Program to Overcome Pelvic Pain Study (POPPY)

A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women

To refine and evaluate the feasibility of procedures for a future full-scale efficacy trial of a group-based therapeutic yoga intervention versus physical conditioning (stretching and strengthening) intervention for women with chronic pelvic pain.

Study Overview

• Status: Completed
• Conditions: Pelvic Pain; Chronic Pelvic Pain; Recurrent Pelvic Pain
• Intervention / Treatment: Other: Yoga Program; Other: Physical Conditioning Program

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • University of California, San Francisco
    • Palo Alto, California, United States, 94305
      • Stanford University
    • San Francisco, California, United States, 94925
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 18 years or older who report chronic or recurrent pelvic pain for at least 6 months
• Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale) on a screening 7-day pain log
• Report prior clinical evaluation of 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

Exclusion Criteria:

• Report pelvic pain occurring exclusively with menses or exclusively during sexual intercourse (note that women 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 month, or prior yoga therapy specifically directed a pelvic pain
• Currently pregnant (by self-report or screening test), pregnant within the past 6 months, or planning pregnancy
• Diagnosed with an alternate, reversible cause of pain that is unlikely to respond to yoga and requires another treatment modality (e.g., current pelvic infection or a gynecologic dermatosis)
• Initiation, dose escalation, or weaning of pharmacologic agents that may affect pelvic pain severity in the past 1 month (e.g., pain medications, antidepressants, anticonvulsants)-note that women on stable doses will be eligible
• Surgery to the genital or pelvic structures within 3 months, or prior cancer or irradiation to these structures
• Use of formal psychological therapies specifically for pelvic pain (e.g., systematic desensitization, sex therapy, cognitive therapy, relaxation therapy) within 1 month of screening
• Use of formal behavioral therapies for pelvic or genital pain (e.g., pelvic floor rehabilitation or biofeedback performed by a certified healthcare practitioner) within 1 month of screening
• 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
• Known conflict with multiple available intervention class dates
• Inability to sign an informed consent or fill out questionnaires or complete study interviews in English, or lacking technical requirements to complete intervention classes or study visits by video

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga Program; The study yoga intervention is designed to provide instruction and practice in selected yoga postures and techniques chosen by an expert panel for their potential to improve pelvic pain in women.	Other: Yoga Program; The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.
Active Comparator: Physical Conditioning Program; A low-impact, muscle stretching and strengthening program.	Other: Physical Conditioning Program; The physical conditioning program will focus on a core set of exercises designed to improve physical function and emotional well-being in order to improve management of chronic pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Randomized Participants Who: a) Are Retained at 8 Weeks, b) Attend at Least 75% of Intervention Classes, c) Demonstrate at Least Moderate Intervention Self-efficacy, and d) Provide Pain Outcomes Data at 8 Weeks.	Number of randomized participants who: a) are retained at 8 weeks, b) attend at least 75% of intervention classes, c) demonstrate at least moderate intervention self-efficacy, and d) provide pain outcomes data at 8 weeks.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Screenees Who Are Eventually Randomized	Percentage of screenees who are eventually randomized	Randomization
Percentage of Randomized Participants Who Drop Out by 8 Weeks	Percentage of randomized participants who drop out by 8 weeks	8 weeks
Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks	Percentage of non-drop-outs completing at least 75% of intervention classes over 8 weeks	8 weeks
Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks	Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks	8 weeks
Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks	Participants will rate their self-confidence in performing each posture/exercise on a 5-point Likert scale (5-extremely, 4-very, 3-moderately, 2-somewhat, and 1-not at all confident. The percentage of participants with an average self-confidence score of 3 or higher across postures/exercises at 8 weeks will be calculated.	8 weeks
Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks	Expert consultants will observe and rate participants' success in performing each posture/exercise on a 5-point Likert scale (5-extremely, 4-very, 3-moderately, 2-somewhat, and 1-not at all confident. The percentage of participants with an average competence rating of 3 or higher across postures/exercises at 8 weeks will be calculated.	8 weeks
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks	Percentage of participants with expected pain logs returned at 8 weeks	8 weeks
Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks	Percentage of participants with expected pain interference questionnaires returned at 8 weeks	8 weeks
Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks	Percentage of participants with expected pelvic pain impact measures returned at 8 weeks	8 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Stanford University; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Alison Huang, MD, MAS, MPhil, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: 19-29762; R34AT010356 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Starting no later than 6 months following publication of the main trial results (including on-line publication), the investigative team will make publically available de-identified individual participant data that underlie the results reported in the publication. This will include data about the baseline characteristics of the study participants and any primary or secondary trial outcomes presented in the publication.
• IPD Sharing Access Criteria: To gain access, data requestors will be asked to sign a data access agreement. In addition to signing a data access agreement, data requestors seeking to use trial data to generate new publications or presentations will be asked to submit a publication/presentation proposal that will be reviewed by the members of the trial steering committee, made up of the principal and co-investigators, for overlap with existing publication/presentation proposals as well as methodological appropriateness.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No