Pelvic Pain
Conditions
Keywords
Chronic pelvic pain
Brief summary
The researchers will conduct a pilot randomized trial to assess functional changes with two different remote integrative non-pharmacologic interventions for women with chronic pelvic pain (CPP). The study team will compare a novel web-based, cognitive-behavioral program designed for patients with CPP and a commercially available physical activity remote application. The team aims to gather information about differences in sexual function, physical function, pain, and quality of life.
Detailed description
My Pelvic Plan was determined as a medical device under FDA enforcement discretion.
Interventions
DEVICEMy Pelvic Plan
My Pelvic Plan is comprised of a self-guided program that combines education on several individual conditions that often contribute to CPP, and will include instruction on cognitive and behavioral restructuring techniques that can help to manage chronic pelvic pain symptoms.
BEHAVIORALBend
Bend is a highly rated physical activity application that helps guide users through gentle stretching and yoga poses.
Sponsors
Sara Till, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients will be blinded to their group assignment. Study team members involved in outcome assessment will be blinded to group assignment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for a new patient visit with the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain. * Have chronic pelvic pain, defined as moderate to severe pelvic pain that is ≥ 4 on a 0-10 numeric rating scale (worst pain during the day) for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month. * Report moderate to severe sexual dysfunction or sexual restriction on CPP clinic intake questionnaire. This will be defined as the patient indicating one of the following responses to a question that asks them to describe their experience relative to sexual activity: my sex life is nearly normal but is very painful, my sex life is severely restricted by pain, my sex life is nearly absent because of pain, pain prevents any self life at all. * Have access to internet via computer and must have a smartphone * Willing to download and use the Bend application on their smartphone if they are randomized to that intervention * English-language proficiency (current version of the My Pelvic Plan website is in English)
Exclusion criteria
* Pregnancy (at time of screening visit). Participants will be allowed to continue to study if they become pregnant during the study period. * Severe physical impairment precluding participating in internet-based program or remote application (for example, complete blindness or deafness) * Medical condition that precludes low-intensity, short-duration physical activity and gentle stretching, including cerebral palsy, severe hip or knee osteoarthritis, severe heart failure, severe Chronic obstructive pulmonary disease (COPD) requiring oxygen use * Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because \> 3 year interval since last clinic visit).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total score on the Female Sexual Function Index (FSFI) | 8 weeks | This female sexual function index (FSFI) questionnaire calculator evaluates and monitors woman sexual functioning as well as the level of dysfunction. The FSFI ranges in scores from 2-36 where higher scores indicate more disfunction. (0's may indicate no sexual activity in period in question.) |
| PROMIS-29 Profile v2.1 physical function domain score | 8 weeks | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health. |
| PROMIS-29 Profile v2.1 pain interference domain score | 8 weeks | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total score on the Female Sexual Function Index (FSFI) | 4 weeks | This female sexual function index (FSFI) questionnaire calculator evaluates and monitors woman sexual functioning as well as the level of dysfunction. The FSFI ranges in scores from 2-36 where higher scores indicate more disfunction. (0's may indicate no sexual activity in period in question.) |
| PROMIS-29 Profile v2.1 pain interference domain score | 4 weeks | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health. |
| PROMIS-29 Profile v2.1 physical function domain score | 4 weeks | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function. Higher scores indicate more severity/worse health. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSara Till, MD MPH
University of Michigan
Outcome results
None listed