise in other pain-related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * New or re-referral appointment at the BC Women's Centre for Pelvic Pain and Endometriosis. * Consented to be contacted for future research in the centre data registry (EPPIC NCT02911090; H16-00264). * Surgically confirmed endometriosis, current imaging diagnosis, or current clinically suspected endometriosis diagnosed at the new or re-referral appointment as coded in the registry. * 19 to 49 years old. * Willing and committed to completing six questionnaires about pain. QST specific criteria • Willing and committed to QST testing. Exclusion Criteria: * Currently pregnant or breastfeeding. * Post-menopausal. * Does not speak English - Patients who do not speak English will be excluded to maintain the safety and well-being of the patient, as not understanding the test and process may harm the patient and reduce the validity of the results. We do not have research funding for a translator. Additionally, patients who require a translator are not typically included in the data registry and therefore are unlikely to be in our sample. QST specific criteria * Diabetes or neurological disease predisposing to neuropathic pain. * Previous laparotomy (i.e. large abdominal incision) * Physical trauma (ex., surgery, scaring) to heterotropic QST test site(s) (i.e. deltoid muscle in the shoulder, thenar eminence).
Where this trial is running
Vancouver, British Columbia
- BC Women's Hospital + Health Centre — Vancouver, British Columbia, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.