Program to Overcome Pelvic Pain Study

Study Overview
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Brief Summary
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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.

Official Title
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A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women

Conditions
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Pelvic Pain, Chronic Pelvic Pain, Recurrent Pelvic Pain

Intervention / Treatment
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* Other: Yoga Program
* Other: Physical Conditioning Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Program<br>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<br>* The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.<br>|
| Active Comparator: Physical Conditioning Program<br>A low-impact, muscle stretching and strengthening program. | Other: Physical Conditioning Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Screenees Who Are Eventually Randomized | Percentage of screenees who are eventually randomized | Randomization | 
| Percentage of Randomized Participants Who Drop Out by 8 Weeks | 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 | 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 | 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 | 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. | 8 weeks | 
| Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 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. | 8 weeks | 
| Percentage of Participants With Expected Pain Logs Returned at 8 Weeks | Percentage of participants with expected pain logs returned at 8 weeks | 8 weeks | 
| Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks | Percentage of participants with expected pain interference questionnaires returned at 8 weeks | 8 weeks | 
| Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks | Percentage of participants with expected pelvic pain impact measures returned at 8 weeks | 8 weeks |