SBIR/STTR Research Award

Novel Approach to Personalize and Monitor Therapeutic Training At Home in Chronic Pelvic Pain Management

Award identifier 8cebef2e60fd8fbcc532f5ca16d71d56d084e8b6fae3670fbc8c447c7255aa4cAwarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$246,658

Program and phase

SBIR · Phase I

Award year

2022

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
HILLMED INC
Proposal award date
2022-08-01
Contract end date
2023-07-31
UEI
PTM4VFBPWBJ4
Solicitation number
NS20-011
Topic code
NICHD

Research abstract

AbstractChronic pelvic pain (CPP) is a debilitating condition that negatively impacts the social and sexual quality of life of up to 20% of American women. Pelvic floor muscle (PFM) overactivity is a condition related to myofascial pain present in most CPP patients. Myofascial physical therapy has become the standard pelvic floor muscle training technique for PFM tenderness and overactivity attributed to CPP. Myofascial physical therapy specifically addresses overactive PFMs in CPP patients via manual massage and muscle stretching. PFM pain is a multifactorial dysfunction additionally attributed to postural issues and peripheral sensitization rather than solely myofascial pain and overactivity. Myofascial physical therapy does not address these posture and movement impairments, which are also associated with pelvic pain. Even among the specific IC/BPS pain subtype of CPP patients, only 59% of patients report significant symptom improvement after myofascial physical therapy. Complementarily, movement physical therapy aims to correct postural dysfunction and aberrant movement patterns that contribute to pelvic pain. A comprehensive pelvic floor muscle training (PFMT) protocol will address both the myofascial abnormalities present in the pelvic floor, and the movement and postural abnormalities originating from the hip, trunk, or leg muscles. Currently, PFMT must be performed as an outpatient physical therapy to ensure proper execution of prescribed exercises to correct problematic interactions between the PFMs and specific Hip/Trunk muscles. Furthermore, PFMT is a time-consuming treatment, lasting up to 12 weeks, with up 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 for assessing and monitoring the interaction between the PFMs and problematic Hip/Trunk muscles that contribute to CPP. No competent, objective technique or tool is currently available for guiding myofascial and movement pattern training protocol tailored to patients to enable adaptive at-home PFMT for CPP. The PIs have successfully developed 1) a novel vaginal high-density surface EMG technique to reliably and quantitatively assess PFM overactivity in women with CPP, 2) a novel muscle network analysis technique to reveal the aberrant interaction 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 quantitative and real-time self-monitoring of both PFM activation capacity and inter-muscle interactions between the PFM and Hip/Trunk muscles to enable adaptive PFMT at home. This Phase I project will introduce a prototype of the CPP HomeTrainer device suitable for commercialization after 510(k) clearance. The proposed CPP HomeTrainer offers biofeedback to aid myofascial physical therapy and movement pattern training by tailoring the protocol to specifically break aberrant interactions between the PFM and problematic Hip/Trunk muscles.

Technology keywords

Not reported

Other awards by this recipient

Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.

Awards with the same topic code

Verified by an exact topic code match. This is not a text-similarity match.

Research funding history

3 SBIR/STTR records share this UEI (2021–2024). Reported award amounts total $1,061,819. Reported amounts are not federal obligations.

Phases: Phase I, Phase II

Agencies: Department of Health and Human Services

Agency intelligence

Department of Health and Human Services

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