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10 Articles in Volume 8, Issue #6
CES for Mild Traumatic Brain Injury
Duloxetine: A New Indication for the Treatment of Fibromyalgia
Evaluating Pain Intervention Effectiveness and Compliance
Low-level Laser Therapy for Trigeminal Neuralgia
Neurobiological Basis for Chronic Pain
Orbital-Inner Canthus Headache due to Medial Temporal Tendonitis
Pain Care for a Global Community: Part 1
Unraveling the Mysteries of Myofascial Pain Syndromes
Vitamin D for Chronic Pain
‘Head to Toe’ Nonprescription Drug History

Evaluating Pain Intervention Effectiveness and Compliance

Innovative ways to identify patients with severe, chronic pain and assess effective pain control by various standardized, objective measures to monitor clinical progress.

Editor’s Note: This article was originally prepared for the 4th Annual VA Pain Management Update in Jackson, Mississippi, June 20, 2008.

Robert Foery, PhD, DABCC/TC

Pain treatment is a relatively new discipline that has not yet significantly addressed the issue of treatment effectiveness or outcomes. Even the diagnosis of pain has been controversial since much debate continues to center around the issue as to whether pain is psychologic or anatomic. The severity of pain is believed by some to be purely whatever the patient says it is on a scale of 1 to 10. Treatment of pain is argued as to whether it should be medical, psychological, or interventional. There is acute, chronic, intractable, malignant, non-malignant, baseline, persistent, breakthrough, rescue, incident, and flare pain, just to name some of the terms promulgated in recent years. Interestingly, the usual terms of mild, moderate, and severe that are applied to all other medical conditions, is conspicuously absent in contemporary pain language. Recently, some opioid drugs have been approved by the US Food and Drug Administration for moderate to severe pain, but there are no guidelines or definitions as to how a clinician is to determine whether pain is moderate or severe. While progress in pain treatment has certainly occurred, the journey has been an arduous process. Presented here is a paradigm in which a sub-class of pain patients is objectively diagnosed as having severe, chronic pain and treated with objective outcome measures of effectiveness. The objective diagnosis and evaluation techniques described here are recommended as a means to eliminate some of the subjectivity that has characterized ambulatory pain treatment.

Biologic Basis of Severe Chronic Pain

The paradigm of diagnosis, treatment, and evaluation of both are based on the following fundamental tenets that have evolved from a plethora of scientific studies.

  1. Severe, chronic pain produces many measurable objective physical signs that can confirm the patient’s perception of severe pain.1-7
  2. Severe, chronic pain produces hyper-function of the hypothalamic-pituitary-adrenal axis and profound hyperelectro-transmission in the peripheral and central nervous systems.4-9
  3. Severe, chronic pain—via its hormonal alterations, cardiovascular affects, and hyperelectro-transmission—causes many pathologic, and even fatal, consequences and complications7-13 (see Table 1). It should, therefore, be considered a disease, per se, and the prevention of its complications and consequences is the basic element of treatment.
  4. Severe, chronic pain may impair eating, ambulation, sleep, activities of daily living, health habits, marital or social relations, and vocational pursuits.4,7
Table 1. Some Complications of Severe, Chronic Pain
  • Hypertension
  • Tachycardia
  • Hypercortisolemia
  • Hyperlipidemia
  • Diabetes
  • Osteoporosis
  • Arteriosclerosis
  • Coronary or Cerebral Vascular Accident
  • Adrenal Exhaustion
  • Fatigue
  • Impotence/Loss of Libido
  • Depression/Suicide
  • Anorexia
  • Insomnia
  • Immobility
  • Loss of Mental Capacity
  • Contractures
  • Body Asymmetry
  • Impaired Activities of Daily Living
  • Loss of Social, Vocational Abilities

The Clinical Diagnosis of Severe, Chronic Pain

Acute, chronic, malignant, non-malignant, and intractable are all terms that describe pain but it is more critical to ascertain if the pain is severe, as opposed to mild or moderate. Again, a knowledge of the underlying cause—be it cancer, non-cancer, rheumatologic, traumatic, or post-surgical—is essential but it is more critical to know if the pain is severe. The premise is that potent (Schedule II) opioid drugs should only be prescribed to severe pain patients rather than those whose pain is classified as mild or moderate.

Severe, chronic pain is diagnosed in this paradigm by not only the patient’s history and perception of severity, but by objective physical signs and laboratory tests. Once a diagnosis of severe, chronic pain has been made, treatment with potent opioids and ancillary measures can be initiated.

