Comparing Integrative Interventions for Chronic Pelvic Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Total score on the Female Sexual Function Index (FSFI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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 Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts 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).
Arms & Interventions
Group 1- My Pelvic Plan
Patients will be randomized to receive one of two non-pharmacologic interventions. Group 1 will receive access to a novel web-based, cognitive behavioral program.
Intervention: My Pelvic Plan (Device)
Group 2- Bend
Patients will be randomized to receive one of two non-pharmacologic interventions. Group 2 will receive a subscription to a commercially available remote application.
Intervention: Bend (Behavioral)
Outcomes
Primary Outcomes
Total score on the Female Sexual Function Index (FSFI)
Time Frame: 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
Time Frame: 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
Time Frame: 8 weeks
PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including pain interference. Higher scores indicate more severity/worse health.
Secondary Outcomes
- Total score on the Female Sexual Function Index (FSFI)(4 weeks)
- PROMIS-29 Profile v2.1 pain interference domain score(4 weeks)
- PROMIS-29 Profile v2.1 physical function domain score(4 weeks)
Investigators
Sara Till, MD, MPH
Assistant Professor of Obstetrics and Gynecology
University of Michigan