Disclosure This program was developed from an educational grant from Pfizer to the University of...

DisclosureDisclosure

This program was developed from an educational grant from Pfizer to the University of Calgary and Université de Sherbrooke.

Faculty disclosure

Core Development Committee Core Development Committee

Dr. Christian Cloutier, Neurosurgeon, QuebecDr. Mary-Ann Fitzcharles, Rheumatologist, QuebecDr. Algis Jovaisas, Rheumatologist, Ontario Ms. Christal Lacombe, Pharmacist, AlbertaDr. Rhonda Shuckett, Rheumatologist, British ColumbiaDr. Richard Ward, Family Physician, Alberta

National CommitteeNational Committee

Dr. Brian Craig, Family Physician, New BrunswickDr. Alan Kaplan, Family Physician, OntarioDr. Bernard Martineau, Family Physician, QuebecDr. Kenneth Stakiw, Family Physician, SaskatchewanMr. Robert Thiffault, Pharmacist, Quebec

Overall Learning ObjectivesOverall Learning Objectives

Following this program, participants willDescribe the diagnosis and core symptoms of fibromyalgia (FM) Have an approach to explaining the diagnosis of FM to patientsPrescribe appropriate pharmacologic and non-pharmacologic interventions based on predominant symptoms

Menu (all related to FM)Menu (all related to FM)

Click on the name of the module you want to access

Management of PainManagement of Pain

FatigueFatigue

Sleep DisturbanceSleep Disturbance

Non-pharmacologic Interventions

1

2

3

7

DepressionDepression 4

Making the DiagnosisMaking the Diagnosis 5

““Selling” the DiagnosisSelling” the Diagnosis 6

Choice of Medical Choice of Medical TherapyTherapy 8

Incomplete Treatment Incomplete Treatment ResponseResponse 9

ObjectivesObjectives

Following this module, participants will be able to:Explain the basis of increased pain in patients with fibromyalgia (FM)Discuss the relationship between pain, fatigue and sleep disturbance in FMSuggest non-pharmacologic therapies for painPrescribe medications that improve pain in FMRecognize the role of an interdisciplinary team in FM management

• Chronic, widespread pain is the defining feature of fibromyalgia

• Patient descriptors of pain include: aching, exhausting, nagging, and hurting

• Presence of tender points

Widespread PainWidespread Pain

• Characterized by non-restorative sleep and increased awakenings

• Abnormalities in the continuity of sleep and sleep architecture


• Patients describe it as physically or emotionally draining

FatigueFatigue

Core Clinical Features of FMCore Clinical Features of FM

StiffnessStiffness• Stiffness in the morning is a common

characteristic of FM

• Characterized by confusion, slowed processing of information and reaction time, difficulty in word retrieval or speaking, concentration, attention, short-term memory consolidation, disorientation

Neurocognitive ImpairmentNeurocognitive Impairment(“Fibro Fog”)(“Fibro Fog”)

ACR Fibromyalgia Diagnostic Criteria. 2010. http://www.nfra.net/Diagnost.htm; Carruthers et al. J Chron Fat Synd. 2003;11:7-115; Harding. Am J Med Sci. 1998;315:367-37; Henriksson. J Rehabil Med. 2003;(suppl 41):89-94; Leavitt et al. Arthritis Rheum. 1986;29:775-781; Roizenblatt et al. Arthritis Rheum. 2001;44:222-2306; Wolfe et al. Arthritis Rheum. 1995;38:19-28.

• Chronic, widespread pain is the defining feature of FM



Widespread Pain

Case StudyCase Study

Patty is a 32-year-old patient in your practice who was diagnosed with FM that appeared to start after she slipped on some ice. Patty was advised to attend a local yoga studio, which has a special FM class. She was given a morning medication that targeted mood. As well, she was referred to a local FM support group.

Video 1Video 1

QuestionsQuestions

1. Why do patients with FM have pain?

2. What non-medication approach would you take with Patty?

3. What medical FM therapies improve pain?

4. How could an interdisciplinary team (your own team or resources in your community) assist in the management of patients with FM?

Take the time to answer each of the questions

Symptoms of FMSymptoms of FM

Pain, fatigue and sleep disturbance are present in at least 86% of patients*

0

20

40

60

80

100100%

96%

86%

72%

60%56%

52%46%

42% 41%

32%

20%

Muscularpain

Fatigue Insomnia Jointpains

Head-aches

Restlesslegs

Numbness and

tingling

Impairedmemory

Leg cramps

Impaired Concen-tration

Nervous-ness

Major depression

*United States dataACR 1990 Fibromyalgia Diagnostic Criteria. National Fibromyalgia Research Association Web Site http://www.nfra.net/Diagnost.htm.