The components used to make a diagnosis of severe, chronic pain are listed here. Although no patient will have every component, a diagnosis of severe, chronic pain should demonstrate a majority of these components:

  1. A history of failure of past non-opioid treatments
  2. Impairment of activities of daily living and normal biologic functions
  3. Objective, physical signs of sympathetic discharge and other physical signs
  4. Laboratory evidence of adrenal gland abnormalities

A summary table of diagnosis of severe pain (see Table 2) provides additional detail. Given here are more details of objective physical signs, because a knowledge of these is not well appreciated or utilized. It is the contention of this paradigm that potent opioids should not be used unless objective physical signs of severe, chronic pain are present. Furthermore, treatment effectiveness needs to be objective, and this may be done, in great part, by monitoring objective physical signs.

Table 2. Summary Diagnosis of Severe Pain
  • Patient describes pain as constant and debilitating
  • Objective physical signs of:
    Sympathetic (adrenergic) discharge
    Sensory avoidance
    Positional relief
    Pain distraction
  • Impairment of:
    Activities of daily living
    Diet, sleep, ambulation
    Concentration/memory
    Social, marital, vocational relationships
  • Laboratory evidence of adrenal hormone abnormalities (pregnenolone, and cortisol)

Sympathetic Discharge Signs

Sympathetic or adrenergic discharge is caused by two concomitant mechanisms. Adrenergic receptors in the central nervous system are activated by uncontrolled pain, and these central receptors, in turn, activate the autonomic nervous system by sending electrical impulses downward into the periphery via the vagus nerve and the autonomic nerve network.7-9 The second mechanism is activation of the hypothalamic-pituitary-adrenal axis and the out-pouring of catecholamines (adrenalin, dopamine, and noradrenalin) and glucocorticoids (pregnenolone, cortisol) into the blood stream.5-7

Findings of excess sympathetic discharge can be detected in acute and chronic uncontrolled pain (see Tables 3 and 4). The author has frequently heard the comment that sympathetic discharge signs are only present with acute pain, but these signs are found to occur with any uncontrolled pain. Signs of sympathetic discharge can be detected in non-verbal or comatose patients such as infants or bed-bound elderly. While not all the sympathetic discharge signs are present in every patient, signs such as elevated pulse rate, hypertension, dilated pupil, vasoconstriction, and diaphoresis are seen in every patient whose pain has elevated above a critical threshold that is biologically specific to that person. Sympathetic discharge signs can be quickly and easily assessed in clinical practice. Medical or nursing assistants—or even the patient—can be taught to take a blood pressure and pulse rate that can be verified by the practitioner. A simple feel of hands or feet can detect vasoconstriction, and a light touch of the skin under the eyes is a good place to feel the moisture of excess sweating. Pupil examination will require that fluorescent lights be turned off.

Table 3. Sympathetic Discharge Signs
  • Tachycardia
  • High Blood Pressure
  • Dilated Pupil
  • Vasoconstriction (Cold Hands Or Feet)
  • Diaphorosis
  • Hyperreflexia
  • Insomnia
  • Nausea, Diarrhea
  • Anorexia

The author recommends that patients with severe, chronic pain attempt to keep their pulse rate under about 88 per minute and their blood pressure below about 130/90mmHg. Normal pupil diameter is approximately 3.0 to 5.0mm (see Table 4).

Table 4. Recommended Objective Measures To Help Determine Uncontrolled Pain
Uncontrolled Pain Good Pain Control Excess Opioids
Pulse rate > 88 per minute Pulse between 64 and 88 per minute Pulse rate
Blood pressure > 130/90mmHg Blood pressure between 110/70 and 130/90mmHg Blood pressure
Pupil diameter > 5.0 Pupil diameter between 3.0 and 5.0mm Pupil diameter
Cold hands/feet Normal temperature Very warm hands/feet

Positional Relief Signs

Patients who “hurt” with some movement or physical function will attempt to avoid pain by finding a comfortable position. They may do this over a period of months to years and leave telltale physical signs that are easily observable (see Table 5). In its simplest form, positional relief is present in the patient who walks with a limp, drags a foot, or walks off-balance. Others can be observed in the patient who leans in one direction to relieve back pain or the headache patient who frowns on one side. In these cases, a permanent crease on one side of the back or forehead can be detected. If the patient seeks positional relief long enough, some muscle groups hypertrophy to compensate for the extra load while others may atrophy due to minimal use. Patients who walk abnormally to seek pain relief may have one shoe sole that wears down in one spot compared to the opposite shoe.

