Chronic Pelvic Pain, Pelvic Pain, Recurrent Pelvic Pain
Conditions
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.
Interventions
OTHERYoga Program
The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.
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.
Sponsors
Stanford University
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Randomized Participants Who Drop Out by 8 Weeks | 8 weeks | Percentage of randomized participants who drop out by 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 intervention classes over 8 weeks |
| Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks | 8 weeks | Percentage of non-drop-outs completing at least 75% of home intervention practice over 8 weeks |
| Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks | 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. |
| Percentage of Screenees Who Are Eventually Randomized | Randomization | Percentage of screenees who are eventually randomized |
| Percentage of Participants With Expected Pain Logs Returned at 8 Weeks | 8 weeks | Percentage of participants with expected pain logs returned at 8 weeks |
| Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks | 8 weeks | Percentage of participants with expected pain interference questionnaires returned at 8 weeks |
| Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks | 8 weeks | Percentage of participants with expected pelvic pain impact measures returned at 8 weeks |
| Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 19 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Yoga Program | Total | Physical Conditioning Program |
|---|---|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 15.4 | 51.0 years STANDARD_DEVIATION 13.9 | 52.4 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 28 Participants | 16 Participants |
| Region of Enrollment United States | 17 Participants | 36 Participants | 19 Participants |
| Sex: Female, Male Female | 17 Participants | 36 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 19 |
| other Total, other adverse events | 14 / 17 | 17 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 19 |
Outcome results
Primary
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.
Time frame: 8 weeks
Population: Randomized Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | 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 |
| Physical Conditioning Program | 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. | 12 Participants |
Secondary
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
Time frame: 8 weeks
Population: Randomized Participants who did not drop out
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks | 14 Participants |
| Physical Conditioning Program | Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks | 12 Participants |
Secondary
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
Time frame: 8 weeks
Population: Randomized Participants who did not drop out
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks | 15 Participants |
| Physical Conditioning Program | Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks | 13 Participants |
Secondary
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.
Time frame: 8 weeks
Population: Randomized Participants who Evaluated by Consultant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks | 15 Participants |
| Physical Conditioning Program | Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks | 12 Participants |
Secondary
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.
Time frame: 8 weeks
Population: Randomized Participants who Submitted Self-Efficacy Questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks | 15 Participants |
| Physical Conditioning Program | Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks | 14 Participants |
Secondary
Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks
Percentage of participants with expected pain interference questionnaires returned at 8 weeks
Time frame: 8 weeks
Population: Randomized Participants who did not drop out
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks | 14 Participants |
| Physical Conditioning Program | Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks | 15 Participants |
Secondary
Percentage of Participants With Expected Pain Logs Returned at 8 Weeks
Percentage of participants with expected pain logs returned at 8 weeks
Time frame: 8 weeks
Population: Randomized Participants who did not drop out
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Participants With Expected Pain Logs Returned at 8 Weeks | 15 Participants |
| Physical Conditioning Program | Percentage of Participants With Expected Pain Logs Returned at 8 Weeks | 15 Participants |
Secondary
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
Time frame: 8 weeks
Population: Randomized Participants who did not drop out
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks | 14 Participants |
| Physical Conditioning Program | Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks | 15 Participants |
Secondary
Percentage of Randomized Participants Who Drop Out by 8 Weeks
Percentage of randomized participants who drop out by 8 weeks
Time frame: 8 weeks
Population: Randomized Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Randomized Participants Who Drop Out by 8 Weeks | 1 Participants |
| Physical Conditioning Program | Percentage of Randomized Participants Who Drop Out by 8 Weeks | 3 Participants |
Secondary
Percentage of Screenees Who Are Eventually Randomized
Percentage of screenees who are eventually randomized
Time frame: Randomization
Population: Screened Individuals
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Yoga Program | Percentage of Screenees Who Are Eventually Randomized | 17 Participants |
| Physical Conditioning Program | Percentage of Screenees Who Are Eventually Randomized | 19 Participants |