Problem in Clinical Research

Current Methodology

To gauge a patient’s pain state, clinical researchers use the visual analog system (VAS) which is a scale between 0-10 (0: no pain & 10: worst pain imaginable). Patient’s are ASKED to report their pain levels between 0-10 pre and post intervention; if a reduction is shown relative to placebo than the drug is considered efficacious.

Problems with Current Methodology:

Patients are terrible at providing a good estimate of their internal state and have no good basis for differentiating between pain states especially in the middle of the scale: 3-7.

Problems with Current Methodology Lead to:
  • High failure rate of pain drugs due to heterogeneous/internal variability patient pain reporting
  • Increased cost of clinical trials caused by the necessity smooth out variability in patient pain reporting by having large patient sample sized
  • Lack of investor interest due to erratic measurement of end point
Current Standard of Care: Visual Analog Scale (VAS)
  • Not Verifiable

  • Not Replicable

  • Subjective

Solution in Clinical Research

PainQx solves the logic chain below by providing: Objective Pain Measurement: Reduces clinical trial costs and risks

Scaled Pain and Neurological Side-effect Biomarkers: Improves data, research outcomes; validates research products

Patients’ brain waves are analyzed pre and post intervention. PainQx generates a PQ score for each patient between 0 – 10. If a reduction is shown relative to placebo than the drug is considered efficacious.

Advantages of PainQx Methodology:

The PQ score is a quantifiable and objective measurement that can be used to use to evaluate the efficacy of analgesic drug:

  • Removes the need of a patient to verbalize their pain state.
  • Removes sociological influences on the patient as clinician does not have to verbally administer the test.
  • Requires no esoteric equipment and can be easily implemented in IRB.
Advantages of PainQx System Lead to:
  • Reduces failure rate of pain drugs by providing objective, homogenous patient pain reporting.
  • Clinical trial costs are significantly curtailed due to reduced sample sizes needed since patient reporting variability has been decreased.
  • Increased investor interest as end points become less erratic, increasing the likelihood of FDA approval.

Problem in Chronic Pain Clinics

Current Methodology

To gauge a patient’s pain state physicians rely on a set of survey questions which are answered by the patient. The most common being the visual analog scale (VAS).  The VAS requires patients to evaluate their own pain levels and communicate that reading on a scale from 0-10 (0= no pain: 10= worst pain imaginable).

Once a baseline is determined the physician makes a treatment recommendation taking into the account the patient’s reported pain state and medical history. Follow-up visits are required to see if treatment has led to a reduction of a patient’s pain state from baseline.

Problems with Current Methodology:

Patients have difficulties providing a good estimate of their internal state.  This problem is compounded by the fact that patients have no good basis for differentiating pain scores, especially in the middle of the scale (3-6; 6-8); they can only compare to memories or imagined pain.  Patients’ pain scores, and their verbal behavior changes when patients interact with people in medical authority, skewing the data.

Problems with Current Methodology Lead to:

Lack of a reliable baseline from visit to visit creates uncertainty if a treatment is working leading to massive costs in the health care system due to poor patient outcomes.

  • Overdosing of patients can lead to addiction to particularly of opioids
  • Underdosing of patients leads to unnecessary pain for the patient
  • Lack of reliable of objective patient pain state increases the liability to doctors as disputes are focused on patient reported results
Current Standard of Care: Visual Analog Scale (VAS)
  • Not Verifiable

  • Not Replicable

  • Subjective

Solution in Chronic Pain Clinics

The PainQx platform system is currently an investigation medical device. The PainQx platform will be seeking FDA Clearance as a Class II medical device in 2020.

The PainQx platform upon FDA Clearance will solve the logic chain below by providing:
  • Objective Pain Measurement: Improves patient outcomes
  • Patient Pain State Confirmation: Empowers practitioner’s clinical decisions
  • Effective Pain Management: Eliminates under / over treatment dilemma

Measuring A Patient’s Pain State With PainQx:

Patients’ brain waves are analyzed and PainQx generates a PQ score for the patient between 0 – 10 providing an objective baseline. Once a baseline has been established the physician continues with his/her traditional measurement strategies. Once completed the physician makes a treatment recommendation based on the patient the PQ score, medical history, and self-reported measures.

Advantages of PainQx Methodology:

The PQ score is a quantifiable and objective measurement tool that the doctor can use to establish an initial patient pain state at baseline and subsequent visits.

  • Removes the need for a patient to verbalize their pain state
  • Removes sociological influences on patient as clinician does not have to verbally administer test
  • Provides a third party measurement reducing variability of a patient’s pain state
Advantages of the PainQx Platform May Lead to:
  • A reliable baseline from visit to visit creates reduces uncertainty of treatment outcomes leading improved clinical outcomes and savings to the healthcare system
  • Improved dosing leads to fewer incidence of opioid abuse thereby reducing the risk addiction
  • Improved dosing leads to a reduction of cases of underdosing improving patient satisfaction
  • The presence of a quantifiable and objective tool that measures a patient’s pain state reduces a physicians liability during disputes as independent third party can be included in the discussion