Table 5. Common Positional Relief Signs
  • Walks imbalanced wide gait, foot drag, (shoes don’t wear evenly)
  • Leans while sitting or standing
  • Lies on floor
  • Sits on edge of chair
  • Looks straight ahead (won’t turn head)
  • One shoulder raised or lowered
  • Forehead crease on one side
  • Muscle hypertrophy or atrophy of back muscles
  • Difference in temperature between sides

The basic physiologic problem with long-term attempts to utilize positional relief is that some body parts become asymmetrical. Rather than a balance of two equal sides, one side becomes overused with subsequent muscle hypertrophy and possibly degeneration of joints. For example, a patient with a painful right knee will over-load and over-use the left hip and knee and may develop degenerative arthritis and pain in the left hip and knee. The side of the body that is in pain, favored, and underused will undergo muscle atrophy and, possibly, contractures. For example, patients with a severe, painful neuropathy in one extremity may develop permanent atrophy and contractures to the point that the extremity is functionless. The atrophic side will often become cool to the touch as circulation also apparently decreases in the area. Fundamentally, the practitioner should look for physical, objective signs of asymmetry when evaluating a chronic pain patient. Unless severe pain is controlled, physical signs of asymmetry in the affected area of the body will invariably emerge.

Sensory Avoidance Signs

Closely related to positional relief is sensory avoidance. The obvious example of sensory avoidance is a painful area that gets more painful to touch. Uncontrolled pain hyperstimulates the autonomic nervous system, so practically any sensory input may cause additional pain (see Table 6). The classic case is the migraine patient who turns out the lights, lays alone in a room, and covers their head and eyes. This patient hurts worse with any sensory input including light, noise, smell, eating, or movement. Some extremely painful conditions such as reflex sympathetic dystrophy (Chronic Regional Pain Syndrome), adhesive arachnoiditis, and diabetic peripheral neuropathy produce such pain that even light touch is unbearable (allodynia). In these cases, patients may not wear clothes or allow a sheet to cover themselves. They may not wear shoes or socks. Patients with neuropathies of the face, head, and neck may not brush their teeth, shave, or comb their hair. Any attempt by the examiner to touch the affected area will be met with immediate withdrawal of the body part and a sudden “no” from the patient.

Table 6. Common Sensory Avoidance Signs
  • Speaks slowly, softly, hesitantly
  • Wears sunglasses/ stays in dark
  • Delays answering questions
  • Wears hat
  • Walks slowly, deliberately, and with wide gait, limp, or foot drag
  • Stares or looks straight ahead
  • Avoids noise
  • Shallow breathing
  • Doesn’t eat or drink
  • Wears loose or no clothes over painful areas
  • Won’t brush teeth, shave, or comb hair

Patients with painful conditions of the upper torso, including fibromyalgia, abdominal adhesions, or cervical spine conditions may speak slowly, softly, and with hesitancy, lest a forceful voice and the effort of speaking produce more pain. Often, patients in severe pain will sit on the edge of their chair and stare straight ahead, because leaning back or turning their head is painful. Patients with spinal or abdominal diseases may breathe so slow and shallow that their carbon dioxide (CO2) levels increase.2

Pain Distraction Signs

When a patient is in severe pain, they may not only attempt to avoid sensory input and find positional relief, they may also attempt maneuvers or techniques to distract their attention away from their pain (see Table 7). An old joke describes this maneuver as the doctor who hammers the patient’s hand so he’s distracted from the pain of his slipped disc. With severe, pain, however, a similar phenomena may occur that can sometimes be physically detected by the practitioner. Grinding of the teeth can sometimes be detected by whittled-down teeth. Lip-biting and fist-clenching are common. Less commonly observed is overheating of a painful area with a hot water bottle or heating pad. Sometimes, permanently mottled skin or actual burns can be observed. Some rare patients become so tortured with pain that they will bang their head, fist, or foot against a wall, and the trauma of this activity may be evident. Cigarette burns may be intentionally self-inflicted.

Table 7. Common Pain Distraction Signs
  • Grinds/grits teeth
  • Clenches knuckles/toes
  • Overheats skin (may show permanent burn marks)
  • Hits head, fist, or foot against wall
  • Cigarette burns
  • Bites lips
  • Gouges or squeezes skin

At-Home Blood and Pulse Monitoring

Chronic pain has a baseline or persistent component, as well as breakthrough pain or pain flares. It is for this reason that patients should be taught to take their BP and pulse at home when breakthrough pain or flares occur. This can be done by use of contemporary BP/pulse monitoring devices that can be cheaply obtained at most pharmacies or large retail outlets. Patients should keep an at-home record and bring this to their practitioner for review. In this manner, practitioners can determine if their medical regimen is effectively controlling pain while the patient is outside the clinical setting. In addition, patients and their families need to know that severe, chronic pain raises blood pressure and/or pulse rate, and that these elevations may lead to the cardiovascular complications of coronary artery disease and cerebral vascular accidents (strokes). Once patients and families see that the blood pressure and pulse rate go up with pain intensity, it is easy for the practitioner to educate the patient that a rise in adrenalin and cortisol is occurring and producing elevated blood lipids and glucose which may further hasten the development of arteriosclerosis and diabetes. Fundamentally, chronic pain of enough severity will cause sympathetic discharge and this physiologic phenomenon is a profound cardiovascular risk.10-13

Critical Importance of Physical Signs in Regulating Opioid Dosages

Today there are many drug seekers as well as relief seekers. New patients who are initially evaluated should be physically examined for the objective, physical signs of severe pain that are presented as a checklist in Figure 1. If none are found, non-opioid treatments should be satisfactory for pain treatment. If a practitioner encounters a questionable patient, the patient’s close family members can usually verify behavioral signs compatible with positional relief, sensory avoidance, or pain distraction attempts.

