PRESSURE PROFILE SYSTEMS, INC. — Department of Health and Human Services SBIR Phase II: NIBIB

Description

ABSTRACTCarpal tunnel syndromeCTSis one of the most widely recognized occupational health conditionsDomesticallythe condition affectsof adultsAccording to areport from the Bureau of Labor StatisticsCTS is associated with the second longest average time away from workdaysof all major disabling diseases and illnesses in all private industriesThe cumulative economic cost is in excess of $billion annuallymaking this the most expensive peripheral neuropathy in the United StatesCurrentlycarpal tunnel releaseCTRsurgery is indicated in almost all patients with moderate to severe CTSCTR surgery involves division of the transverse carpal ligamentTCLThis surgery reduces pressure on the median nerve by increasing the volume of the carpal tunnelUnfortunatelysurgery is invasive and has a large incidence of symptom recurrence and morbidityUp toof CTR surgery patients report poor to fair strength and long term discomfortandhave recurrence of some pre operative symptoms beginning an average of two years after surgeryIn recent yearsbrace like ligament tensioning devices that attempt to emulate the effects of surgery have emergedbut these devices have had limited success due to the uncomfortable high forces required to manipulate ligament tissues and the lack of compliance due to their obtrusive designA novel approach to providing long duration tensioning to carpal tunnel ligaments without reliance on excessive force and or cumbersome design would be highly desirable as an alternative to CTR surgeryThis Phase II SBIR project will continue development of a Carpal Tunnel Tissue Manipulation DeviceCTMDthat uses negative pressure to relieve compression on the median nerve without excessive force or cumbersome designsUnlike the majority of traditional and dynamic splintsthe proposed device allows for free movement of the wrist with minimal impediment during daily activitiesOur self funded Phase I efforts involved multiple design iterations until a working prototype was ready for a clinical trialWe then evaluatedweeks of CTMD treatment inpatients with mild to severe CTSThe study showed that the CTMD reduced CTS symptoms at the end of treatmentweeksand improvement continued or was maintainedmonths after treatmentas determined by the Boston Carpal Tunnel QuestionnaireBCTQSymptom Severity ScaleSSSIn this projectthe CTMD prototype will be refined to fit more people and will be validated in a largerlonger clinical trialIn AimPPS will finely tune the design specifications of the CTMD to fit more patients with input from magnetic resonance imagingMRIand pressure profile measurements in humans and cadaversIn Aimthe new design will be investigated in asubjectmulti sitesingle blindedrandomized controlled trial that compares the CTMD to a placebo controlUltimatelythis device could provide a noninvasivesimple and easy to uselow cost alternative to surgery for the millions that suffer from CTS PROJECT NARRATIVE Carpal tunnel syndromeCTSis one of the most widely recognized occupational health conditionsit affectspercent of adults in the United StatesThis project involves refinement of the Carpal Tunnel Tissue Manipulation DeviceCTMDfollowed by a multi siteplacebo controlled clinical trial to validate its effectivenessThe CTMD is novel because it relieves pressure on the median nerve without reliance on surgery or a cumbersome splint designThe CTMD could be a simpleeasy touseand non invasive treatment of CTSwhich could result in long lasting symptom relief to patients and reduced cost to employers and the health care system