Pelvic PainPOPPYNCT04615247
Program to Overcome Pelvic Pain Study
A study testing Yoga Program and Physical Conditioning Program in people with Pelvic Pain and Chronic Pelvic Pain, run by University of California, San Francisco at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Pain, Chronic Pelvic Pain, Recurrent Pelvic Pain
- What is being tested?
- Yoga Program and Physical Conditioning Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Nov 2020to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, San Francisco
Oakland, California, 94612
Stanford University
Palo Alto, California, 94305
University of California, San Francisco
San Francisco, California, 94925
About this study
Official title: 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.
- Conditions
- Pelvic Pain, Chronic Pelvic Pain, Recurrent Pelvic Pain
- Being tested
- Yoga Program, Physical Conditioning Program
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ProgramOther
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Program | Experimental | 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. Receives: Other: Yoga Program |
| Physical Conditioning Program | Active comparator | A low-impact, muscle stretching and strengthening program. Receives: Other: Physical Conditioning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (9)
Percentage of Screenees Who Are Eventually Randomized
Percentage of screenees who are eventually randomized
Measured: Randomization
Percentage of Randomized Participants Who Drop Out by 8 Weeks
Percentage of randomized participants who drop out by 8 weeks
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 8 weeks
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
Percentage of participants with expected pain logs returned at 8 weeks
Measured: 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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start30 Nov 2020
- Primary completion25 May 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Alison Huang, MD, MAS, MPhil, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615247
- Sponsor's protocol ID
- 19-29762
- Other IDs
- R34AT010356
- Acronym
- POPPY
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2020
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Huang AJ, Subak LL, Rowen TS, Schembri M, Raghunathan H, Gibson C, Pawlowsky S, Cheng J, Chao MT. A Multisite Randomized Feasibility Trial of a Remotely Delivered Pelvic Yoga Program for Women with Chronic Pelvic Pain Syndrome. J Integr Complement Med. 2025 May;31(5):483-492. doi: 10.1089/jicm.2024.0682. Epub 2024 Dec 26.
PubMed 39723995
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women
- ClinicalTrials.gov ID
- NCT04615247
- Acronym / sponsor ID
- POPPY / 19-29762
- Conditions
- Pelvic Pain, Chronic Pelvic Pain, Recurrent Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Stanford University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Program | Experimental | Other: Yoga ProgramThe 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. |
| Physical Conditioning Program | Active comparator | Other: Physical Conditioning ProgramA low-impact, muscle stretching and strengthening program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga ProgramThe yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function. | Other | Yoga Program |
| Physical Conditioning ProgramThe 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. | Other | Physical Conditioning Program |
Primary outcome
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.
9 secondary outcomes
Percentage of Screenees Who Are Eventually Randomized
Time frame: Randomization
Percentage of Randomized Participants Who Drop Out by 8 Weeks
Time frame: 8 weeks
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 Home Intervention Practice Over 8 Weeks
Time frame: 8 weeks
Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks
Time frame: 8 weeks
Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks
Time frame: 8 weeks
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
Time frame: 8 weeks
Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks
Time frame: 8 weeks
Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39723995Huang AJ, Subak LL, Rowen TS, Schembri M, Raghunathan H, Gibson C, Pawlowsky S, Cheng J, Chao MT. A Multisite Randomized Feasibility Trial of a Remotely Delivered Pelvic Yoga Program for Women with Chronic Pelvic Pain Syndrome. J Integr Complement Med. 2025 May;31(5):483-492. doi: 10.1089/jicm.2024.0682. Epub 2024 Dec 26.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Huang, MD, MAS, MPhil principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Program and Physical Conditioning Program in people with Pelvic Pain and Chronic Pelvic Pain, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.