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10 Articles in Volume 17, Issue #10
A Guest Editorial on Counterfeit Pain Medication: The Other Epidemic
A Model to Incorporate Functional Medicine into Chronic Pain Care
Chronic Pain and Substance-Related Disorders
Getting at the Root of Opioid-Induced Constipation (OIC) with an Osteopathic Approach
Inside FDA's Guidance on Generic Abuse-Deterrent Opioids
Neural Pathway Pain — A Call for More Accurate Diagnoses
Pain Care in a Natural Disaster
Pharmacological Interventions in Sport-Related Concussion
The Internet of Medical Things
What Type of Withdrawal Symptoms from Tramadol Might a Patient Experience?

A Model to Incorporate Functional Medicine into Chronic Pain Care

A pilot study assesses the benefit of patient participation in a functional medicine program to decrease idiopathic chronic pain and related symptoms among a group of veterans.

According to the Centers for Disease Control and Prevention,1 chronic diseases and conditions including arthritis, cancer, chronic pain, dementia, depression, diabetes, and posttraumatic conditions, are among the most common, costly, and preventable of all health problems. More concerning, the combined incidence of heart disease, diabetes, and cancer is lower than that of chronic pain.1 In addition, specific health risk behaviors, such as being sedentary, poor diet, tobacco use, inadequate sleep, and excess alcohol consumption, contribute to illness, suffering, and early death associated with chronic diseases and conditions.1

It is very common for Americans to numb themselves with low-quality foods, reality TV, and a variety of socially acceptable addictions, which may be ascribed to the idea that “ignorance is bliss.” Yet, each human has a unique genetic code that is guided by and responsive to the surrounding environment. Almost daily, two factors—genetics and the environment—have an infinite number of combinations with a potential to support health or yield to disease.

The authors initiated a pilot study to assess the efficacy of a functional medicine model of care to reduce pain and other symptom complaints in a group of veterans. In order to fully appreciate the methodology behind the study, a full explanation of the functional medicine model is needed.

Functional Medicine Encompasses Individual Biopsychosocial Needs

Functional medicine is a comprehensive, integrated approach to care that aims to address the underlying causes of disease, using a systems-oriented approach and engaging both patient and practitioner in a therapeutic partnership.2

The functional medicine approach looks to optimize the health of the body’s cells, and to offer support to the biopsychosocial functions that support healthy aging. When the cells meet with negative environmental assaults, the result is usually poorer outcomes. Conversely, when the body is provided with a personalized best in environmental options, the person has the greatest chance for good health. It is a dramatic departure from the standard Western methodology, which may be described, by some, as assembly-line medicine. The heavy focus on technology (ie, imaging, blood labs, EKG) has led to less touch, and a focus on basic proficiency without any emotional engagement. Modern medical care has evolved to offer better care for acute ailments, but less so for chronic conditions. In effect, the practice of clinical care would be best served by evolving to one of—why, not what—which is the fundamental goal of functional medicine.

Taking Time for a Thorough Patient Assessment

The role of functional medicine practitioners is to dedicate the time needed with patients. It is essential to listen to patient histories and to look for  possible interactions between genetic, environmental, and lifestyle factors that may influence long-term health, aging, and the development of chronic diseases, including chronic pain.

As part of assessing the patient’s current status, the provider may assess the person’s social environment in order to help them recognize that they only have control over their own lives. The focus is then changed from patients trying to get something from their loved ones to a perspective of the patient nurturing what is desirable from social connections. 

While love is integral to every person’s life, it is not something that can be measured or tested because each person experiences it differently. Yet, it is easily felt when it is present. Another way to consider this is to view love as if a concert of all the chemical reactions in the body, including hormones and neurotransmitters. If the practitioner prepares these instruments to perform at their best, than it is anticipated that love may have its best expression, and manifest as health.

Forming an Intimate Impression of the Patient

To gain a full understanding of a patient’s cellular needs, a thorough history and exam may include gathering information from the patient in the form of antecedents, triggers, and mediators:3

  • Antecedents are the predecessors to our health, such as our unique genetic code  
  • Triggers are those activating events that can lead to dysfunction, such as exposure to environmental toxins
  • Mediators are those issues that may perpetuate dysfunction, such as a poor diet or lack of sleep.

The functional medicine provider typically plots the accumulation of information on a timeline (see Figure 1, page 29), as a means of determining where the greatest area(s) of cellular dysfunction may originate and to act as a guide to care.  

Seeking the Underlying Cause of Chronic Pain

Rather than seeking to alleviate a symptom, the practice of functional medicine aims to identify the root cause of the disrupting symptoms. A functional medicine provider is trained to recognize an underlying clinical imbalance and then seek the best approach to restore balance or a health equilibrium.3  

The functional medicine specialist usually relies on the health matrix, which compiles information from each of the seven nodes (see Figure 2), which work in unison, rather than individually. The interconnectedness of the nodes aims to reinforce the impact that each will have on the others, which will ultimately reflect as health or dysfunction, which may manifest as pain and disease.

To find the initiating cause(s) of dysfunction, the functional medicine provider will utilize the seven nodes of the matrix to target the origin of the greatest clinical imbalances.3 The nodes of health include: assimilation, defense and repair, energy, biotransformation and elimination, transport, communication, and structural integrity, as denoted in Figure 2.  

Nutrient Assimilation and Gut Health

A common functional medicine concept, “heal the gut,” is used to describe not only the need for a fit GI tract but also calls attention to the influence the gut has in supporting the integrity of the entire physiological system well beyond the digestive tract.

Assimilation, for example, is the process of digestion and absorption of nutrients into the gastrointestinal (GI) tract and then transported throughout the body. Nutrients are also assimilated through the respiratory tract. To recognize dysfunction in the GI tract, a provider will need to assess the process of digestion and absorption, intestinal permeability, presence of a healthy gut microbiota, immune modulation, and the connection of the gut to the nervous system.  

A dysfunction at any point along the GI tract may introduce or lead to systemic inflammation, which, if addressed, may help in the healing process; if unattended, it may foster undesirable, adverse consequences.

Immune System Integrity

Defense and repair is a node of health that is achieved by a properly functioning immune system and the ability of the body to regulate the inflammatory processes. Inflammation may help the body to heal, but it also has the potential to promote illness and disease when it persists or gets out of control, causing damage and pain.Thus, functional medicine providers assess the patient’s practices and behaviors that may identify the cause(s) of immune dysfunction, such as a proinflammatory diet, food allergies and intolerances, microbial infections, hormonal imbalances, or nutritional deficiencies. Imbalances to any of these areas may lead to dysregulation of the inflammatory system.

Cellular Energy Production

Energy focuses on the need for and production of energy within the cells throughout the body. A strong focus of this node gives attention to the mitochondria, or the powerhouse of cells. Dysfunction in energy production may arise from various causes, such as exposure to toxic chemicals or a nutritional deficiency.

A breakdown in energy production may be sensed by the patient in any part of the body that contains mitochondria, but may be most noticed in areas of highest mitochondrial concentration, such as the brain and heart. Dysfunctions in the cells in these organs might manifest with symptoms such as chronic pain, headache, dementia, anxiety, and depression.

Biotransformation, Elimination and Detoxification

Biotransformation and elimination describes the node of the matrix encompassing toxicity and detoxification. The human body is designed to eliminate toxins but at varying rates. If the toxic burden is too great, dysfunctions arise, usually in the form of pain. Toxicity may exist as a single entity, such as a heavy metal, but more often occurs in multiple units affecting the total body. When this total body burden is present, the functional medicine provider may guide the patient through a process of detoxification.

Cardiovascular and Lymphatic Systems

Transport is the node of the matrix representing the cardiovascular and lymphatic systems. Freedom of flow through these two systems allows for blood and lymphatic functioning.

A dysfunction in one of these systems may lead to cardiac issues, such as heart failure and hypertension, or lymphatic issues, such as lymphedema.

System Communication

Communication occurs through the endocrine and immune systems, or more specifically, through the conduction of neurotransmitters. A functional medicine provider will assess the integrity of these lines of communication to uncover any physiological disruptions. Since every cell relies on communication in order to fulfill its purpose, a breakdown in the lines of communication may manifest as fibromyalgia, hypothyroidism, polycystic ovarian syndrome, diabetes, or chronic pain, for example.

