SBIR-STTR Award

Novel Approach to Personalize and Monitor Therapeutic Training At Home in Chronic Pelvic Pain Management
Award last edited on: 2/8/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NINDS
Total Award Amount
$246,658
Award Phase
1
Solicitation Topic Code
865
Principal Investigator
Nicholas Dias

Company Information

Hillmed Inc

6110 Meadowstream Court
Katy, TX 77450
   (281) 658-1953
   N/A
   www.hillmedgroup.com
Location: Single
Congr. District: 22
County: Harris

Phase I

Contract Number: 1R43HD107727-01A1
Start Date: 8/1/2022    Completed: 7/31/2023
Phase I year
2022
Phase I Amount
$246,658
Chronic pelvic pain (CPP) is a debilitating condition that negatively impacts the social and sexual quality oflife of up to 20% of American women. Pelvic floor muscle (PFM) overactivity is a condition related to myofascialpain present in most CPP patients. Myofascial physical therapy has become the standard pelvic floor muscletraining technique for PFM tenderness and overactivity attributed to CPP. Myofascial physical therapy specificallyaddresses overactive PFMs in CPP patients via manual massage and muscle stretching. PFM pain is amultifactorial dysfunction additionally attributed to postural issues and peripheral sensitization rather than solelymyofascial pain and overactivity. Myofascial physical therapy does not address these posture and movementimpairments, which are also associated with pelvic pain. Even among the specific IC/BPS pain subtype of CPPpatients, only 59% of patients report significant symptom improvement after myofascial physical therapy.Complementarily, movement physical therapy aims to correct postural dysfunction and aberrant movementpatterns that contribute to pelvic pain. A comprehensive pelvic floor muscle training (PFMT) protocol will addressboth the myofascial abnormalities present in the pelvic floor, and the movement and postural abnormalitiesoriginating from the hip, trunk, or leg muscles. Currently, PFMT must be performed as an outpatient physicaltherapy to ensure proper execution of prescribed exercises to correct problematic interactions between the PFMsand specific Hip/Trunk muscles. Furthermore, PFMT is a time-consuming treatment, lasting up to 12 weeks, withup to 10 outpatient visits, leading to adherence issues that negatively affect the response rates. Many biofeedback tools have been developed for home use; however, none of these devices allow forassessing and monitoring the interaction between the PFMs and problematic Hip/Trunk muscles that contributeto CPP. No competent, objective technique or tool is currently available for guiding myofascial and movementpattern training protocol tailored to patients to enable adaptive at-home PFMT for CPP. The PIs havesuccessfully developed 1) a novel vaginal high-density surface EMG technique to reliably and quantitativelyassess PFM overactivity in women with CPP, 2) a novel muscle network analysis technique to reveal the aberrantinteraction between PFMs and Hip/Trunk muscles in women with CPP. Building upon their research findings,the PIs co-invented a novel smartphone-based wireless device, i.e., the CPP HomeTrainer, for the quantitativeand real-time self-monitoring of both PFM activation capacity and inter-muscle interactions between the PFMand Hip/Trunk muscles to enable adaptive PFMT at home. This Phase I project will introduce a prototype of theCPP HomeTrainer device suitable for commercialization after 510(k) clearance. The proposed CPPHomeTrainer offers biofeedback to aid myofascial physical therapy and movement pattern training by tailoringthe protocol to specifically break aberrant interactions between the PFM and problematic Hip/Trunk muscles.

Public Health Relevance Statement:
Project Narrative Chronic pelvic pain (CPP) is a debilitating condition that negatively impacts the social and sexual quality of life of up to 20% of American women. The myofascial physical therapy specifically addresses overactive pelvic floor muscles (PFM)s in CPP patients, and the movement physical therapy corrects postural dysfunction and aberrant movement patterns that also contribute to pelvic pain. Both treatments are time-consuming treatment and require 10 outpatient visits in 12 weeks, which lead to adherence issues that negatively affect the response rates. Current at-home devices only monitor PFM activity. This Phase I project will develop a prototype of a novel smartphone-based wireless device, i.e., the CPP HomeTrainer, for the quantitative and real-time monitoring of both PFM activation capacity and inter-muscle interactions between the PFM and Hip/Trunk muscles to enable adaptive PFMT at home.

Project Terms:

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
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