DIAGNOSTIC PROTOCOL

A. CANADIAN CLINICAL WORKING CASE DEFINITION OF FMS

The two compulsory pain criteria [adopted from the American College of Rheumatology 1990 Criteria[1] are merged with Additional Clinical Symptoms & Signs to expand the classification of FMS into a Clinical Working Case Definition of FMS.
History of widespread pain. Pain is considered widespread when all of the following are present for at least three months: pain in both sides of the body pain above and below the waist (including low back pain) axial skeletal pain (cervical spine, anterior chest, thoracic spine or low back). Shoulder and buttock involvement counts for either side of the body. “Low back” is lower segment.
1.  Pain in at least 11 of the following 18 tender point sites on  palpation. Occiput (2) – at the suboccipital muscle inserts  Low cervical (2) – at the anterior aspects of the intertransverse spaces [the spaces between the transverse processes] at C5 – C7 Trapezius (2) – at the midpoint of the upper border Supraspinatus (2) – at origins, above the scapular spine near its medial border Second rib (2) – just lateral to the second costochondral junctions, on the upper rib surfaces Lateral epicondyle (2) - 2 cm distal to the epicondyles [in the brachioradialis muscle] Gluteal (2) – in upper outer quadrants of buttocks in the anterior fold of muscle Greater trochanter (2) – posterior to the trochanteric prominence Knee (2) - at medial fat pad proximal to the joint line	FMS Tender Points (TrPs)
3. Additional Clinical Symptoms & Signs. In addition to the compulsory pain and tenderness required for research classification of FMS, many additional clinical symptoms and signs can contribute importantly to the patients’ burden of illness. Some of these features are present in most FMS patients by the time they seek medical attention. On the other hand, it is uncommon for any individual FMS patient to have all of the associated symptoms or signs. As a result, the clinical presentation of FMS may vary somewhat, and the patterns of involvement may eventually lead to the recognition of FMS clinical subgroups. These additional clinical symptoms and signs are not required for the research classification of FMS but they are still clinically important. For these reasons, the following clinical symptoms and signs are itemized and described in an attempt to expand the compulsory pain criteria into a proposed Clinical Case Definition of FMS. Neurological Manifestations: Neurological difficulties are often present such as hypertonic and hypotonic muscles; musculoskeletal asymmetry and dysfunction involving muscles, ligaments and joints; atypical patterns of numbness and tingling; abnormal muscle twitch response, muscle cramps, muscle weakness and fasciculations. Headaches, temporomandibular joint disorder, generalized weakness, perceptual disturbances, spatial instability, and sensory overload phenomena often occur. Neurocognitive Manifestations: Some neurocognitive difficulties usually are present. These include impaired concentration and short-term memory consolidation, impaired speed of performance, inability to multi-task, and/or cognitive overload. Fatigue: There is persistent and reactive fatigue accompanied by reduced physical and mental stamina, which often interferes with the patient’s ability to exercise. Sleep Dysfunction: The patient experiences unrefreshing sleep. This is usually accompanied by sleep disturbances including insomnia, frequent nocturnal awakening, nocturnal myoclonus, and/or restless leg syndrome. Autonomic and/or Neuroendocrine Manifestations: These manifestations include cardiac arrhythmias, neurally mediated hypotension, vertigo, vasomotor instability, sicca syndrome, temperature instability, heat/cold intolerance, respiratory disturbances, intestinal and bladder motility disturbances with or without irritable bowel or bladder dysfunction, dysmenorrhea, loss of adaptability and tolerance for stress, emotional flattening, lability, and/or reactive depression. Stiffness: Generalized or even regional stiffness that is most severe upon awakening and typically lasts for hours commonly occurs. It can return during periods of inactivity during the day.

Application Notes

1. Digital Palpation

The palpation examination should be performed with an approximate force of 4 kg./1.4 cm.² (pressure required to partially blanch the blood from under the thumbnail). This force can be standardized by pressing thumb on a weight scale. For a tender point to be considered “positive”, the subject must state that the palpation was painful. “Tender” is not to be considered “painful”.

2. Validity

The two compulsory pain criteria were validated as classification criteria applicable to groups of subjects for the purpose of research study. In that setting they yielded 88.4 percent sensitivity and 81.1 percent specificity. They have not yet been validated for clinical diagnosis of symptomatic individuals in a medical care setting.

3. Focus of the Clinical Working Case Definition

In a clinical setting, the physician must appreciate the spectrum of FMS and the range of distress it can cause. Thus, in addition to identifying FMS using the two compulsory pain features, the clinician should assess the patient for other symptoms and signs that typically embody FMS in order to establish the patient’s total illness burden and direct appropriate treatment in a timely fashion. The following hour-glass diagram indicates the steps to be followed by first narrowing the compulsory pain features to establish the classification of FMS and then expanding the spectrum of the additional symptoms and signs to determine the patient’s total illness burden.

History of Widespread Pain Lasting at Least Three Months
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More of 18 Tender Points Present
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FMS
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Screen for Additional Symptoms & Signs
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Determine Total Illness Burden of Fibromyalgia Syndrome

C. GENERAL CONSIDERATIONS IN APPLYING THE CLINICAL CASE DEFINITION TO AN INDIVIDUAL PATIENT

Continue on in the Consensus Document in the Journal.