Clinical trial NCT04615247: Program to Overcome Pelvic Pain Study
Official title: A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Chronic Pelvic Pain
Recurrent Pelvic Pain
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-11-04
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of Screenees Who Are Eventually Randomized
timeFrame: Randomization
measure: Percentage of Randomized Participants Who Drop Out by 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: University of California, San Francisco
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alison Huang, MD, MAS, MPhil
role: PRINCIPAL_INVESTIGATOR
References: