Program to Overcome Pelvic Pain Study

Not Applicable

Completed

• Conditions: Pelvic Pain; Recurrent Pelvic Pain; Chronic Pelvic Pain
• Interventions: Other: Yoga Program; Other: Physical Conditioning Program

• Registration Number: NCT04615247
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-11-04
• Study Start: 2020-11-30
• Primary Completion: 2022-05-25
• Study Completion: 2022-08-24
• Results First Submitted: 2023-05-17
• Results First Submitted QC: 2023-05-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-12
• Results First Posted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga Program	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.
Physical Conditioning Program	Physical Conditioning Program	A low-impact, muscle stretching and strengthening program.

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Percentage of Screenees Who Are Eventually Randomized	Randomization	Percentage of screenees who are eventually randomized
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 intervention classes over 8 weeks
Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks	8 weeks	Percentage of participants with expected pelvic pain impact measures returned at 8 weeks
Percentage of Randomized Participants Who Drop Out by 8 Weeks	8 weeks	Percentage of randomized participants who drop out by 8 weeks
Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks	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.
Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks	8 weeks	Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks
Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks	8 weeks	Percentage of participants with expected pain interference questionnaires returned at 8 weeks
Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks	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.
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks	8 weeks	Percentage of participants with expected pain logs returned at 8 weeks

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States