Program to Overcome Pelvic Pain Study

Pelvic Pain Clinical Trial

— POPPY  

Official title:

A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615247
• Other study ID #: 19-29762
• Secondary ID: R34AT010356
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: August 24, 2022

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 24, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Pain
• Recurrent Pelvic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	Oakland	California
United States	Stanford University	Palo Alto	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks
Secondary	Percentage of Screenees Who Are Eventually Randomized	Percentage of screenees who are eventually randomized	Randomization
Secondary	Percentage of Randomized Participants Who Drop Out by 8 Weeks	Percentage of randomized participants who drop out by 8 weeks	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	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	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.	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.	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	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	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	8 weeks