Trial Outcomes & Findings for Program to Overcome Pelvic Pain Study (NCT NCT04615247)
NCT ID: NCT04615247
Last Updated: 2025-03-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
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.
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.
|
Physical Conditioning Program
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
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.
|
Physical Conditioning Program
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Program to Overcome Pelvic Pain Study
Baseline characteristics by cohort
| Measure |
Yoga Program
n=17 Participants
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.
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.
|
Physical Conditioning Program
n=19 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 15.4 • n=93 Participants
|
52.4 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
51.0 years
STANDARD_DEVIATION 13.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants
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.
Outcome measures
| Measure |
Yoga Program
n=17 Participants
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.
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.
|
Physical Conditioning Program
n=19 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
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 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: RandomizationPopulation: Screened Individuals
Percentage of screenees who are eventually randomized
Outcome measures
| Measure |
Yoga Program
n=17 Participants
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.
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.
|
Physical Conditioning Program
n=19 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Screenees Who Are Eventually Randomized
|
17 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants
Percentage of randomized participants who drop out by 8 weeks
Outcome measures
| Measure |
Yoga Program
n=17 Participants
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.
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.
|
Physical Conditioning Program
n=19 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Randomized Participants Who Drop Out by 8 Weeks
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants who did not drop out
Percentage of non-drop-outs completing at least 75% of intervention classes over 8 weeks
Outcome measures
| Measure |
Yoga Program
n=16 Participants
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.
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.
|
Physical Conditioning Program
n=16 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants who did not drop out
Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks
Outcome measures
| Measure |
Yoga Program
n=16 Participants
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.
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.
|
Physical Conditioning Program
n=16 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants who Submitted Self-Efficacy Questionnaire
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.
Outcome measures
| Measure |
Yoga Program
n=15 Participants
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.
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.
|
Physical Conditioning Program
n=16 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants who Evaluated by Consultant
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.
Outcome measures
| Measure |
Yoga Program
n=15 Participants
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.
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.
|
Physical Conditioning Program
n=12 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants who did not drop out
Percentage of participants with expected pain logs returned at 8 weeks
Outcome measures
| Measure |
Yoga Program
n=16 Participants
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.
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.
|
Physical Conditioning Program
n=16 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants who did not drop out
Percentage of participants with expected pain interference questionnaires returned at 8 weeks
Outcome measures
| Measure |
Yoga Program
n=16 Participants
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.
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.
|
Physical Conditioning Program
n=16 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Randomized Participants who did not drop out
Percentage of participants with expected pelvic pain impact measures returned at 8 weeks
Outcome measures
| Measure |
Yoga Program
n=16 Participants
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.
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.
|
Physical Conditioning Program
n=16 Participants
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks
|
14 Participants
|
15 Participants
|
Adverse Events
Yoga Program
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Physical Conditioning Program
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Yoga Program
n=17 participants at risk
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.
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.
|
Physical Conditioning Program
n=19 participants at risk
A low-impact, muscle stretching and strengthening program.
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Aggravated
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Hepatobiliary disorders
Gallstones
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Cold
|
11.8%
2/17 • Number of events 2 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Infections and infestations
Covid-19
|
17.6%
3/17 • Number of events 3 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Ebv Infection
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Shingles
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Injury, poisoning and procedural complications
Knee Dislocation
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Thigh Strain
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Injury, poisoning and procedural complications
Vaccination Adverse Reaction
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
11.8%
2/17 • Number of events 3 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Wrist Pain
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Nervous system disorders
Migraine
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Nervous system disorders
Seizures
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Renal and urinary disorders
Cystitis Interstitial
|
5.9%
1/17 • Number of events 1 • 16 weeks
|
0.00%
0/19 • 16 weeks
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Reproductive system and breast disorders
Pelvic Pain Female
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Reproductive system and breast disorders
Vaginal Pain
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
|
Surgical and medical procedures
Carpal Tunnel Release
|
0.00%
0/17 • 16 weeks
|
5.3%
1/19 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place