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Program to Overcome Pelvic Pain Study (POPPY)

Primary Purpose

Pelvic Pain, Chronic Pelvic Pain, Recurrent Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Program
Physical Conditioning Program
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco
  • Stanford University
  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga Program

Physical Conditioning Program

Arm Description

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.

A low-impact, muscle stretching and strengthening program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Screenees Who Are Eventually Randomized
Percentage of screenees who are eventually randomized
Percentage of Randomized Participants Who Drop Out by 8 Weeks
Percentage of randomized participants who drop out by 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
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
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.
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.
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
Percentage of participants with expected pain logs returned at 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
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

Full Information

First Posted
October 28, 2020
Last Updated
June 12, 2023
Sponsor
University of California, San Francisco
Collaborators
Stanford University, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04615247
Brief Title
Program to Overcome Pelvic Pain Study
Acronym
POPPY
Official Title
A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Stanford University, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Chronic Pelvic Pain, Recurrent Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Conditioning Program
Arm Type
Active Comparator
Arm Description
A low-impact, muscle stretching and strengthening program.
Intervention Type
Other
Intervention Name(s)
Yoga Program
Intervention Description
The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.
Intervention Type
Other
Intervention Name(s)
Physical Conditioning Program
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Screenees Who Are Eventually Randomized
Description
Percentage of screenees who are eventually randomized
Time Frame
Randomization
Title
Percentage of Randomized Participants Who Drop Out by 8 Weeks
Description
Percentage of randomized participants who drop out by 8 weeks
Time Frame
8 weeks
Title
Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks
Description
Percentage of non-drop-outs completing at least 75% of intervention classes over 8 weeks
Time Frame
8 weeks
Title
Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks
Description
Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks
Time Frame
8 weeks
Title
Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks
Description
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.
Time Frame
8 weeks
Title
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
Description
Percentage of participants with expected pain logs returned at 8 weeks
Time Frame
8 weeks
Title
Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks
Description
Percentage of participants with expected pain interference questionnaires returned at 8 weeks
Time Frame
8 weeks
Title
Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks
Description
Percentage of participants with expected pelvic pain impact measures returned at 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Huang, MD, MAS, MPhil
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94925
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Program to Overcome Pelvic Pain Study

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