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Investigators

“The Science of pain is complex and its assessment subjective, leading to bias and health inequality. Now, researchers are searching for a reliable, objective measure of pain.”

(How an objective measure of pain could counter bias in medicine; BBC The Health Gap)

Overview

PainTrace® Objectively Quantifies Pain for Accurate Evaluation of the Efficacy of Treatment

PainTrace® Multi-species Neurobiosignal is an Actionable Outcome Measure That Objectively Quantifies Acute and Chronic Pain In Many Use Cases Such As:

  • Treatment Efficacy​
  • Orthopedic Exam​
  • Perioperative Assessment​
  • Nociceptive, Neuropathic, Somatic, Visceral, Trigeminal

PainTrace® Multi-species Neurobiosignal is an Actionable Outcome Measure That Objectively Quantifies Acute and Chronic Pain In Many Use Cases Such As:

  • Treatment Efficacy​
  • Orthopedic Exam​
  • Perioperative Assessment​
  • Nociceptive, Neuropathic, Somatic, Visceral, Trigeminal
  • PainTrace is an objective neurobiosignature correlated with human self-reported pain

  • PainTrace differentiates acute and chronic pain, measuring both magnitude and duration of the pain experience

  • Quantify the individual experience of pain with an objective outcome measure to strengthen research conclusions

  • The PainTrace Baseline measures chronic pain. Positive values indicate degree of non-painful state and increasing negative values indicate mild, moderate, and severe chronic pain state.
  • PainTrace Acute Peaks quantify response to orthopedic examination, activity, palpation. Peak amplitudes are highlighted by intensity​.​

            YELLOW = MILD

            ORANGE = MODERATE

            RED = SEVERE

PainTrace Pain Scale
  • The PainTrace Baseline measures chronic pain. Positive values indicate degree of non-painful state and increasing negative values indicate mild, moderate, and severe chronic pain state.​
  • PainTrace Acute Peaks quantify response to orthopedic examination, activity, palpation. Peak amplitudes are highlighted by intensity​.​

            YELLOW = MILD​

            ORANGE = MODERATE​

            RED = SEVERE

PainTrace Pain Scale

Case Examples

Shoulder arthritis: chronic pain and locates acute pain

Moderate chronic pain, right shoulder: severe acute pain, and left shoulder: mild acute pain Xray: bilateral shoulder arthritis, small shoulder joint issues, biceps tendonitis.
Shoulder arthritis

Osteoarthritis: Pre- and Post-NSAIDs

Screenshot 2023-05-04 at 1.52.48 PM
NSAIDs

Chronic Pain with NSAIDs for 18 Weeks

Chronic Pain NSAIDs

Effect on PainTrace® Baseline values, indicating chronic pain state, with the administration of NSAIDs over 18 weeks

  • NSAID’s were administered over 18 weeks. PainTrace Baseline was monitored to evaluate treatment efficacy to mitigate chronic pain
  • NSAID administration initiated March 7
  • PainTrace Baseline Average denoted chronic pain (-6.43) prior to NSAID therapy; March 4 – 6
  • Improvement to a pain-free PainTrace Baseline Average (+3.23) while administering NSAID; April 1 – July 21
  • Measure of efficacy using Treatment Delta = 9.66
  • After stopping NSAIDs chronic pain returned; PainTrace equals -1.3- on November 3

Effect on PainTrace® Baseline values, indicating chronic pain state, with the administration of NSAIDs over 18 weeks

  • NSAID’s were administered over 18 weeks. PainTrace Baseline was monitored to evaluate treatment efficacy to mitigate chronic pain
  • NSAID administration initiated March 7
  • PainTrace Baseline Average denoted chronic pain (-6.43) prior to NSAID therapy; March 4 – 6
  • Improvement to a pain-free PainTrace Baseline Average (+3.23) while administering NSAID; April 1 – July 21
  • Measure of efficacy using Treatment Delta = 9.66
  • After stopping NSAIDs chronic pain returned; PainTrace equals -1.3- on November 3
Chronic Pain NSAIDs
Chronic Pain NSAID

 

 

“To better understand chronic pain, we first need to address the problem of how to evaluate the severity of pain.”

