Active Diabetes, Hormones & Metabolism

PanacEa Trial: Clinical and Cost-Effectiveness of Pain Management Programme for Endometriosis versus Standard Care

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A remotely delivered 12-week pain management programme is being tested against standard care for women with endometriosis whose chronic pain persists after surgery or medication. Endometriosis affects 1 in 10 women, causing pelvic pain and fatigue, with no known cure. Pain recurs in 50% of cases within five years after surgery and hormonal treatment, leaving many women with limited options. This trial addresses the lack of evidence for whether a tailored pain management programme—combining cognitive behavioural therapy, physiotherapy, and education—can improve quality of life when standard treatments fail. If the programme proves clinically and cost-effective, it could change how the NHS manages refractory endometriosis pain. The findings may influence NICE and ESHRE guidelines, offering a non-surgical, non-hormonal option for women who prioritise fertility or cannot tolerate side effects. Cost-effectiveness data would also inform resource allocation and policy, potentially reducing healthcare use by helping women manage pain without repeated surgeries or emergency visits.

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Research Question: Is an endometriosis-specific pain management programme (e-PMP) clinically and cost-effective for endometriosis-related chronic pain not adequately controlled by surgery and/or pharmacological treatment? Background: Endometriosis affects 1 in 10 women, causing pelvic pain, fatigue, and reduced quality of life (QoL). There is no known cure. Treatment typically involves surgery or hormonal medications, which have side effects and limited long-term effectiveness, with pain recurring in 50% of cases within 5 years after surgery and hormonal treatment. Pain management programs (PMPs) may improve QoL in chronic pain conditions but require more evidence for endometriosis. Aims and Objectives Aim: To determine if e-PMP in addition to standard care is clinically and cost-effective for improving QoL in women with endometriosis-related chronic pain. Objectives: To compare e-PMP plus standard care with standard care alone at 12 months post-randomisation in terms of: 1) health-related QoL, functional health, and well-being; and 2) cost-effectiveness in terms of the incremental cost per QALY gained at 12 months and long-term modelling. Methods: A superiority RCT will compare e-PMP plus standard care with standard care alone in premenopausal women aged 16 years and above with persistent endometriosis-related chronic pelvic pain not controlled by surgical and/or pharmacological treatment. The e-PMP is a remotely delivered 12-week interdisciplinary program combining Cognitive Behavioural Therapy (CBT)-informed psychotherapy, physiotherapy, education on endometriosis, pain and fatigue management, aiming to reduce pain-related distress and improve QoL. The e-PMP alternates between group-based and 1:1 sessions; totalling 2.5 hours per week with a booster session at 24 weeks. Session content will introduce the role of psychology and physical activity in pain management, provide information to help people understand their condition/symptoms and persistent pain, explore activity and fatigue management, flare-ups, values, management of pelvic floor dysfunction, relationships, intimacy, communication, self-compassion, and optimise pain medications to reduce side effects. Timelines for delivery: Start date: 1 January 2026; Study duration: 60 months. Milestones: prefunding (regulatory approvals, site engagement); months 1-9 (set-up, authorisations, site training); months 10-39 (patient recruitment); months 40-51 (patient follow-up to 12 months); months 52-60 (follow-up, data analysis, reporting). Impact and dissemination Impact: Findings will influence endometriosis care guidelines (NICE, ESHRE), provide more treatment options for women with refractory endometriosis pain, including those prioritising fertility, and reduce healthcare use. Cost-effectiveness data will inform resource allocation and policy. Dissemination: Results will be shared with clinicians, academics, patients, and policymakers through publications, conferences, media outreach, and plain language summaries on social media, University and endometriosis charities' websites, and a video summarising findings for patients.

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Recurrence of Endometriosis: a randomised controlled trial of clinical and cost effectiveness of Gonadotrophin Releasing Hormone Analogues with add back hormone replacement therapy versus repeat Laparoscopic surgery (REGAL trial)
Deep infiltrating endometriosis: management by medical treatment versus early surgery: DIAMOND

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