Pathophysiological Observations in FMPathophysiological Observations in FM

Despite extensive research, the exact cause of pain in FM is not clearly understood

PeripheralPeripheral sensitizationTemporal summation (windup) (short-term)

Spine and brainCentral sensitization (long-term)Change in grey matter volume

Descending inhibitionOther factors

Hypothalamic-pituitary-adrenal axis dysregulationSleep disturbanceCognitive effects

Staud et al. Nat Clin Pract Rheumatol. 2006;2:90-98; Henriksson. J Rehabil Med. 2003;41(suppl 41):89-94; Crofford et al. Arthritis Rheum. 2002;46:1136-1138; Vaerøy et al. Pain. 1988;32:21-26; Staud. Arthritis Res.Ther. 2006;8:208.

Key Messages for Pain Principles in FM

Key Messages for Pain Principles in FM

There is no “cure” for the painActive patient involvement: activity and non-medication approaches Important to manage patient’s expectationsNormalize sleepNormalize moodStart with medical interventions for pain that have evidence for efficacy in FM

Start low, go slow!

Target pain control that allows functionality

Non-pharmacologic TreatmentsNon-pharmacologic Treatments

Patient educationConflicting evidence but some studies have shown improvements in pain, sleep, fatigue and quality of life

Cognitive-behavioural therapyPositive effects on coping with and control over pain

• Not proven to improve pain Proven to improve physical functionShould be done by a trained professional

Aerobic and strengthening exercisesReduce pain, increase self-efficacy, improve quality of life and reduce depression Aerobic exercise should be of low to moderate intensity, 2–5 times/week

Goldenberg et al. JAMA. 2004;292:2388-2395.Brosseau et al.; Ottawa Panel Members. Phys Ther. 2008;88:873-886.Brosseau et al.; Ottawa Panel Members. Phys Ther. 2008;88:857-871.

Modulating Factors of FM Syndrome Pain

Modulating Factors of FM Syndrome Pain

Wallace et al. Fibromyalgia and Other Central Pain Syndromes. Lippincott Williams & Wilkins; 2005:126.

Factors Mean %Exacerbating Factors

Weather (cold/humid) 65

Poor sleep 70

Anxiety/stress 61

Physical inactivity 49

Noise 22

Relieving Factors

Local heat 58

Rest 54

Moderate activities 46

Massage 40

Stretching exercises 43

Sleep interference can directly result from and/or contribute to FM

Psychological symptoms are

strongly associated with FM

Management strategy for FM patients

is to improve overall patient functionality



Adapted from Argoff. Clin J Pain. 2007;23:15-22.

Interrelationship Among Pain, Sleep Disturbance and Psychological Symptoms


Paradigm of pain Paradigm of pain

FunctionalImpairmentand Fatigue

Pain Related

Sleep Deprivation and PainSleep Deprivation and Pain

Activates, maintains central nervous system (CNS) areas responsible for awake state

Dampens areas responsible for initiation and maintenance of sleep

May impair healing, leading directly to pain

Affects CNS areas responsible for coping mechanisms useful for dampening pain experience

Chronic painChronic pain Lack of sleepLack of sleep

Sleep disturbances may lead directly to more pain, and indirectly to a heightening of the pain experience through impairment of usual adaptive mechanisms.

Call-Schmidt, Richardson. Pain Manag Nurs. 2003;4:124-133.

Best Evidence: FM Pain MedicationBest Evidence: FM Pain MedicationMedication Mechanism of

ActionEffect on Pain

Effect on Other Symptoms

Off/on Label Indication

Comments Starting Dose and Titration

Usual Maintenance Dose

Amitriptyline (desipramine, doxepin, nortriptyline)

TCA(NE > 5HT)

+ Sleep, anxiety

Off Poor long term, doxepin seldom recommended, desipramine may cause insomnia (administer in morning), not well tolerated in this population

10-25 mg/day Increase weekly by 10 mg/day

50-150 mg/day

Cyclobenzaprine Muscle relaxant (NE)

+ Sleep Off Poor long term 10 mg 3 times/day 10 mg 3 times/day (range of 20-40 mg/day in divided doses, max 60 mg/day)

Duloxetine SNRI +++ Depression, anxiety

On 60 mg/day

(can start at 30 mg for tolerability reasons with target of 60 mg/day in 1-2 weeks)

60-120 mg/day

Gabapentin 2 binding: ↓neuronal excitation

++ Sleep, anxiety

Off 300 mg 3 times/day; increase with 300- or 400-mg capsules, or 600- or 800-mg tablets 3 times/daily

3 times/day up to 1800 mg/day

Pramipexole Dopamine agonist

+ Fatigue Off Limited population studied

Start 0.375 mg/day in 3divided doses; increase gradually no more frequently than every 5-7 days

1.5 to 4.5 mg/day in equally divided doses 3 times/day

Pregabalin 2 binding: ↓neuronal excitation

+++ Sleep, anxiety

On 150 mg/day in 2 divided doses; increase by 150 mg/day after 1 week

300-450 mg in 2 divided doses

Tramadol Opioid agonist SNRI

++ Off 25 mg/day; increase by 25 mg/day every 3 days to 50 mg 4 times/day

50-100 mg 4 times/day

GABA, γ-aminobutyric acid; NE, norepinephrine; SNRI, serotonin-norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; TCA, tricyclic antidepressant

