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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT010356 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Physical Conditioning Program | Active Comparator | A low-impact, muscle stretching and strengthening program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga Program | Other | The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Screenees Who Are Eventually Randomized | Percentage of screenees who are eventually randomized | Randomization |
| Percentage of Randomized Participants Who Drop Out by 8 Weeks | Percentage of randomized participants who drop out by 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Huang, MD, MAS, MPhil | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Oakland | California | 94612 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39723995 | Derived | 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. |
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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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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga Program | 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. Yoga Program: The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function. |
| FG001 | Physical Conditioning Program | A low-impact, muscle stretching and strengthening program. Physical Conditioning Program: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Yoga Program | 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. Yoga Program: The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Randomized Participants | Posted | Count of Participants | Participants | 8 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga Program | 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. Yoga Program: The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Aggravated | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Huang, MD | Principal Investigator | 415-353-7900 | alison.huang@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2021 | May 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Physical Conditioning Program | Other | 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. |
|
| 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 | 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 | 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. | 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. | 8 weeks |
| Percentage of Participants With Expected Pain Logs Returned at 8 Weeks | Percentage of participants with expected pain logs returned at 8 weeks | 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 | 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 | 8 weeks |
| Palo Alto |
| California |
| 94305 |
| United States |
| University of California, San Francisco | San Francisco | California | 94925 | United States |
| BG001 | Physical Conditioning Program | A low-impact, muscle stretching and strengthening program. Physical Conditioning Program: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Physical Conditioning Program | A low-impact, muscle stretching and strengthening program. Physical Conditioning Program: 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. |
|
|
| Secondary | Percentage of Screenees Who Are Eventually Randomized | Percentage of screenees who are eventually randomized | Screened Individuals | Posted | Count of Participants | Participants | Randomization |
|
|
|
| Secondary | Percentage of Randomized Participants Who Drop Out by 8 Weeks | Percentage of randomized participants who drop out by 8 weeks | Randomized Participants | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | 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 | Randomized Participants who did not drop out | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | 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 | Randomized Participants who did not drop out | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | 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. | Randomized Participants who Submitted Self-Efficacy Questionnaire | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | 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. | Randomized Participants who Evaluated by Consultant | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Percentage of Participants With Expected Pain Logs Returned at 8 Weeks | Percentage of participants with expected pain logs returned at 8 weeks | Randomized Participants who did not drop out | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks | Percentage of participants with expected pain interference questionnaires returned at 8 weeks | Randomized Participants who did not drop out | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | 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 | Randomized Participants who did not drop out | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 14 |
| 17 |
| EG001 | Physical Conditioning Program | A low-impact, muscle stretching and strengthening program. Physical Conditioning Program: 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. | 0 | 19 | 0 | 19 | 17 | 19 |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gallstones | Hepatobiliary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cold | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Ebv Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
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| Shingles | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
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| Knee Dislocation | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Thigh Strain | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Vaccination Adverse Reaction | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
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| Low Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Muscle Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Wrist Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Seizures | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
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| Cystitis Interstitial | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pelvic Pain Female | Reproductive system and breast disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Vaginal Pain | Reproductive system and breast disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Carpal Tunnel Release | Surgical and medical procedures | MedDRA 22.1 | Non-systematic Assessment |
|
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