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Program to Overcome Pelvic Pain Study (POPPY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04615247
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
Stanford University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Pain Chronic Pelvic Pain Recurrent Pelvic Pain Other: Yoga Program Other: Physical Conditioning Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Active Comparator: Physical Conditioning Program
A low-impact, muscle stretching and strengthening program.
Other: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of screenees who are eventually randomized [ Time Frame: Randomization ]
    Percentage of screenees who are eventually randomized

  2. Percentage of randomized participants who drop out by 8 weeks [ Time Frame: 8 weeks ]
    Percentage of randomized participants who drop out by 8 weeks

  3. 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 intervention classes over 8 weeks

  4. Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks [ Time Frame: 8 weeks ]
    Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks

  5. Percentage of participants with at least moderate self-efficacy in performing postures/exercises at 8 weeks [ Time Frame: 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.

  6. Percentage of participants rated by a consultant as being at least moderately competent in performing postures/exercises at 8 weeks [ Time Frame: 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.

  7. Percentage of expected pain logs returned at 8 weeks [ Time Frame: 8 weeks ]
    Percentage of expected pain logs returned at 8 weeks

  8. Percentage of expected pain interference questionnaires returned at 8 weeks [ Time Frame: 8 weeks ]
    Percentage of expected pain interference questionnaires returned at 8 weeks

  9. Percentage of expected pelvic pain impact measures returned at 8 weeks [ Time Frame: 8 weeks ]
    Percentage of expected pelvic pain impact measures returned at 8 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615247


Contacts
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Contact: Alison Huang, MD, MAS, MPhil 415-514-8697 alison.huang@ucsf.edu
Contact: Ann Chang 415-353-9782 ann.chang@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
Oakland, California, United States, 94612
Contact: Sarah Chatfield    415-885-7547    sarah.chatfield@ucsf.edu   
Principal Investigator: Alison Huang, MD         
Stanford University Not yet recruiting
Palo Alto, California, United States, 94305
Contact: Kathryn Batham    650-724-7826    kbatham@stanford.edu   
Principal Investigator: Leslee Subak, MD         
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94925
Contact: Traci Plaut    415-885-7547    traci.plaut@ucsf.edu   
Principal Investigator: Alison Huang, MD         
Sponsors and Collaborators
University of California, San Francisco
Stanford University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Alison Huang, MD, MAS, MPhil University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04615247    
Other Study ID Numbers: 19-29762
R34AT010356 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations