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Completed

NCT Number: NCT04615247

Program to Overcome Pelvic Pain Study

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, Oakland, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

yoga program

Other

The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.

Physical Conditioning Program

Other

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.

Primary outcomes

  1. 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.

    Time frame: 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.

Secondary outcomes

  1. Percentage of Screenees Who Are Eventually Randomized

    Time frame: Randomization

    Percentage of screenees who are eventually randomized

  2. Percentage of Randomized Participants Who Drop Out by 8 Weeks

    Time frame: 8 weeks

    Percentage of randomized participants who drop out by 8 weeks

  3. Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks

    Time frame: 8 weeks

    Percentage of non-drop-outs completing at least 75% of intervention classes over 8 weeks

  4. Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks

    Time frame: 8 weeks

    Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks

  5. Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks

    Time frame: 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.

  6. Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks

    Time frame: 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.

  7. Percentage of Participants With Expected Pain Logs Returned at 8 Weeks

    Time frame: 8 weeks

    Percentage of participants with expected pain logs returned at 8 weeks

  8. Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks

    Time frame: 8 weeks

    Percentage of participants with expected pain interference questionnaires returned at 8 weeks

  9. Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks

    Time frame: 8 weeks

    Percentage of participants with expected pelvic pain impact measures returned at 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Stanford University

Registry information

Official study title

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

Acronym: POPPY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2020
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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