(Objective Pain Assessment: a Key for the Management of Chronic Pain. F1000 Research)

 

 

Challenges

90% of Pain Studies Fail

  • “The overall probability of successful development of all pain medications from phase 1 to approval is 10.4%.” and success in the development of new therapeutics with low abuse potential is even lower at 4.7%.

(Estimates of Probabilities of Successful Development of Pain Medications: An Analysis of Pharmaceutical Clinical Development Programs from 2000 to 2020; Anesthesiology)

Costly Studies to Perform

  • Pain studies cost 1.6 times more than other studies.

  • Pain and anesthesia trials rank in the 3 most expensive by therapeutic area for phase 2, 3 and 4.

(Examination of Clinical Trial Costs and Barriers for Drug Development; US Department of Health and Human Services)

Clinical Study Cost by Phase and Therapeutic Area

Impact

1. Quantitative Measure •Support animal welfare with a pain neurobiosignature for non-verbal patients •Objective acute and chronic pain measurement using proprietary electrodermal sensors 2. Stratification •Normalize populations specific to existing pain in each subgroup, reducing selection bias •Individual bio signal to uniquely represent each study participant 3. Inter-Species Translation •Multi-species neurobiosignal to facilitate translation of animal models between species •Objective measurement of subclinical and clinical pain in multiple species 4. Ethical Inclusion and Diversity •Mandated diversity and inclusion by research funding agencies •Individual biosignal to address the importance of ethical diversity and precision 5. Efficiency •80% power achieved with cohorts under 15 based on current studies •Objective individual pain measurement from stratification through outcomes

Process

PainTrace® Partnership Program

Working to help you achieve your goals every step of the way

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Contact

Contact us to find out how PainTrace® impacts your research goals.

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Contact us to find out how PainTrace® impacts your research goals. 

We're here to help.

References

  1. Naomi Elster.  How an objective measure of pain could counter bias in medicine.  https://www.bbc.com/future/article/20230414-the-search-for-an-objective-measure-of-pain. BBC The Health Gap; 16 April 2023.

  2. Dermot P. Maher, MD, MS, MHS, Chi Heem Wong, PhD., Kien Wei Siah, PhD., and Andrew W. Lo, PhD.  Estimates of Probabilities of Successful Development of Pain Medications: An Analysis of Pharmaceutical Clinical Development Programs from 2000 to 2020; Anesthesiology 2022; 137:243-51.

  3. Aylin Sertkaya, Anna Brikenback, Ayesha Berlind, and John Eyraud. Examination of Clinical Trial Costs and Barriers for Drug Development; Report submitted to U.S. Department of Health and Human Services; 2014.

  4. Xiaohan Xu et al.  Objective Pain Assessment: a Key for the Management of Chronic Pain. F1000 Research; 2020; 9: F1000 Faculty Rev-35.

  5. Anke Samulowitz, Ida Gremyr, Erik Eriksson and Gunnel Hensing.  “Brave Men” and “Emotional Women”: A Theory-Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain.  Pain Research and Management: Volume 2018 Article ID 6358624.

  6. Carmen R. Green, MD, Karen O. Anderson, PhD, Tamara A. Baker, PhD, Lisa C. Campbell, PhD, Sheila Decker, PhD, Roger B. Fillingim, PhD, Donna A. Kaloukalani, MD, MPH, Kathyrn E. Lasch, PhD, Cynthia Myers, PhD, Raymond C. Tait, PhD, Knox H. Todd, MD, MPH, and April H. Vallerand, PhD, RN.  The Unequal Burden of Pain: Confronting Racial and Ethnic Disparities in Pain.  Pain Medicine; 2003: Vol 4 , No 3:277-294.

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