Program to Overcome Pelvic Pain Study

NCT04615247 | Completed Results DMC

• 2 other identifiers: 19-29762R34AT010356
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Pelvic Pain; Chronic Pelvic Pain; Recurrent Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Percentage of Screenees Who Are Eventually Randomized

  Randomization

• Percentage of Randomized Participants Who Drop Out by 8 Weeks

  8 weeks

• 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 Home Intervention Practice Over 8 Weeks

  8 weeks

• Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks

  8 weeks

Study Arms (2)

Yoga Program

EXPERIMENTAL

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.

Other: Yoga Program

Physical Conditioning Program

ACTIVE COMPARATOR

A low-impact, muscle stretching and strengthening program.

Other: Physical Conditioning Program

Interventions

Yoga Program OTHER

The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.

Yoga Program

Physical Conditioning Program OTHER

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.

Physical Conditioning Program

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (3)

University of California, San Francisco

Oakland, California, 94612, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

University of California, San Francisco

San Francisco, California, 94925, United States

Location

Related Publications (1)

• Huang AJ, Subak LL, Rowen TS, Schembri M, Raghunathan H, Gibson C, Pawlowsky S, Cheng J, Chao MT. A Multisite Randomized Feasibility Trial of a Remotely Delivered Pelvic Yoga Program for Women with Chronic Pelvic Pain Syndrome. J Integr Complement Med. 2025 May;31(5):483-492. doi: 10.1089/jicm.2024.0682. Epub 2024 Dec 26.

  PMID: 39723995 DERIVED

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alison Huang, MD
• Organization: Principal Investigator

alison.huang@ucsf.edu

415-353-7900

Study Officials

• Alison Huang, MD, MAS, MPhil

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: November 30, 2020
• Primary Completion: May 25, 2022
• Study Completion: August 24, 2022
• Last Updated: March 30, 2025
• Results First Posted: June 13, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: To gain access, data requestors will be asked to sign a data access agreement. In addition to signing a data access agreement, data requestors seeking to use trial data to generate new publications or presentations will be asked to submit a publication/presentation proposal that will be reviewed by the members of the trial steering committee, made up of the principal and co-investigators, for overlap with existing publication/presentation proposals as well as methodological appropriateness.

Locations

US (3)