National Program to Overcome Pelvic Pain studY (POPPY)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pelvic floor yoga
Other interventionPelvic floor yoga
Physical conditioning
Other interventionPhysical conditioning
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Pelvic floor yoga programExperimental treatment 1 intervention
Group B: Physical conditioning program (Skeletal muscle stretching and strengthening program)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
After 4 months of intervention instruction and maintenance period.2
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)
Time frame
After 4 months of intervention instruction and maintenance period.Secondary outcomes
1
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)
Time frame
After 4 months of intervention instruction and maintenance period.2
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)
Time frame
After 4 months of intervention instruction and maintenance period.3
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)
Time frame
After 4 months of intervention instruction and maintenance period.4
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)
Time frame
After 4 months of intervention instruction and maintenance period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Stanford University
Collaborator
Office of Research on Women's Health (ORWH)
Collaborator
Source ClinicalTrials.gov