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Program to Overcome Pelvic Pain With Yoga (POPPY)

Primary Purpose

Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring Pelvic Pain, Genital Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women aged 21 years or older who report difficulties with pelvic or genital pain for at least 6 months
  2. Report that their chronic pelvic or genital pain has had an adverse effect on their interest in or ability to enjoy sexual activity
  3. Report an eligible average daily pain intensity score after completion of a Daily Pain Log for one week prior to baseline
  4. Have an established primary care or gynecologic healthcare provider (to facilitate medical follow-up of any health issues detected incidentally in the study or adverse events that develop during the study)
  5. Report prior clinical evaluation of their pelvic or genital pain by a health care professional including at least a superficial pelvic exam
  6. Willing to refrain from initiating other new clinical treatments that may affect their pelvic or genital pain during the study period (6 weeks)

Exclusion Criteria:

  1. Participation in organized yoga classes in the past 1 month, or any prior yoga therapy directed specifically at pelvic or genital pain (regardless of timing)
  2. Currently pregnant (by self-report or screening test), pregnant within the past 6 months, planning pregnancy during the study, or unwilling to use contraception (if not postmenopausal) during the study
  3. Diagnosed with an alternate cause of pain that is unlikely to respond to yoga and requires another treatment modality, such as pelvic infection or a gynecologic dermatosis
  4. Surgery to the vulva, vagina, cervix, or pelvic organs within 6 months of screening, or any prior history of cancer or irradiation to these structures
  5. Initiation of or dose escalation of pharmacologic agents that may affect pelvic or genital pain in the past 1 month (e.g., antidepressants, anticonvulsants, anxiolytics)-women on stable dose for >1 month are eligible
  6. Use of formal psychological therapies specifically for pelvic or genital pain (e.g., systematic desensitization, sex therapy, cognitive therapy, relaxation therapy) within 1 month of screening
  7. 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
  8. 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 in <10 seconds
  9. Currently involved in a malpractice suit or other litigation specifically related to pelvic or genital pain
  10. Participation in another interventional study that might interfere with or confound study procedures, inability to sign an informed consent or fill out questionnaires, or conflict with available yoga class dates

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga Therapy Group

Arm Description

Participants will attend twice-weekly group yoga classes and be instructed to practice yoga at home one additional hour a week, using a written manual.

Outcomes

Primary Outcome Measures

Change from baseline in severity of pelvic pain after yoga therapy program.
Self-reported daily pain severity, as rated by Daily Pain Log (scale from 0-10).

Secondary Outcome Measures

Change in baseline sexual functioning after yoga therapy program.
We will use standard questionnaires to assess changes in sexual function.
Change in baseline quality of life after yoga therapy program.
We will use standard questionnaires to assess changes in overall quality of life.

Full Information

First Posted
October 1, 2014
Last Updated
September 30, 2016
Sponsor
University of California, San Francisco
Collaborators
Patty Brisben Foundation For Women's Sexual Health
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1. Study Identification

Unique Protocol Identification Number
NCT02261740
Brief Title
Program to Overcome Pelvic Pain With Yoga
Acronym
POPPY
Official Title
Program to Overcome Pelvic Pain With Yoga (POPPY) (a.k.a., Development of a Therapeutic Yoga Program for Female Genito-Pelvic Pain)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Patty Brisben Foundation For Women's Sexual Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report persistent or recurrent pelvic or genital pain for at least 6 months that interferes with sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel. Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that have been carefully selected for their potential to improve women's genito-pelvic pain and practice yoga at home one additional hour a week. The investigators will evaluate changes in the severity and impact of women's pain using validated questionnaires and diaries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
Keywords
Pelvic Pain, Genital Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Therapy Group
Arm Type
Experimental
Arm Description
Participants will attend twice-weekly group yoga classes and be instructed to practice yoga at home one additional hour a week, using a written manual.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Therapy
Intervention Description
A 90-minute orientation session led by the yoga class instructors, followed by 90-minute group yoga classes twice weekly for 6 weeks. Classes will be led by an experienced instructor. Women will also be taught to avoid any habits that may worsen their genito-pelvic pain (e.g., straining their pelvic floor muscles). Participants will also be asked to practice yoga at home an additional hour per week throughout the 6-week yoga therapy program. Participants will be given a detailed written manual to use for home practice.
Primary Outcome Measure Information:
Title
Change from baseline in severity of pelvic pain after yoga therapy program.
Description
Self-reported daily pain severity, as rated by Daily Pain Log (scale from 0-10).
Time Frame
Baseline to 6-Weeks
Secondary Outcome Measure Information:
Title
Change in baseline sexual functioning after yoga therapy program.
Description
We will use standard questionnaires to assess changes in sexual function.
Time Frame
Baseline, 6-Weeks
Title
Change in baseline quality of life after yoga therapy program.
Description
We will use standard questionnaires to assess changes in overall quality of life.
Time Frame
Baseline, 6-Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 21 years or older who report difficulties with pelvic or genital pain for at least 6 months Report that their chronic pelvic or genital pain has had an adverse effect on their interest in or ability to enjoy sexual activity Report an eligible average daily pain intensity score after completion of a Daily Pain Log for one week prior to baseline Have an established primary care or gynecologic healthcare provider (to facilitate medical follow-up of any health issues detected incidentally in the study or adverse events that develop during the study) Report prior clinical evaluation of their pelvic or genital pain by a health care professional including at least a superficial pelvic exam Willing to refrain from initiating other new clinical treatments that may affect their pelvic or genital pain during the study period (6 weeks) Exclusion Criteria: Participation in organized yoga classes in the past 1 month, or any prior yoga therapy directed specifically at pelvic or genital pain (regardless of timing) Currently pregnant (by self-report or screening test), pregnant within the past 6 months, planning pregnancy during the study, or unwilling to use contraception (if not postmenopausal) during the study Diagnosed with an alternate cause of pain that is unlikely to respond to yoga and requires another treatment modality, such as pelvic infection or a gynecologic dermatosis Surgery to the vulva, vagina, cervix, or pelvic organs within 6 months of screening, or any prior history of cancer or irradiation to these structures Initiation of or dose escalation of pharmacologic agents that may affect pelvic or genital pain in the past 1 month (e.g., antidepressants, anticonvulsants, anxiolytics)-women on stable dose for >1 month are eligible Use of formal psychological therapies specifically for pelvic or genital 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 in <10 seconds Currently involved in a malpractice suit or other litigation specifically related to pelvic or genital pain Participation in another interventional study that might interfere with or confound study procedures, inability to sign an informed consent or fill out questionnaires, or conflict with available yoga class dates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Huang, MD, MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Program to Overcome Pelvic Pain With Yoga

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