Musculoskeletal Integrity

Structural integrity is a node of the matrix referring to the subcellular membranes and musculoskeletal structure of the body. Dysfunction affecting any of these cell groups will cause physiologic impairments, such as increased intestinal permeability, cardiomyopathy, reflux, osteopenia, and similarly driven, structural abnormalities. Information from the history will be used to determine whether any of these structural abnormalities may be present. The information gathered from the patient history and physical exam identify imbalances and establishes which nodes require the focus of treatment.

To gain further understanding of any dysfunction, the FM provider may wish to use specialized laboratory tests for genetics, stool, exposure to environmental toxins, advanced lipid analysis, and markers of inflammation as a guide.

Pilot Study of Functional Medicine Approach

According to the American College of Preventative Medicine, most chronic diseases are preventable and reversible if a comprehensive, individualized approach that addresses genetics, diet, stress, physical activity, sleep, and relationships is implemented through integrated FM teams and based on empirical research.4

Through clinical practice, the authors found that the most effective and efficient way to address most causes of dysfunction has been through diet. Many clinicians have been told that diet effects health, but that was not backed up with enough training to appreciate the direct impact that dietary choices may have on the biopsychosocial milieu that drives health. The old standard–calories in and calories out model of teaching supported by a focus on daily allowances of nutrients—is the teaching of yesterday. Rather, clinicians are encouraged to recognize that every bite taken is either fighting disease or fueling it.

The single best avenue to promote health is the ability to guide each patient through a personal experiment (otherwise known as an elimination diet) to determine which foods offer the best support for optimal function, avoidance of disease, and reversal of pain.

The purpose of this pilot study was to evaluate whether participation in a functional medicine model of care would significantly decrease pain intensity, weight, waist/hip circumference, medical symptoms/toxicity, perceived stress, insomnia, and improve walking speed.

Study Methods

A sample of 51 veterans ranging in age from 18 to 75 years old with mixed, idiopathic, chronic pain conditions were recruited for this trial at Jesse Brown VA Medical Center. The one-year intervention was implemented from May 4, 2016 to April 26, 2017. A group format was used with individual follow-up sessions, as needed. The group treatment protocol consisted of four sessions, lasting approximately 60-75 minutes in duration.

The interdisciplinary treatment team consisted of an osteopath physician, a health psychologist, and a dietitian. Patients were coached to change their environment and create an anti-
inflammatory lifestyle by addressing four key pillars: diet, exercise, stress management, and sleep hygiene. For a more detailed description of the intervention, refer to the previous formative article by the authors.5

Focus on Elimination Diet

A modified elimination, anti-inflammatory diet (see Table 1) was held as a key aspect of the intervention.6,7 The elimination diet was usually introduced in three phases with adjustments made to meet specific patient needs (ie, vegetarian, diabetes, Celiac disease). Additional foods may be eliminated (eg, eggs, soy, peanuts) as needed once the patient has successfully complied with the initial three levels of the diet.

View a PDF of Table 1

Outcome Measures: During the first and last session, all participants completed an intervention assessment (pre- and post-) that included the Medical Symptoms Questionnaire (MSQ),8 the Perceived Stress Scale (PSS),9 and the Insomnia Severity Index (ISI).10

The Medical Symptoms Questionnaire was used to identify underlying causes of illness and helped to track patients’ progress. The health profile of veterans was divided into 15 subsystems, including head, eyes, ears, nose, mouth, skin, heart, lungs, digestive tract, joints/muscle, weight, energy, mind, emotions, and other. Participants were asked to rate symptoms based on their health profile for the past 30 days. After the last session, participants were asked to record symptoms based on the past 48 hours

Scores ranged from less than 10 (optimal), 10-50 (mild), 50-100 (moderate), and over 100 (severe toxicity). The Institute of Functional Medicine recommends that practitioners access the questionnaire through their website. [http://www.functionalmedicinemaine.com/wp-content/uploads/Medical-Symptoms-Questionnaire.pdf]

The Perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in the patient’s life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents rated their lives. The scale also included a number of direct queries about feelings, thoughts, and current levels of experienced stress during the last month. PSS scores were obtained by reversing responses to the four positively stated items (items 4, 5, 7, and 8) and then summing the responses across all scale items. The PSS Scale was used with permission of the American Sociological Association.

The Insomnia Severity Index consists of seven questions related to sleep. The seven questions were combined to get a total score, ranging from 0–7 (no insomnia), 8–14 (subthreshold insomnia), 15–21 (clinical insomnia-moderate severity), and 22–28 (clinical insomnia-severe). The ISI was used courtesy of www.myhealth.va.gov with permission from Charles M. Morin, PhD, at the Université Laval in Quebec City, Canada.

