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L'essai clinique NCT06778070 (POPPY) pour Chronic Pelvic Pain Syndrome (CPPS), Syndrome de la douleur pelvienne chronique, Douleur pelvienne chronique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université de Californie à San FranciscoNational Program to Overcome Pelvic Pain studY (POPPY)
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L'étude clinique NCT06778070 (POPPY) est un essai interventionnel pour Chronic Pelvic Pain Syndrome (CPPS), Syndrome de la douleur pelvienne chronique, Douleur pelvienne chronique. Son statut actuel est : en recrutement. L'étude a débuté le 12 mai 2025 et vise à recruter 220 participants. Dirigé par l'Université de Californie à San Francisco, l'essai devrait être terminé d'ici le 15 mars 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 23 mai 2025.
Résumé succinct
A randomized, parallel-group, investigator-blinded, comparative effectiveness trial of a fully remote, videoconference-based pelvic floor yoga program versus a physical conditioning program for women with chronic pelvic pain syndrome.
Titre officiel
National Program to Overcome Pelvic Pain studY (POPPY)
Conditions
Chronic Pelvic Pain Syndrome (CPPS)Syndrome de la douleur pelvienne chroniqueDouleur pelvienne chroniqueAutres identifiants de l'essai
- POPPY
- 24-41220
- R01AT012461 (Subvention/contrat NIH (É.-U.))
Numéro NCT
Date de début (réel)
2025-05-12
Dernière mise à jour publiée
2025-05-23
Date de fin (estimée)
2029-03-15
Inscription (estimée)
220
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalPelvic floor yoga program Instruction in the therapeutic yoga intervention will be delivered through 75-minute group classes occurring twice weekly for a 2-month (8-week) intervention instruction period, involving a trained instructor and an expected 6-10 students (a.k.a. participants) using a secure Zoom videoconference platform.
Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. | Pelvic Floor Yoga Pelvic floor yoga |
Comparateur actifPhysical conditioning program (Skeletal muscle stretching and strengthening program) The physical conditioning program (skeletal muscle stretching and strengthening program) intervention will begin with a group orientation led by a physical trainer, who will provide an overview of the program. This will be followed by 75-minute twice-weekly group classes, each with an expected class size of 6-10 participants, led by the same physical trainer who has received study-specific training from the study's expert physical therapist consultant, and using a secure Zoom videoconference platform.
Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. | Physical Conditioning Physical conditioning |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Pelvic pain intensity "on average" using standard 0-10 numerical rating scale, measured using logs in which participants self-report pain intensity over the past week, and assessed over 4 months of intervention | 4 months of intervention (2 months of instruction as well as 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
Pelvic pain intensity "at its worst" using standard 0-10 numerical rating scale, measured using logs in which participants to self-report pain intensity over the past week, and assessed over 4 months of intervention | 4 months of intervention (2 months of instruction as well as 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Percent of participants achieving reductions in pelvic pain intensity "on average" of at least 30% from baseline (using a standard 0-10 numerical rating scale) after 4 months of intervention | 4 months of intervention (2 months of instruction as well as 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
Percent of participants achieving reductions in pelvic pain intensity "at its worst" of at least 30% from baseline (using a standard 0-10 numerical rating scale) after 4 months of intervention | 4 months of intervention (2 months of instruction as well as 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
Psychological impact of chronic pelvic pain, measured by the psychological domain score of the Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) over 4 months of intervention | 4 months of intervention (2 months of instruction as well as 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
Sexual impact of chronic pelvic pain, measured by the sexual domain score of the Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ) over 4 months of intervention | 4 months of intervention (2 months of instruction as well as 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
General interference of pain with daily functioning in women with CPPS, as measured by scores on the PROMIS Pain Interference 4a measure from baseline to 4 months of intervention | 4 months of intervention (2 months of instruction as well as 2 months of maintenance. | After 4 months of intervention instruction and maintenance period. |
Perceived stress as measured by scores on the 4-item Perceived Stress Scale over the 4-month intervention period | 4-month intervention period (2 months of intervention instruction and 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
Sleep quality as measured by scores on the PROMIS Sleep Disturbance Short Form over the 4-month intervention period | 4-month intervention period (2 months of intervention instruction and 2 months of maintenance). | After 4 months of intervention instruction and maintenance period. |
Pelvic problems-related sexual function as measured by scores on the Pelvic Problems Interference subscale of the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) over the 4-month intervention period | 4-month intervention period (2 months of intervention instruction and 2 months of maintenance) | After 4 months of intervention instruction and maintenance period. |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
- Women (individuals reporting female sex assigned at birth who self-identify as women or non-binary) aged 18 years or older
- Report chronic or recurrent pain in the pelvis (between or below the anterior iliac crests) for at least 6 months
- Report at least moderate pain intensity based on a screening pain log
- Report prior clinical evaluation of their pelvic pain by a healthcare professional including at least a superficial pelvic exam
- Willing to refrain from initiating new clinical treatments that may affect their pain during the study period
- Report pelvic pain occurring exclusively with menses or exclusively during sexual intercourse (although candidates with at least some pain between menses or intercourse are still eligible)
- Participation in organized yoga classes or muscle strengthening programs (e.g., Pilates) in the past 4 weeks, or any prior yoga therapy specifically directed at pelvic pain
- Lacking technical requirements to complete intervention classes by video, including no access to broadband internet or a Zoom-compatible device larger than a smartphone [display screen at least 7 inches in diagonal] (although the study team may loan devices to participants from underrepresented backgrounds)
- Currently pregnant (by self-report or screening test), pregnant within the past 12 weeks, or planning pregnancy during the study period
- Diagnosed with an alternate, reversible cause of pelvic pain that is unlikely to respond to yoga and requires another treatment modality (e.g., current pelvic infection or a gynecologic dermatosis)
- Surgery or irradiation to the genital or pelvic structures within the past 12 weeks, or anticipating upcoming surgery or irradiation to these structures during the study period
- Initiation, dose escalation, or weaning of pharmacologic agents that may affect pelvic pain severity in the past 4 weeks, such as analgesics, antidepressants, or anticonvulsants-(however, women on stable doses of these medications for at least 4 weeks will still be eligible)
- Use of formal psychological therapies specifically for pelvic pain (e.g., systematic desensitization, cognitive therapy, relaxation therapy) within 4 weeks of screening, or plans to engage in these therapies during the study period
- Unable to walk up a flight of stairs or at least 2 blocks on level ground (i.e., functional capacity < 4 METs), or unable to get up from a supine to a standing position without assistance
- Participation in another interventional study that might interfere with or confound study procedures, or known conflict with multiple upcoming study intervention class dates
- Inability to understand the informed consent form or fill out questionnaires or complete study interviews
- Any other serious physical or mental issue that, in the opinion of the investigators, would interfere with study participation (e.g., advanced dementia, uncontrolled substance use or serious mental illness, life expectancy <6 months)
Université de Californie à San Francisco- ⚕️National Center for Complementary and Integrative Health (NCCIH)
Université Stanford674 essais cliniques actifs à explorer- 🔬Office of Research on Women's Health (ORWH)
Contact central de l'essai
Contact: Alison Huang, MD, MAS, MPhil, 415-514-8697, [email protected]
Contact: Carolyn Gibson, PhD, 415-205-4108, [email protected]
1 Centres de l'essai dans 1 pays
California
University of California San Francisco, San Francisco, California, 94115, United States
Claudia Vila Manes, Contact, 415-353-4122, [email protected]
Jenny Chen, Contact, 415-353-4122, [email protected]
En recrutement