Program to Overcome Pelvic Pain Study

NCT ID: NCT04615247

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2022-08-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Yoga Program

Intervention Type: OTHER

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

Physical Conditioning Program

A low-impact, muscle stretching and strengthening program.

Group Type: ACTIVE_COMPARATOR

Physical Conditioning Program

Intervention Type: 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.

Interventions

Yoga Program

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

Intervention Type: OTHER

Physical Conditioning Program

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Huang, MD, MAS, MPhil

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

Oakland, California, United States

Stanford University

Palo Alto, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39723995 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34AT010356

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-29762

Identifier Type: -

Identifier Source: org_study_id