(alphabetical order)(alphabetical order)

+++: strong evidence for use/efficacy; ++: moderate evidence use/efficacy; +: some evidence use/efficacy; -: no evidence for use/efficacy

No/Poor Evidence: FM Pain Medication No/Poor Evidence: FM Pain Medication

Medication Mechanism of Action

Rationale for Use Concern for Use

Benzodiazepines GABA increase Anxiety AddictionSide effects

Cannabinoids CB 1 receptor agonist

Improves sleep Lack of effectiveness in FM painSide effects

NSAIDs Prostaglandin inhibition

Analgesia NSAID-related side effects

Opioids Opioid receptor agonists

Analgesia AddictionSide effectsSee new national guidelines

NSAID, non-steroidal anti-inflammatory drug


Video 2Video 2

Video de-briefVideo de-brief

SummarySummary

Pain is the most common symptom of FMSet realistic treatment goals Use non-pharmacologic treatments firstUse medical therapies that target pain and have evidence for efficacy in FM as first-line pharmacotherapyBalance medication side effects and risk with optimizing function

Menu


Following this module, participants will be able to: Provide a differential diagnosis of fatigue in patients with fibromyalgia (FM)Prescribe therapies that will improve fatigue in FMAssist patients in establishing reasonable treatment goalsRecognize the role of an interdisciplinary team in FM management











FatigueFatigue






Fatigue


Patty is a 32-year-old patient in your practice who was diagnosed with FM that appeared to start after she slipped on some ice. Patty signed up at a local gym to take aerobic exercise classes at your suggestion. She was given a bedtime medication to improve her sleep and referred to a website that provides information for patients with FM.

Video 1Video 1

QuestionsQuestions

1. In patients with an established diagnosis of FM, what factors should be considered when evaluating fatigue?


3. What FM medications target fatigue?

4. How could an interdisciplinary team (your own team or resources in your community) assist in the management of patients with FM? What other healthcare professional could help?




0

20

40

60

80

100100%

96%

86%

72%

60%56%

52%46%

42% 41%

32%

20%

Muscularpain


Head-aches

Restlesslegs

Numbness and

tingling

Impairedmemory

Leg cramps


Nervous-ness

Major depression

*United States data

ACR 1990 Fibromyalgia Diagnostic Criteria. National Fibromyalgia Research Association Web site http://www.nfra.net/Diagnost.htm.

Things to Consider when FM Patients Complain of Fatigue

Things to Consider when FM Patients Complain of Fatigue

1. Sleep disturbance2. Uncontrolled pain3. Depression4. Unrealistic expectations5. “Stress” caused by illness6. Medication side effects

(especially polypharmacy)7. Deconditioning8. Unrecognized new illness*

* Avoid the trap of re-investigating the patient with firmly diagnosed FM, but remember: eventually all FM patients will get another disease!

1. Musculoskeletal (19.4%)2. Psychosocial (16.5%)3. Gastrointestinal (8.1%)4. Neurological (6.7%)5. General (4.9%)6. Respiratory (4.9%)7. Endocrine (2.8%)8. Cardiovascular (1.9%)9. Menopause (1.1%)10. Malignancy (.7%)

46.9% of those with the initial presentation of fatigue and with no diagnosis made at the time of presentation had, at the end of one year, one or more of these diagnoses that could possibly be the cause of their fatigue.

Fatigue in Primary Care – One-Year Follow-Up

Fatigue in Primary Care – One-Year Follow-Up

Note that of musculoskeletal complaints, most were deemed non-specific.

Documentation at initiation of study indicated that 24.1% of patients had depressive symptoms. Diagnosis of depression was made in 4.9% of subjects at one year.

Nijrolder et al. CMAJ. 2009;181:683-687.








Adapted from Argoff. Clin J Pain. 2007;23:15-22





Pain Related








Call-Schmidt, Richardson. Pain Manag Nurs. 2003;4:124-133

Utility of FM Medications Targeting Fatigue

Utility of FM Medications Targeting Fatigue

There are no generally accepted, on-label medications that improve

the fatigue associated with FM

Physical activity is the only non-pharmacologic strategy proven

to reduce fatigue

What is helpful for complaints of fatigue?What is helpful for complaints of fatigue?

Improvement of sleep hygieneModerate physical activityPacingRealistic goal settingHealthy eatingCognitive behavioral therapy (CBT)

Lera et al. J Psychosom Res. 2009;67:433-441.Rossy et al. Ann Behav Med. 1999;21:180-191.Williams. Best Pract Res Clin Rheumatol. 2003;17:649-665.

Medications with Anti-fatigue Properties Medications with Anti-fatigue Properties


Effect on Fatigue


Comments

Bupropion NEDopamine

- Depression More “energizing” antidepressant

Duloxetine SNRI + Pain, depression, anxiety

Improvement in fatigue as secondary endpoint

Modafinil DopamineNE

+ Open label small study


+ Pain Off label - limited population studied

Stimulants (methylphenidate, dextroamphetamine)

NEDopamine

- No evidenceAddiction properties so caution



NE, norepinephrine; SNRI, serotonin-norepinephrine reuptake inhibitor

Video 2Video 2

SummarySummary

When fatigue is the primary complaint, evaluate sleep and pain control, and rule out depressionUse of medications may improve fatigueHelp patients set realistic goals for improvement of fatigueImportant role of non-pharmacologic interventions, especially physical activities

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Following this module, participants will be able to: Recognize the relationship between sleep restoration and symptom improvement in patients with fibromyalgia (FM)Provide non-pharmacologic therapies to improve sleep disturbancePrescribe medications that target sleep and other FM symptomsRecognize the role of the interdisciplinary team in FM management











FatigueFatigue









Patty is a 32-year-old patient in your practice who was diagnosed with FM that appeared to start after she slipped on some ice. Patty was advised to attend a local yoga studio, which has a special FM class. She was given a morning medication that targeted mood and pain. She was encouraged to review a website that provides information for patients with FM.

Video 1Video 1

QuestionsQuestions

1. What elements should you consider when evaluating Patty’s sleep problems?


3. What FM medications improve sleep problems?





0

20

40

60

80

100100%

96%

86%

72%

60%56%

52%46%

42% 41%

32%

20%

Muscularpain


Head-aches

Restlesslegs

Numbness and

tingling

Impairedmemory

Leg cramps


Nervous-ness

Major depression

* United States data


Pain

Poor sleep hygiene

Medication side effects (including caffeine)

Anxiety/depression/bipolar disorder

Other sleep disorders (restless leg syndrome, obstructive sleep apnea, etc.)

Differential Diagnoses to Consider with Sleep Disorders

Differential Diagnoses to Consider with Sleep Disorders








Adapted from Argoff. Clin J Pain. 2007;23:15-22.





Pain Related








Call-Schmidt, Richardson. Pain Manag Nurs 2003;4:124-133.

Pain Leads to Sleep DisruptionPain Leads to Sleep Disruption

Result of noxious pain stimuli = arousalDecrease in delta wavesIncrease in alpha waves

In FM: the structure of the sleep is modified and there is fragmentation of sleep

Drewes et al. Sleep. 1997;20:632-640.

Non-pharmacologic Interventions to Improve Sleep

Non-pharmacologic Interventions to Improve Sleep

1. Avoid stimulants

2. Regular time to go to bed and to rise

3. Avoid napping through day

4. Regular AM exercise

5. Bed is for sleep and sex

6. Relaxation before bed

7. Sleep handout for patients

www.tufts.edu/med/phfm/pdf/fm-handouts/SleepHygiene.pdf

Medications and Effects on SleepMedications and Effects on Sleep

Medication Effect on Sleep Effect on Pain

Amitriptyline (desipramine, doxepin, nortriptyline)

+++ + (poor long-term)

Atypical antipsychotics +++ ±

Benzodiazepines +++ -

Cannabinoids +++ +

Cyclobenzaprine +++ + (poor long-term)

Duloxetine + +++

Gabapentin ++ ++

Pregabalin +++ +++

Zopiclone +++ -


Evidence for effect on sleep is mostly within non-pain patients and has been collected by polysomnography. The only evidence from patients with pain is with pregabalin through patient diaries and Medical Outcomes Study Sleep scores


Video 2Video 2

SummarySummary

Rule out secondary causes of sleep disordersConsider lifestyle modification as a first step to manage sleep problemsConsider pain/sleep/fatigue cycle when considering therapiesUse medical therapies that target sleep when it is prevalent disabling symptom

Menu


Following this module, participants will be able to:Differentiate fibromyalgia (FM) from depressionPrescribe therapies that will improve both FM and depressionHave an approach to explaining depression and FM to patientsUse an interdisciplinary team to manage patients with FM











FatigueFatigue






Patty is a 32-year-old patient in your practice who was diagnosed with FM that appeared to start after she slipped on some ice. Patty was referred to a “Living with FM” lifestyle program run by a local physiotherapist. She was advised to work on lifestyle and sleep hygiene, and to use a simple over-the-counter analgesic for pain control. She presents for follow-up complaining that the interventions are “not effective.”

Video 1Video 1

QuestionsQuestions

1. Is FM just depression with pain?2. What treatment modalities may be indicated in

this patient?3. How would you convince Patty that an

antidepressant medication would be a good choice?



Symptoms in FM SyndromeSymptoms in FM SyndromeSYMPTOMS MEAN

(%)

Musculoskeletal

Pain at multiple sites 100

Stiffness 76

“Hurt all over” 62

Swollen feeling in tissues 52

Non-musculoskeletal

General fatigue 87

Morning fatigue 75

Sleep difficulties 72

Paresthesia 54

Dizziness/vertigo 59

Tinnitus 17

Sicca symptoms 15

Raynaud phenomenon 14

SYMPTOMS MEAN (%)

Non-musculoskeletal

Anxiety 60

Mental stress 61

Depression 37

Cognitive dysfunction 61

Selected Associated Syndromes

Headaches 54

Dysmenorrhea 43

Irritable bowel syndrome 38

Restless legs syndrome 31

Female urethral syndrome

15

Wallace et al. Fibromyalgia and Other Central Pain Syndromes. Lippincott Williams & Wilkins; 2005:126.

Anxiety disorder

Any psychiatric disorder

Mood disorder

100

80

60

40

20

0

100

80

60

40

20

0

How Patients with Psychiatric Disorders Initially Present to

Primary Care Physicians1

How Patients with Psychiatric Disorders Initially Present to

Primary Care Physicians1

Psychological

83%

Somatic

17%

Strong Correlation Between Number of Physical Symptoms and

Prevalence of Psychiatric Disorders2

Strong Correlation Between Number of Physical Symptoms and

Prevalence of Psychiatric Disorders2

The more physical complaints there are, the more likely there is a psychiatric problem.

Pat

ien

ts w

ith

psy

chia

tric

dis

ord

ers

(%)

Number of physical complaints 2-3 4-5 6-8 ≥9

Most people with psychological problems go to their family doctor with a physical complaint rather than recognizing that they have a form of mental distress.

1. Kirmayer et al. Am J Psychiatry. 1993;150:734-741. 2. Kroenke et al. Arch Fam Med. 1994; 3:774-779.

0-1

Symptom Psychiatric Healthy

Tired, lack of energy 85% 40%

Headache, head pains 64% 48%

Dizzy or faint 60% 14%

Parts of body felt weak 57% 23%

Muscle pains, aches, rheumatism 53% 27%

Stomach pains 51% 20%

Chest pains 46% 14%

Adapted from Kellner R and Sheffield BF. Am J Psychiatry. 1973;130:102-105.

Somatic SymptomsCommon in Psychiatric Patients

Somatic SymptomsCommon in Psychiatric Patients

Maintain a High Index of Suspicion for the Diagnosis of Major Depressive Disorder

Maintain a High Index of Suspicion for the Diagnosis of Major Depressive Disorder

In patients with:Multiple physical symptomsFrequent visits and thick chartsPoor sleep, fatigue Chronic pain (including FM, migraines, irritable bowel syndrome)Anxiety disordersSubstance-use disordersAttention-deficit/hyperactivity disorderType II diabetes, ischemic heart disease, cerebrovascular accidents, cancer, osteoporosis

Mood Disorders in FMMood Disorders in FM

At time of diagnosis, approximately 20%–40% of individuals with FM have an identifiable current mood disorder (e.g., depression or anxiety)

Lifetime prevalence of depression: 74%

Lifetime prevalence of anxiety disorder: 60%

In many cases, depression or anxiety may be the result of chronic pain

Katon et al. Ann Intern Med. 2001;134:917-925.Boissevain et al. Pain. 1991;45:227-238.Boissevain et al. Pain. 1991;45:239-248.Giesecke et al. Arthritis Rheum. 2003;48:2916–2922.Arnold et al. Arthritis Rheum. 2004;50:944–952.Fishbain et al. Clin J Pain. 1997;13:116–137.

Strategy for Explaining DepressionStrategy for Explaining Depression

Reinforce neurobiological basis of depression

Acknowledge that chronic pain and depression frequently co-exist

Use the symptom complex for depression –SIGECAPS – to help patients understand symptom grouping

Encourage bibliotherapy to reinforce concepts

Use other members of healthcare team to assist in psychoeducation

SIGECAPS, mnemonic mnemonic for symptoms of major depression and dysthymia (sleep disorder, interest deficit, guilt, energy deficit, concentration deficit, appetite disorder, psychomotor retardation or agitation, suicidality)

Non-pharmacologic TreatmentNon-pharmacologic Treatment

Evidence for effectiveness of cognitive behavioral therapy (CBT) for both depression and FM

Bennett et al. Nat Clin Pract Rheumatol. 2006;2:416-424.Whitfield et al. Advances Psychiat Treat. 2003;9:21-30.

