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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT012461 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Stanford University | OTHER |
| Office of Research on Women's Health (ORWH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic floor yoga program | Experimental | Instruction in the therapeutic yoga intervention will be delivered through 75-minute group classes occurring twice weekly for a 2-month (8-week) intervention instruction period, involving a trained instructor and an expected 6-10 students (a.k.a. participants) using a secure Zoom videoconference platform. Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. |
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| Physical conditioning program (Skeletal muscle stretching and strengthening program) | Active Comparator | The physical conditioning program (skeletal muscle stretching and strengthening program) intervention will begin with a group orientation led by a physical trainer, who will provide an overview of the program. This will be followed by 75-minute twice-weekly group classes, each with an expected class size of 6-10 participants, led by the same physical trainer who has received study-specific training from the study's expert physical therapist consultant, and using a secure Zoom videoconference platform. Following the 8-week intervention instruction period, additional optional once-weekly, 75-minute drop-in group classes will be offered over an additional 8-week intervention maintenance period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor yoga | Other | Pelvic floor yoga |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | After 4 months of intervention instruction and maintenance period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | After 4 months of intervention instruction and maintenance period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Huang, MD, MAS, MPhil | Contact | 415-514-8697 | Alison.Huang@ucsf.edu | |
| Carolyn Gibson, PhD | Contact | 415-205-4108 | carolyn.gibson@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alison Huang, MD | University of California, San Francisco | Principal Investigator |
| Carolyn Gibson, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94115 | United States |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Physical conditioning |
| Other |
Physical conditioning |
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| 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) | 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) | 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) | 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. | 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) | 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). | 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) | After 4 months of intervention instruction and maintenance period. |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |