Patent Application
20220240844
None
None
The invention relates to the general field of rehabilitation potential in painful musculoskeletal and neuropathic conditions. Specifically, the invention relates to maximizing multidimensional protocols for the rehabilitation and pain resolution in patients with chronic painful musculoskeletal and neuropathic conditions.
The resolution of chronic pain syndromes is a major problem in our society, especially in the current time of the Opioid Crisis. It is estimated that 85% of the Opioid Crisis does not involve what are generally perceived to be “street addicts.” Rather, about 85% of the individuals suffering from opioid addiction in the United States are actually ordinary people who had surgery for such conditions as back surgery, hip surgery, knee surgery, etc. After surgery, they may be initially put on morphine for a few weeks and then put on oxycodone for about two months. Thereafter, they were put on hydrocodone for a period of time.
By the time they are healed, they may become addicted to opioids and when they are taken off opioids, their mind brings back the pain root and they are suffering without the opioids, which they crave due to their addiction. When put back on the opioids, after some period time, the amounts of opioids they were prescribed are not enough and they may be prescribed larger doses of opioids. A significant number end up going from doctor to doctor to obtain more opioids to relieve their chronic pain, which has resulted in a terrible Opioid Crisis in the United States.
It is now well-established that the best approach to manage patient pain is the use of a multidimensional pain rehabilitation program according to the Biopsychosocial Model of Pain (BPSM). The problem of chronic musculoskeletal pain treatment has been extensively analyzed. A 2010 review of the world's literature by the International Association for the Study of Pain found that a multidimensional pain treatment program provides a safer and far more effective approach for the functional rehabilitation of patients than the current biomedical approach of surgeries, anesthetist injections and opioid medications (IASP Fact Sheet No. 7: Evidence-Based Biopsychosocial Treatment of Chronic Musculoskeletal Pain 2010).
Currently, there are both inpatient and outpatient programs. The problem is that many of the best programs are very expensive. The best published results indicate that the pain relief achieved is in the range of 60 to 65%, which is grossly insufficient. As a result, much improvement is needed.
The Biopsychosocial Model of Pain is based on the International Association for the Study of Pain (IASP) definition of “pain” as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.” This definition explicitly implies that the pain experience has three components including: [a] sensory-physical aspect; [b] an emotional element; and [c] a learned socio-dynamic constituent. Applicant's prior invention “Evaluation of Pain in Humans” U.S. Pat. No. 10,292,640 B2 was the first neurophysiologic assessment of these constituents and their respective interaction.
There is currently no method to refine the Biopsychosocial Model to the area of pain rehabilitation. There are many variations on the rehabilitation techniques including inpatient and outpatient paradigms. A systematic literature review of the world's data on multidimensional pain rehabilitation programs and their published outcomes analyzed 41 separate programs with different but fairly fixed programs, i.e., the same approach for all admitted patients. The published review is available at “Kamper S J, Apeldorn A A T, Chiarotto A T, et al. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane Systematic Review and Meta-analysis. BMJ 2015: 350: h444.”
Current programs report similar outcomes demonstrating that no single method is overall superior. The inference is that “no glove fits all.” The critical problem is therefore to better identify the specific needs of each particular patient. There are many obstacles to rehabilitation falling into motivational, physical, and emotional categories. Some of the physical ones include incorrect diagnoses, refractory pain, deconditioning, and others. Some of the emotional ones include fear avoidance, catastrophizing, generalized anxiety, depression, childhood adverse events, emotional awareness deficits, and others. There are motivational obstacles including factitious disorder, personality disorders, malingering, apathy and others.
Currently, the only mechanism used to distinguish between these mechanisms involve physician/psychologist judgment by interview and questionnaires. These methods are subject to bias and the limitations of self-report. Identifying physiologic biomarkers that better categorize these elements will improve accuracy to the rehabilitation protocols and allow individualized precision medicine intervention. This would be a first of its kind invention because no physiological biomarkers exist for these mostly “psychological concepts.”
Although there are patents in the general field of this patent application, none of the above-listed patents and publications, alone or in any combination, teach or suggest the claimed invention.
There exists a great need in our country to overcome the current problems associated with individuals becoming addicted to opioids.
The present invention provides a means of better identifying the needs of the individual patient, based on unequivocal neurophysiologic biomarkers. This allows implementation of more precise rehabilitation programs with greatly improved outcomes.
The cornerstone of functional physical rehabilitation for painful musculoskeletal and neuropathic condition is motion. There are three basic types of movement of a given body region. The three basic types of movement are isotonic, isometric, and isokinetic motions. Isokinetic movements are fairly uncommon in nature, and will not be further described herein. Isotonic movement, as a term, describes movement against a relative constant resistance. Isometric movement describes attempted movement against an immobile obstacle. Negative emotional and sociological factors can interfere with these movements, in different ways. This is the part of the mechanisms by which these movements maintain and exacerbate the pain experience. Additionally, these are the mechanisms by which they interfere with functional pain-related rehabilitation.
Based on neurophysiologic brain principles, the method by which these negative bio-psychosocial mechanisms manifest themselves have different neurophysiologic profiles. The invention for the first time exploits these patterns to classify and identify which mechanisms are operative in a particular individual.
The invention employs four outputs to monitor brain and central nervous system output; these include blood volume pulse, heart rate, skin conductance response for autonomic measurements; and surface electromyography for somatic measurements. These outputs will be monitored before, during, and after the stimulations.
The invention employs two types of inputs; i.e., for isotonic and for isometric movement, at two different levels of intensity. It also compares response under these either, as warranted, inputs in a control region of the body to the same inputs to the responses to the test, i.e., painful body region. Thus, each person acts as his or her own control, mitigating such issues as age, gender, race, concomitant medical conditions, and culture. Each protocol will be performed three times at two different intensity starting with the control site. The first intensity will be the Odynic Identification Threshold (OIT), which is defined as the stimulus intensity when the individual first states that tenderness or discomfort is felt during the motion. The second intensity will be the Odynic Tolerance Level (OTL) which is the maximum movement or exertion the individual is willing to sustain for three seconds. Based on physiologic principles, a maximum discomfort, whether sensory-physical or emotional, should be associated with a robust increase in autonomic phenomena.
with regard to comparing profiles, by comparing data and graphs between control site conditions, the healthcare provider can assess the presence or absence of generalized emotional-social factors of a generalized type that can impede rehabilitation. By comparing data and graphs between control and test site response, one can identify test-site problems that can impede rehabilitation. The types of changes indicated in
These examples show four of the five fundamental response types. These include: [a] the sensory physical type; [b] the reactive emotional response; [c] the anticipatory emotional response [not shown]; [d] the anticipatory and emotional response; and [e] the socio-dynamic response. These can mix in various combinations. The total number of permutations for the OIT stimulation is 15 (fifteen). Similarly; there are fifteen permutations for the OTL stimulation. Combining the two, there are 225 potential permutations for the combined OIT-OTL stimulations. It is this great heterogeneity that confounds current rehabilitation efforts. Providing healthcare professionals more accurate information about a particular patient's needs will vastly improve outcomes because of the greater assessment accuracy and detail.
Chronic musculoskeletal pain is a major health problem in most Western countries. In the United States, the direct costs of medical care is $150 billion annually. The total costs, including disability, lost productivity, and other costs, is estimated at $650 billion per annum. Despite these enormous efforts, musculoskeletal conditions are still the most common cause of work-age permanent disability. Attempts to control the pain have contributed to the prescription Opioid Crisis.
Modern science now proves that the most effective way of treating most cases of chronic musculoskeletal pain is with a multidimensional pain rehabilitation program; according to the Biopsychosocial Model of Pain. The term “Biopsychosocial Model or Pain” refers to the newer, scientifically validated multidisciplinary treatment of chronic pain with a team approach; physical rehabilitation, mental health care, and physician support. In general, the Biopsychosocial Model of Pain; in-patient multidisciplinary approach is far more successful than Biomedical treatments; with a minority of exceptions. BPSM approaches have success rates in the 60% range for return to work, versus 20% for the Biomedical approach. These programs include the combination of [a] medicinal oversight and medications; [b] physical rehabilitative approaches such as physical therapy, occupational therapy, and others; and [c] mental health intervention such as cognitive behavioral therapy, mindfulness, and others. There are many different ways of combining these various options. Because of this, there is no general consensus on how to best manage these musculoskeletal conditions; for example, chronic low back pain, in a particular individual. The physical rehabilitative efforts are often less successful than hoped because psychosocial factors such as depression, anxiety, fear of movement, or motivational problems interfere with adherence and outcomes.
Having a physiological biomarker that would address the physical rehabilitative and mental health needs of a specific individual would allow the patient to get a much more precise rehabilitation program tailored to that person's needs. The Physical Rehabilitation Physiologic Evaluation (PRPE) is uniquely designed to address that critical issue.
Currently, the choice of treatment is made by the healthcare professional's judgment and experience in combination with the patient's presentation. This is very prone to imprecision due to patient perception and expectations and provider bias-training. This imprecision explains why multidisciplinary programs often do not succeed (for return-to-work; the failure rate is above 35%).
The Neurophysiologic Range of Motion Test (NPRMT) and psychometric testing provide unprecedented clarity about the patient's rehabilitation needs and attitudes toward the rehabilitation process, which invariably requires improved movement and effort to restore musculoskeletal function. The following examples will provide illustrations of how therapy can be guided by results in patients with chronic low back pain. We will assume three simple patient types presenting with disabling pain.
Predominant Sensory Physical Profile Myofascial Tenderness. The NPRMT reveals substantively tender myofascial discomfort that increases with motion; there is no significant emotional component. The medications will be geared for control of inflammation and muscle spasms; trigger point injections can be used to reduce focal muscle spasms. This will be supplemented by physical therapy aimed at modalities and therapeutic exercises with a home exercise program for regional and generalized conditioning. The mental health interventions would be geared at progressive muscle relaxation and education.
Predominant Emotional Profile. The profile identifies little tissue tenderness but a patient with anxiety/depression increased dramatically by movement anticipation and reaction. The medications will be aimed at mild “pain control” with intermittent anti-inflammatory medications plus anxiolytic and depressive medications; i.e., pain adjuvants; trigger point injections will not be used. The physical therapy will be aimed at therapeutic and kinetic exercises of a progressive type supplemented by guided-increasing home exercises where modalities would not be emphasized. The mental health services would be comprised of mostly of mindfulness, progressive muscle relaxation, including motion-related cognitive behavioral therapy would likely be used.
Predominantly Sociodynamic Profile. The patient's profile reveals minimal tenderness and a suppressed emotional profile with decreased range of motion but no anticipation or reaction. Psychological interview reveals that the patient was a victim of abuse; e.g., child abuse or rape. The medications would be aimed at over-the-counter medications for pain; e.g., acetaminophen and pain adjuvants with antidepressants and anxiolytics as warranted. The physical rehabilitation would emphasize kinetic activities and alternative approaches, such as Yoga or Tai Chi. The mental health services would involve logotherapy and trauma psychology which is possible for any post-traumatic stress.
The reductionist biomedical approach to chronic pain which emphasizes MRI findings and nerve studies has been proven invalid. It does not adequately evaluate the complex nature of the human pain experience. Chronic pain syndromes (especially musculoskeletal or neuropathic ones) are extremely heterogeneous and nuanced. The current NPRMT invention provides the means to accurately differentiate many pain rehabilitative subtypes with a neurophysiological and scientifically valid analysis. That precision improves the rehabilitation algorithm and design that can now be designed with great clarity aimed at the particular patient's individualized needs and rehabilitation experience.
Although one or more exemplary embodiments have been shown or described, other exemplary embodiments would be readily apparent to those of ordinary skill in the art. As a result, the invention is not intended to be limited by the one or more exemplary embodiments, but rather by the metes and bounds of the appended claims.