Medications for FM that Have Mood Regulation and Anxiolytic PropertiesMedications for FM that Have Mood Regulation and Anxiolytic Properties


Effect on Mood/Anxiety


Off/on- Label Indication For FM

Comments

Amitriptyline(desipramine, doxepin, nortriptyline)

TCA(NE > 5HT)

+ Pain, sleep Off FM doses < usual antidepressant dose

Bupropion Atypical anti-depressant

++ Fatigue Off More “energizing” antidepressant

Duloxetine SNRI +++ Pain On


++ Pain, sleep Off Address anxiety reduction properties


+++ Pain, sleep On Address anxiety reduction properties

Sertraline SSRI ++ Pain Off Compared versus physical therapy

Venlafaxine SNRI > SSRI ++ Pain Off Open-label small studies, limited effect on FM pain

GABA, γ-aminobutyric acid; NE, norepinephrine; SNRI, serotonin-norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; TCA, tricyclic antidepressant



Video 2Video 2

SummarySummary

FM is common, depression is common. They frequently occur together but are separate disorders

Patient education is key

Use an interdisciplinary team and multimodal therapies to help treat FM and comorbid depression

Use pharmacologic and non-pharmacologic (especially CBT) strategies

Therapies that may treat both include CBT and antidepressants with analgesic properties

Menu


Following this module, participants will be able to:

Give the prevalence demographics of fibromyalgia (FM)Make a diagnosis of FMOrder appropriate investigations for patients with suspected FMProvide a differential diagnosis for patients presenting with widespread pain, fatigue and sleep problems


Patty is a 32-year-old woman in your practice History:

Under your care for 10 years

Unremarkable past history

Slipped on ice 4 months ago and has had progressive generalized pain and fatigue

Saw a locum 2 weeks ago who ran a battery of tests for multiple symptoms of generalized pain, fatigue and sleep problems

Video 1Video 1

QuestionsQuestions

1. What is the incidence and gender distribution of FM?

2. How do you make the diagnosis of FM?

3. What are the differential diagnoses in this patient?

4. What investigations would you have ordered 2 weeks ago?


Prevalence of FMPrevalence of FM

FM occurs in all ages, both sexes and all cultures, but occurs more frequently in:

Women Patients between the ages of 35–60 years

In Canada:FM affects an estimated 4.9% of adult women and 1.6% of adult men Female-to-male ratio of approximately 3:1

Cardiel et al. Clin Exp Rheumatol. 2002;20:617-624; Carmona et al. Ann Rheum Dis. 2001;60:1040-1045; Lawrence et al. Arthritis Rheum. 1998;41:778-799; Lindell et al. Scand J Prim Health Care. 2000;18:149-153; Neumann et al. Curr Pain Headache Rep. 2003;7:362-368; Prescott et al. Scand J Rheumatol. 1993;22:233-237; White et al. J Rheumatol. 1999; 26:1570-1576; Wolfe F. J Musculoskeletal Pain. 1993;3:137-148; Wolfe et al. Arthritis Rheum. 1995;38:19-28;.











FatigueFatigue







*United States data

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80

100100%

96%

86%

72%

60%56%

52%46%

42% 41%

32%

20%

Muscularpain


Head-aches

Restlesslegs

Numbness and

tingling

Impairedmemory

Leg cramps


Nervous-ness

Major depression


Mood Disorders in FMMood Disorders in FM

At time of diagnosis, approximately 20%-40% of individuals with FM have an identifiable current mood disorder (e.g., depression or anxiety)

Lifetime prevalence of depression: 74%

Lifetime prevalence of anxiety disorder: 60%

In many cases, depression or anxiety may be the result of chronic pain

Arnold et al. Arthritis Rheum. 2004;50:944–952; Boissevain et al. Pain. 1991;45:227-238; Boissevain et al. Pain. 1991;45:239-248; Fishbain et al. Clin J Pain. 1997;13:116–137; Giesecke et al. Arthritis Rheum. 2003;48:2916–2922; Katon et al. Ann Intern Med. 2001;134:917-925.

StressorsStressors

Some triggering event may trigger FM but is not a prerequisite

In many cases, onset of FM is gradual, with no identifiable trigger

Stressors that may trigger FM

Peripheral pain syndromes, physical trauma, infections (e.g., parvovirus, Epstein-Barr virus, Lyme disease, Q fever), psychological stress/distress, including sleep disturbances

The development of FM after a precipitating event may represent the onset of a prolonged and disabling pain syndrome with considerable social and economic implications

Greenfield et al. Arthritis Rheum. 1992;35:678-681.

McLean et al. Med Hypotheses. 2004;63:653-658.

Trigger Factors Associated Factors*

Cold 0 15Stress 9 35Emotions 5 35Overwork 0 22Trauma 24 24Surgery 4 13Death in the family 0 13Family problems 2 25Fatigue 0 23No cause/association 55 5

FM as a Consequence of Trauma

FM as a Consequence of Trauma

Factors Triggering FM or Associated with its Onset (n=136)

In most cases of FM, there is no predisposing trigger.

Adapted from Wolfe F. Am J Med. 1986;81:7-14.

*More than one factor possible for the same patient

Diagnosing FM: Overview

Diagnosing FM: Overview

Patient history of FM or related conditionsPersonal historyFamily history

Physical examinationMost important to rule out other conditions

Differential diagnosisClinical/laboratory evaluation to exclude other conditions such as:

• Osteoarthritis, rheumatoid arthritis, polymyalgia rheumatica (PMR), hypothyroidism, lupus and Sjögren’s syndrome

Note: Extensive lab evaluation is usually not necessary to rule out FM, In some cases, a thyroid-stimulating hormone test may be called for. PMR is usually not a problem as it seldom occurs under the age of 60, whereas the onset of FM after 65 is rare.

