Program to Overcome Pelvic Pain Study

Not Applicable

Completed

Conditions: Pelvic Pain
Recurrent Pelvic Pain
Chronic Pelvic Pain

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

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

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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