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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Pelvic floor yoga
Physical conditioning
University of California San Francisco
San Francisco, California, United States
RECRUITINGPelvic 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.
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.
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.
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.
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)
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Time frame: After 4 months of intervention instruction and maintenance period.
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.
General interference of pain with daily functioning in women with CPPS, as measured by scores on the PROMIS Pain Interference 4a measure from baseline to 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.
Perceived stress as measured by scores on the 4-item Perceived Stress Scale over the 4-month intervention period
4-month intervention period (2 months of intervention instruction and 2 months of maintenance)
Time frame: After 4 months of intervention instruction and maintenance period.
Sleep quality as measured by scores on the PROMIS Sleep Disturbance Short Form over the 4-month intervention period
4-month intervention period (2 months of intervention instruction and 2 months of maintenance).
Time frame: After 4 months of intervention instruction and maintenance period.
Pelvic problems-related sexual function as measured by scores on the Pelvic Problems Interference subscale of the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) over the 4-month intervention period
4-month intervention period (2 months of intervention instruction and 2 months of maintenance)
Time frame: After 4 months of intervention instruction and maintenance period.