Quantitative Sensory Testing and Central Sensitization in Endometriosis

NCT06215937 | Recruiting

• 1 other identifier: H22-02631
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a gynecologic condition where there is growth of endometrial-like tissue outside the uterus, leading to severe pelvic pain. Despite conventional treatment, many patients experience persistent pelvic pain due to central sensitization (CS), where the central nervous system amplifies pain signals. Quantitative Sensory Testing (QST) enables objective testing of CS. However, there are several patient-reported questionnaires that have shown promising potential as subjective proxies of CS. Therefore, in this study, our objective is to validate six patient-reported questionnaires as measures of CS by comparing them to each other and determining whether each questionnaire correlates with QST thresholds.

Conditions

Endometriosis; Pain

Outcome Measures

Primary Outcomes (1)

• Central Sensitization

  Quantitative Sensory Testing thresholds for assessment of Central Sensitization

  Feb 1st 2023 - Jan 31st 2026

Interventions

No Intervention OTHER

No intervention

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have a new or re-referral appointment at the BC Women's Centre for Pelvic Pain and Endometriosis and who consented to the EPPIC registry (H16-00264).

You may qualify if:

• 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.
• to 49 years old.
• Willing and committed to completing six questionnaires about pain.
• QST specific criteria
• Willing and committed to QST testing.

You may not qualify if:

• 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).

Sponsors & Collaborators

• BC Women's Hospital & Health Centre: lead
• University of British Columbia: collaborator

Study Sites (1)

BC Women's Hospital + Health Centre

Vancouver, British Columbia, V6H 2N9, Canada

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: May 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)