• May 2, 2007, Antidepressant drugs: Update to the existing black box warning on the prescribing information on all antidepressant medications to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment.

1. Measure vital signs.
2. Observe general appearance.
3. Assess neck for thyromegaly.
4. Perform bilateral digital palpitation using a force of about 4 kg, which is approximately equal to pressing finger on bathroom scale until it registers 10 pounds, or until the nail bed just begins to blanch; to meet criteria of a positive tender point, patient must label the palpation as "painful", not just tender (Wolfe et al., 1990).
5. Perform a complete musculoskeletal examination, assessing each joint separately.
6. Neurologic assessment
7. Assess mental status and perform a mental health assessment.
8. Fibromyalgia Impact Questionnaire (FIQ) - see www.myalgia.com/FIQ/fiq.pdf

Diagnostic Procedures

1. Laboratory tests: comprehensive metabolic panel (CMP), complete blood count (CBC), thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), sedimentation rate, liver panel, creatinine phosphokinase
2. Psychological analysis: depression scale, suicidal ideation assessment
3. Sleep analysis

Criteria for Diagnosis

1. History of widespread pain present for at least 3 months: Pain is considered widespread when all of the following are present:
   • Pain in the left and right side of the body
   • Pain above and below the waist
   • Axial skeletal pain (cervical spine, anterior chest, thoracic spine, or low back)
   • Shoulder and buttock pain is considered as pain for each involved side.
   • Low back pain is considered lower segment.
2. Presence of 11 out of 18 paired, bilateral tender points as delineated by the American College of Rheumatology (Wolfe et. al., 1990)
   • Occiput: bilateral, at the suboccipital muscle insertions
   • Low cervical: bilateral, at the anterior aspects of the intertransverse spaces at C5-C7
   • Trapezius: bilateral, at the midpoint of the upper border
   • Supraspinatus: bilateral, originating above the scapula spine near the medial border
   • Second rib: bilateral, at the second costochondral junctions
   • Lateral epicondyle: bilateral, 2 cm distal to the epicondyles
   • Gluteal: bilateral, in upper outer quadrants in anterior fold of muscle
   • Greater trochanter: bilateral, posterior to the trochanteric prominence
   • Knee: bilateral, at the medial fat pad proximal to the joint line

Differential Diagnosis

1. Chronic fatigue syndrome
2. Rheumatoid arthritis
3. Sjogren's syndrome
4. Systemic lupus erythematosus
5. Ankylosing spondylitis
6. Polymyalgia rheumatica
7. Inflammatory myositis
8. Metabolic myopathies
9. Hypothyroidism
10. Hyperparathyroidism
11. Cushing's syndrome

Step 1 - Patient and Family Education

1. Validate the diagnosis. Patients need to understand their illness before any medications can be prescribed. They must be reassured that fibromyalgia is a "real" illness (Goldenberg, 2004). (Level III, Recommendation C)
2. Educate about prognosis, pathophysiology, and treatment principles. Lectures, group discussions, and written materials improved outcomes including pain, sleep, fatigue, self efficacy, and quality of life (Goldenberg, Burekhardt, & Crofford, 2004) (Level I, Recommendation A)
3. Fibromyalgia Impact Questionnaire (FIQ). FIQ is a tool to quantitate fibromyalgia's impact over several dimensions of the patient's life, such as function, pain level, fatigue, sleep deprivation, and psychological distress. It is scored from 0 to 100, with 100 being the worst case scenario, with the average being 50 in patients seen in primary care clinics. This tool can be used to monitor the effect of interventions and evaluate patient functional status.

