N/A
N=36
Program to Overcome Pelvic Pain Study
Pelvic Pain · Chronic Pelvic Pain · Recurrent Pelvic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04615247 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: 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. — 14; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Yoga Program (Other); Physical Conditioning Program (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
14; 12 | — |
| SECONDARY Percentage of Screenees Who Are Eventually Randomized |
17; 19 | — |
| SECONDARY Percentage of Randomized Participants Who Drop Out by 8 Weeks |
1; 3 | — |
| SECONDARY Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks |
15; 13 | — |
| SECONDARY Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks |
14; 12 | — |
| SECONDARY Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks |
15; 14 | — |
| SECONDARY Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks |
15; 12 | — |
| SECONDARY Percentage of Participants With Expected Pain Logs Returned at 8 Weeks |
15; 15 | — |
| SECONDARY Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks |
14; 15 | — |
| SECONDARY Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks |
14; 15 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04615247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.