Mease. J Rheumatol. 2005;32(suppl 75):6-21; Wolfe et al. Arthritis Rheum. 1990;33:160-172.

Evolution of FM DiagnosisEvolution of FM Diagnosis

Evaluation of tender points

Identification of symptoms complex

New Canadian guidelines being developed

Assessment of FM: American College of Rheumatology (ACR)

Classification Criteria (1990)

Assessment of FM: American College of Rheumatology (ACR)

Classification Criteria (1990)

History of widespread pain that has been present for at least 3 months (ALL of the following should be present):

Pain on both sides of the bodyPain above and below the waistAxial skeletal painPain in at least 11 of 18 tender point sites on digital palpation

Wolf et al. Arthritis Rheum. 1990;33:160-172.

ACR criteria are both sensitive (88.4%) and specific (81.1%)

ACR New Proposed Diagnostic Criteria for FM – 2010 (1)


FM can be diagnosed if:

Symptoms for at least 3 months

No other condition to explain pain

Pain + associated symptoms

Wolfe et al. Arthritis Care Res (Hoboken). 2010;62:600-610.



Associated symptoms include:

Unrefreshed sleep

Cognitive symptoms

Fatigue

Other somatic symptoms

Wolfe et al. Arthritis Care Res (Hoboken). 2010;62:600-610.

SummarySummary

FM is a common disease of middle age with a female-to-male ratio of 3:1Simple investigations and history will exclude other rheumatologic or psychiatric conditionsThe 4 cardinal symptoms of FM include widespread pain, fatigue, sleep disturbance and cognitive slowingThe current diagnosis of FM is based on widespread pain plus associated symptom cluster with a physical exam to exclude other conditions

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Following this module, participants will be able to : Explain the known pathophysiology of fibromyalgia (FM)Provide the natural history of FMNegotiate and explain the diagnosis of FMUse multidisciplinary and other resources to help educate patients around the diagnosis of FM


Patty is a 32-year-old woman in your practiceHistory:

Under your care for 10 yearsUnremarkable past historySlipped on ice 4 months ago and has had progressive generalized pain and fatigueSaw a locum 2 weeks ago who ran a battery of tests for multiple symptoms of generalized pain, fatigue and sleep problemsClinical exam confirms diagnosis of FM

Video 1Video 1

QuestionsQuestions

1. What is FM? How would you explain it to Patty?

2. What is the natural history of FM?

3. Is it better to “label” Patty with the diagnosis of FM?

4. What other strategies could you use to educate Patty about the disease?


Pathogenesis of FM: Overview

Pathogenesis of FM: Overview

FM is a condition of global dysregulation of pain processing Central sensitization is one component

Mechanisms of central sensitization

Excitatory mechanismsExcitatory mechanisms

Inhibitory mechanismsInhibitory mechanisms

Price DD, Staud R. J Rheumatol. 2005;32 (Suppl 75):22-28.

Pathophysiological Changes in FM

Pathophysiological Changes in FM

Increased levels of substance P (>3x) in patients with FM

Functional magnetic resonance imaging (fMRI) studies show a marked regional increase in cerebral blood flow following a painful stimulus in patients with FM compared to controls not suffering FM

Deficit in the endogenous pain inhibitory systems noted in FM patients

Vaerøy et al. Pain. 1988;32:21-26.; Russell et al. Arthritis Rheum. 1994;37:1593-1601. ; Russell et al. In: Russell, ed. Myopain ’95: Abstracts from the 3rd World Congress on Myofascial Pain and Fibromyalgia. San Antonio, Tex; July 30-August 3, 1995.Gracely et al. Arthritis Rheum. 2002;46:1333-1343.; Julien et al. Pain. 2005;114:295-302.

Diagnosis Can Improve Patient Satisfaction

Diagnosis Can Improve Patient Satisfaction

Diagnosis of FM improves health satisfaction

White et al conducted a prospective, community comparison of FM patients in Canada that revealed significantly improved scores 36 months post-diagnosisPatients self-reported health satisfaction on a 5-point Likert scale

Improvement in Patient Health Satisfaction

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4

Baseline Post-diagnosis

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*Statistically significant versus baseline (confidence interval -1.2, -0.4)

Goldenberg et al. JAMA. 2004;292:2388-2395. White et al. Arthritis Rheum. 2002;47:260-265.

Health Economic Consequences Related to the Diagnosis of FM

Health Economic Consequences Related to the Diagnosis of FM

Tests and Imaging Referrals

General Practitioner Visits Drugs

Annemans et al. Arthritis Rheum 2008;58:895-902.