Step 2 - Pharmacological Treatment

1. Adequate sleep. It is proposed that sleep disturbance occurs from a variety of reasons. Some of these reasons include serotonin metabolism in the central nervous system (CNS), resulting in low levels of brain serotonin, low levels of growth hormone secretion, and generalized body pain from the disease process. TCAs help promote restorative sleep and heighten the effects of the body's natural pain-killing substances (endorphins), and increases non-rapid eye movement (non-REM) stage 4 sleep. Low levels of serotonin and norepinephrine are related to depression, muscle pain, and fatigue. Administering TCAs such as amitriptyline helps correct these deficiencies. Recommended dosing is as follows: Amitriptyline 25-50 mg 2 to 3 hours before bedtime, allowing peak sedative effect with minimal carry-over effect. May increase dosing to 50-75 mg over the next weeks if needed for added control. Cyclobenzaprine can be used as an alternative to amitriptyline because of its structural similarity to TCA compounds. The dosage is 10-30 mg at bedtime (QHS). Benzodiazepines are a second alternative, but should be used cautiously at bedtime due to their tendency to stabilize the erratic brain waves that interfere with restorative sleep in patients with fibromyalgia. (Millea & Holloway, 2000) (Level I, Recommendation A)
2. Treat fatigue and depression. If no response with TCAs, consider adding selective serotonin reuptake inhibitor (fluoxetine) in the morning. Dosing for fluoxetine is 20 mg every morning (QAM). This class of drugs works to block the re-uptake of serotonin, which in turn allows the body to utilize greater amounts of serotonin. The exact mechanism of action for fluoxetine in fibromyalgia syndrome is unknown. Since people with fibromyalgia already have decreased levels of serotonin; it is believed that fluoxetine increases the levels of serotonin to the brain. (Note: One research study completed in 2002 found there is a synergistic effect between fluoxetine and amitriptyline due to the pharmacokinetic interaction between the 2 drugs. Using them together may be more effective for the patient's symptoms than using them alone) (Arnold et al., 2002) (Level I, Recommendation A)
3. Treat muscle spasms. Cyclobenzaprine or low dose benzodiazepines (clonazepam) are used to treat muscle spasms. See explanation above for pathophysiological effect of these medications. Cyclobenzaprine also modulates muscle tension at a supraspinal level. Dosing is 10-30 mg every day (QD) or, if greater dosing is needed, divide the doses, with the smaller dose in the morning and the larger dose in the evening (Tofferi, Jackson, & O'Malley, 2004). (Level I, Recommendation A)
4. Adequate pain control. The pain component of fibromyalgia is thought to be abnormal CNS processing of pain signals. It is thought that the pain is caused by a complex interaction between neurotransmitter release, external stressors, patient behavior, hormones, and the CNS system. Tramadol 50-100 mg every 4 to 6 hours is recommended for pain control. Non-steroidal anti-inflammatory agents are not recommended because fibromyalgia is not an anti-inflammatory process. Opioids are not recommended due to adverse side effects and regulatory concerns, and no increased benefit has been noted in research studies (Inanici & Yunus, 2002). (Level I, Recommendation A)

Step 3 - Non-pharmacological Treatment

1. Exercise & Massage. Tender point thresholds are increased with exercise and external muscle stimulation via massage. Exercise has also been shown to decrease the perception of central pain, which is also increased in fibromyalgia patients. The following are recommended methods of exercise and pain control (Level I, II-2, Recommendation B)
   • Cardiovascular fitness training (Gowans & deHueck, 2004)
   • Muscle strengthening/stretching (Gowans & deHueck, 2004)
   • Balneotherapy (Evcik, Kizilay, & Gokcen, 2002)
   • Massage (Hadhazy et al., 2005)
   • Biofeedback (vanSanten et al., 2002)

Step 4 - Procedures. There have been very few studies of tender point or trigger point injection demonstrating its effectiveness. However, due to the complicated nature of pain management in some patients, it should not be ruled out as an alternative means of treatment. Further studies are warranted (Goldenberg, 2004). (Level III, Recommendation C)

Step 5 - Referrals. (for consideration). Referrals may be helpful for patients with severe symptoms and comorbid psychosocial issues, along with those who are non-compliant or who have not received adequate relief with medication therapy and management (Goldenberg, 2004). (Level III, Recommendation C)

• Sleep center
• Mental health professional
• Pain or rehabilitation clinic

Definitions:

Levels of Evidence

Level I: Evidence obtained from at least one properly randomized-controlled trial

Level II-1: Evidence obtained from well-designed control trials without randomization

Level II-2: Evidence obtained from well-designed cohort or case-controlled analytic studies, preferably from more than one center or research group

Level III: Opinions of respected authorities, based on clinical experience; descriptive studies and case reports; or reports of expert committees

Strength of Recommendations

1. There is good evidence to support the recommendation.
2. There is fair evidence to support the recommendation.
3. There is insufficient evidence to recommend for or against, but recommendations may be made on other grounds.

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