Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - SET - Chronic Pain (SET – The defibrillator for Chronic Pain)

Teaser

Chronic pain includes fibromyalgia, migraine/cluster headache, back pain, TMD, osteo- and rheumatoid arthritis, cancer pain, inflammatory muscle pain, and neuropathic pain. Chronic/persistent pain is a debilitating and disabling condition and can interrupt all aspects of a...

Summary

Chronic pain includes fibromyalgia, migraine/cluster headache, back pain, TMD, osteo- and rheumatoid arthritis, cancer pain, inflammatory muscle pain, and neuropathic pain. Chronic/persistent pain is a debilitating and disabling condition and can interrupt all aspects of a person\'s life, which can lead to physical deconditioning, psychological distress and social isolation. According to the WHO, one third of people with chronic pain suffer constant pain and are forced to live with it for an average of seven years. Over a fifth will endure pain for 20 years or more. The societal cost is over $300 billion. The comorbidities are hypertension, diabetes mellitus, sleep apnea, restless legs syndrome,chronic fatigue syndrome, rheumatoid arthritis, and breast cancer.

Today a doctor sees you for 5 minutes while you complain what hurts. He either gives you an opioid prescription or schedules you for back surgery based upon an x-ray, MRI, CT, or other imaging technology. This information is not sufficient to make a proper diagnosis as there is only a weak relationship between an impacted disk and pain. ICT data taking into consideration patient heterogeneity is the only way to attack this problem. Alternative medicine, eastern medicine, TENS, and other methods generally do not work at all, or if they work, they only work for a short period of time.

None of the above solutions look at data, biomarkers, or take into consideration the individual differences between patients. With real data from large groups of patients, Kleinklein can for the first time ever characterize the autonomic nervous system, which is depreciated in chronic pain patients, and use it to fight chronic pain. With the therapy, Kleinklein attacks the underlying psychological cause for the pain. The SET device (described below) allows us to do this efficiently. Using data, Kleinklein will be able to make real progress on this large social problem. By iterating, continuing to add data, measuring results, and adjusting and further personalizing approaches, Kleinklein can attack chronic pain and make people pain free.

SET is a novel, yet proven, treatment protocol and infrastructure that can make most chronic pain sufferers pain-free. SET uses individualized painful and pain-free electrical stimulations to the finger timed to coincide with the systolic and diastolic peaks in the cardiac cycle. The stimulation raises BRS, which is diminished in chronic pain patients. SET combines this stimulation with operant behavioral therapy to put in place healthy behaviors. During a 2-hour session, the SET device is attached to the patient for two 8-minute periods. The therapy practices healthy adaptive instead of pain behaviors. The operant approach is to learn by doing rather than directly attempting a cognitive change (CBT). The standard treatment requires 10 double sessions over 5 weeks (20 hours) with a behavioral therapist. A therapist and patient E-learning program defines the protocol, session by session, and tracks patient exercises.

The SET device ‘Impuls’ collects baroreceptor sensitivity (BRS), blood pressure, muscle tension, patient history, patient standardized questionnaires, and other patient data in a central cloud server. The optimum stimulation and therapy parameters can then be downloaded to a treatment device. This intelligent, learning, database supported pain treatment model will revolutionize chronic pain treatment by 1) individualizing each patient’s treatment protocol and 2) adjusting the treatment based upon patient progress.

The SET (Systolic Extinction Training) protocol, which this project seeks to develop, acquires and stores heart rate, blood pressure, baroreflex sensitivity (a chronic pain biomarker) and actively makes patients pain free. A recent University of Marburg RCT study with 65 patients showed a significant decrease in pain severity (MPI) after SET in comparison to control groups (p>0.001), an increase of BRS, an increase of heart rate variability (HRV), and changes in the high frequency component of HRV corresponding to parasympathetic tone (HF; Thieme et al., 2014). Furthermore, the sympathetic outflow measured by microneurography was significantly reduced (Lautenschlaeger et al., 2014) after SET.

By rolling out the SET device and treatment to outpatient psychological and physical therapists, Kleinklein, GmbH intends to develop the largest detailed database of chronic pain patients with their physical data in the world. Furthermore, pain patients, the intimal focus of the device, will become pain-free. Data analysis will identify the patient\'s response to SET and other therapies, based upon their physiological profiles. Over 100 million chronic pain patients are actively looking for solutions to solve their pain.

This study describes the market and explores the feasibility of putting SET devices along with the requisite training into therapist’s hands. The device and associated E-learning training program collect individual chronic pain patient’s psychophysiological parameters over a large number and wide variety of patients. The data of what worked for whom is processed and in turn varies the stimulation and other treatment parameters. The process gets better and better and meanwhile the attractiveness, individualization, and differentiation of SET improves, creating both a feed forward and a network effect.

Work performed

The feasibility study was completed for the Phase I grant. Kleinklein\'s business plan was refined, operations plans, financial projections, market validation with go to market strategy as well resources and the work plans for the to be submitted Phase II grant application. The project was found to be even more viable and advantageous than was anticipated with strong demand both from patients and therapist with a very doable implmentation strategy.

Final results

Chronic pain can be solved for a substantial percentage of sufferers.

This feasibility study demonstrates that the SET - Chronic Pain project is both feasible and will create many new jobs in Europe through new clinics as well as make chronic pain patients pain free. The approach is to enable both physical and psychological therapists to adopt the SET therapy. In the process, these therapists, with help from the SET device, the E-learning program, and the patient’s personal cell phones, will collect broad multifaceted physical, psychological and lifestyle data on chronic pain patients. This data will permit incremental improvement in the definition or chronic pain subgroups and their tailored treatments. The large but focused database, data mining, and artificial intelligence tools will support and enhance this process. The approach is openly disruptive and will revolutionize the way chronic pain is treated.

Fundamentally, the elimination of chronic pain requires behavioral change. This requires patients to take responsibility. Our therapists, through SET, become experts at helping their patients to do this and are able to adapt their technique with respect to individual differences. Large detailed datasets and training make this possible. The University of Marburg has proven that it works.