Data Analyses. Paired sample t-tests were used to evaluate the impact of the program on veterans’ scores on the aforementioned indices.

Study Assessment and Results

Sample Characteristics. Over half of the patients (53%) participated in the program. The remaining patients (N = 24) failed to complete the program or the post-intervention assessment. Therefore, their progress was followed using the electronic medical record during the time frame of the study. There were no significant differences found between completers and non-completers in terms of race, age, and ethnicity. The non-completers did not witness a significant change in their pain (P = 0.302) or their weight (P = 0.511) during the time frame of the study.

Among completers, there were no significant differences found on pre/post-intervention measures of pain intensity, waist/hip circumference, walking speed, and insomnia, but they did witness a change in weight (P = 0.000). The average pain intensity at baseline was 4 to 5 on the numeric rating scale, which was indicative of discomfort, needing intervention. Scores on the ISI indicated that patients who completed the program had subthreshold insomnia at baseline, indicating that this sample may not experience too many challenges with sleep disturbances.

Program Outcomes. There were significant differences in outcome measures of medical symptoms/toxicity (t[21] = 2.66, P = 0.015); and perceived stress (t[21] = 3.07, P = 0.006) (see Table 2, page 34). Only perceived stress was significantly different after Bonferroni correction (α = 0.05; P = 0.006). Cohen’s d was calculated giving an effect size of 0.514, which suggested that the program had provided a moderate effect in decreasing perceived stress.

Further inquiry into relevant medical symptom subsystems (eg, head, digestive tract, joint/muscles, weight, energy/activity, mind, and emotions) found a significant change in the head, t(21) = 2.54, P = 0.019, which assessed for headaches and insomnia; joint/muscles, t(21) = 3.05, P = 0.006, which assessed for pain, aches, and arthritis; weight, t(21) = 2.24, P = 0.036; energy/activity, t(21) = 2.46, P = 0.023; and the mind, t(21) = 2.70, P = 0. 013 (see Table 3). However, only joint/muscles was significantly different after Bonferroni correction (α = 0.05; P = 0.007). Cohen’s d was calculated giving an effect size of 0.724 suggesting the program had a moderate to large effect in decreasing joint/muscle symptoms (eg, pain, arthritis).

Discussion

The results of study indicated that veterans who participated in a year-long functional medicine trial achieved significant decreases in perceived stress and joint/muscle symptoms.

There were no significant differences found in self-reported pain intensity, which may speak to how patients may feel married to their pain score despite the pain symptoms being reduced. The participants did note a change in their weight, but again did not witness a significant difference in waist/hip circumference. There was some expectation that the walking speed would not be significant as it is a limited measure. As mentioned previously, there was no significant difference in the measure of insomnia. This may be attributed to the subthreshold insomnia level of the sample at baseline.

Despite all the advances in surgery, technology, and pharmaceuticals, the patient-doctor relationship with hands-on care remains at the heart of sound, effective medical care. In the pilot intervention, not only was the patient and provider relationship deemed important, but the social support given by group members was considered of substantial additional value.

A third level of support was introduced by the Veteran’s Administration (VA) setting. Employees of the VA offered patients respect and gratitude, empathy, and of a level of caring that my be translated as intense caring. This may occur through added services, such as taking them on a walk or wheelchair ride on hospital grounds, referring to them as “our veteran” when discussing their care, welcoming volunteers and chaplains to rotate through the VA hospital, and by having an active social work department and homelessness programs.  

A VA Evidence-based Synthesis Program report, which was released in the past, indicated that group visits focusing on education for the management of chronic conditions in veterans tended to suffer from high levels of attrition, which was substantiated in this pilot. Despite this limitation, the current trial clinic served as a means of initiating the functional medicine matrix while reinforcing the self-management approach to chronic pain management. The group clinic approach of helping our patients become active participants in their own care proved effective for those who were willing to commit to the program.

The authors hope that this study protocol may encourage other VAs to incorporate a version of this low-intensity approach as a benchmark for the future medical care of veterans, as well as for all patients with chronic pain.

The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or any other governmental agency.

 
 
Last updated on: December 7, 2017
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