Figure 1. Physical Examination for Severe, Chronic Pain

Patients who are in ongoing, ambulatory opioid treatment will periodically require an adjustment in opioid dosage. Upward increases in opioid dosages should be done if the patient’s complaints of uncontrolled pain are confirmed by evidence of excess sympathetic discharge such as tachycardia, hypertension, cold hands, or dilated pupil. For example, a patient who states their pain is an 8 out of 10 and demonstrates a pulse rate of 100 and a pupil dilated above 5.0mm in diameter warrants a higher opioid dosage or an additional opioid. On the contrary, if the same patient demonstrates a normal blood pressure, pulse rate, and pupil size, an adjustment in opioid dosage should be postponed for later evaluation. In this case, a daily at-home tracking of pulse and blood pressure and interview with the family would be in order.

Outcome Evaluation

In this paradigm, the outcomes of treatment are far more critical and important than any particular drug, therapy, or counseling. Outcomes are not just pain relief, but improvements in biochemical, physiologic, functional, and quality of life measures. On-going evaluation can easily be done at each clinic visit by written patient questionnaires (see Figures 2-4).

Short Term Evaluation

Within a short time after treatment is initiated an objective assessment should be done (see Table 9). In general, the author recommends a 60–90 day time-frame. This evaluation should consist of three components:

  1. Pain Relief to Eliminate Emergency Room Visits
  2. Biochemical Stabilization
  3. Health and Function Stabilization

An unappreciated goal of treatment of severe pain is success in keeping the patient out of the emergency room and hospital, since most severe pain patients frequently seek help at these institutions prior to effective treatment. Figure 2 is a sample 60 – 90 day questionnaire given to our severe pain patients to help determine if treatment is beginning to work.

Figure 2.Sixty- to Ninety-day Treatment Assessment.

Figure 3.Are You Getting Better?

Pain Relief

Although it is standard practice to ask patients to evaluate their pain on a 1 to 10 scale, this scale is, by itself, inadequate to evaluate on-going pain control. Once pain control begins to occur, the pain scale may “shift” or “re-adjust” in the patient’s mind to the point that the patient always reports an 8, 10, or “worst ever” even though they have visibly improved. Other evaluative questions such as “do you believe your pain has improved or is it better controlled than before” are more revealing. Questionnaires (illustrated in Figures 2 and 3), given to pain patients at each clinic visit, provide a better on-going assessment.

Biochemical Evaluation

Some of the most serious medical complications of pain can be detected and evaluated by laboratory testing at the time of treatment initiation and at periodic follow-ups. It is highly recommended that severe pain cases have an initial, adrenal hormone screen of early morning pregnenolone and cortisol. Either high or low serum levels indicate severe pain4,5,7; low pregnenolone and/or cortisol represent adrenal exhaustion and hormone replacement may be necessary. In the author’s view, however, immune, lipid, and electrolyte monitoring is still early in research and are not yet recommended for routine evaluation.

On-Going Evaluation

Our severe pain patients are followed monthly for at least 6 to 12 months before a less frequent clinic attendance schedule is allowed. During this initial period, family members must be involved in the treatment process.

Goals are to not only provide pain relief but help the patient do the following:

  • develop an at-home treatment program,
  • determine if he/she is “getting better” (see Figure 3), and
  • build a quality life (see Figure 4).

Figure 4.Building a Quality Life — Major Activities

Also, at each visit, blood pressure and pulse rate are monitored to determine if sympathetic discharge is being adequately suppressed. If there is a question, the patient is requested to monitor BP and pulse rate at home.

Summary

Proper evaluation of pain treatment requires, like any other medical condition, that all patients have a treatment entry diagnosis that is defined, standard, and objectively determined. Outcomes need to be clear and easily assessed among all patients in treatment. Presented here is an paradigm to identify pain patients who have a diagnosis of severe, chronic pain, and whose treatment is assessed by various objective measures to monitor clinical progress. Severe chronic pain patients, as defined and identified here, may have to be in opioid treatment for many years—if not a lifetime. While the objective measures and definitions presented here are admittedly new and undoubtedly preliminary in sophistication relative to the future, they represent a structured paradigm with examples for future investigation.

Last updated on: January 30, 2012
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