United Kingdom figures

Fate of Patients with FMFate of Patients with FM

Reassure patients that FM is not progressive and that symptoms remain stable over time1

50% were moderately to greatly improved (3 year follow-up)2

• The baseline predictors for a favorable outcome: younger age and less sleep disturbance2

Successful management requires an upbeat, optimistic approach and EARLY initiation of effective, individualized therapy

Therefore, it is important to manage patient’s expectations

1. Kennedy et al. Arthritis Rheum. 1996;39:682-685.2. Fitzcharles et al. J Rheumatol. 2003;30:154-159.

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Some Tips on Providing the DiagnosisSome Tips on Providing the Diagnosis

Be specific about the diagnosis

Be positive about the diagnosis

Promote and encourage patient self-efficacy around the disease but . . .

Set realistic expectations

Emphasize no cure but improved control of symptoms usually possible

Active treatments generally superior to passive treatments

Other Useful Websites/Patient InformationOther Useful Websites/Patient Information

National ME/FM Action Network:http://www.mefmaction.net

Arthritis Society of Canada: www.arthritis.ca Patient workbooks/materials

Starlanyl D, Copeland ME. Fibromyalgia & Chronic Myofascial Pain Syndrome: A Survival Manual. 2nd ed. Oakland, CA : New Harbinger Publications; 2001.Fennell PA. The Chronic Illness Workbook: Strategies And Solutions for Taking Back Your Life. 2nd ed. Latham, NY: Albany Health Management Publishing; 2007. Bested AC, Logan AC. Hope and Help for Chronic Fatigue Syndrome and Fibromyalgia. 2nd ed. Nashville, TN: Cumberland House; 2008.

Local ResourcesLocal Resources

[Facilitators to include list of local FM resources for patients/physicians]

SummarySummary

FM is a neurobiological dysfunctionProviding a positive diagnosis improves health outcomes and reduces costsThe natural history of FM is variable. Significant numbers of patients will improveUse Internet and written resources and other members of a multidisciplinary team to educate patients

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Following this module, participants will be able to:Assess motivation in patients with fibromyalgia (FM)Use simple strategies to increase patients’ readiness to incorporate non-pharmacologic and lifestyleGive evidence-based, non-pharmacologic interventions as treatment for FMRecognize the role of an interdisciplinary team in FM management


Patty is a 32-year-old patient in your practice who was diagnosed with FM that appeared to start after she slipped on some ice. Patty was advised to attend a local “new movement class” targeting de-conditioned patients to increase physical activity. She was also prescribed a medication that would target pain – her most disabling symptom.

Video 1Video 1

QuestionsQuestions

1. What non-pharmacologic interventions have been shown to help with FM?

2. How might you help to motivate Patty?

3. How could your interdisciplinary team (your own team or resources in your community) assist in the management of patients with FM?


Management of FM:Recommended Treatment Approach

Management of FM:Recommended Treatment Approach

Multidisciplinary therapy individualized to patients’ symptoms and presentation is recommended A combination of non-pharmacologic and pharmacologic therapies may benefit most patients

*Limited evidence for efficacy existsBalneotherapy: treatment of disease or health conditions by bathing

Non-pharmacologic

Aerobic exerciseCognitive behavioral therapy (CBT)Patient educationStrength trainingAcupuncture* Biofeedback* Balneotherapy*

Goldenberg et al. JAMA. 2004;292:2388-2395.

Non-pharmacologic Treatments with Demonstrated Efficacy Currently in Use

Non-pharmacologic Treatments with Demonstrated Efficacy Currently in Use

CBTPositive effects on coping with and control over pain

• Not proven to improve pain Proven to improve physical functionShould be done by a trained professional

Aerobic and strengthening exercisesReduce pain, increase self-efficacy, improve quality of life and reduce depression Aerobic exercise should be of low-to-moderate intensity, 2–5 times/week

Patient educationConflicting evidence but some studies have shown improvements in pain, sleep, fatigue and quality of life

Goldenberg et al. JAMA. 2004;292:2388-2395.Brosseau L, et al. Phys Ther. 2008;88:857-71. Brosseau L, et al. Phys Ther. 2008;88:873-86.

Alternative/Chiropractic treatments for FM

Alternative/Chiropractic treatments for FM

Strong evidence supports aerobic exercise and CBT

Moderate evidence supports massage, muscle strength training, acupuncture and spa therapy (balneotherapy)

Limited evidence supports spinal manipulation, movement/body awareness, vitamins, herbs and dietary modification

Schneider et al. J Manipulative Physiol Ther. 2009;32:25-40.

Useful Websites/Patient InformationUseful Websites/Patient Information

National ME/FM Action Network:http://www.mefmaction.net

Arthritis Society of Canada: www.arthritis.ca Patient workbooks/materials:

Starlanyl D, Copeland ME. Fibromyalgia & Chronic Myofascial Pain Syndrome: A Survival Manual. 2nd ed. Oakland, CA : New Harbinger Publications; 2001.Fennell PA. The Chronic Illness Workbook: Strategies And Solutions for Taking Back Your Life. 2nd ed. Latham, NY: Albany Health Management Publishing; 2007. Bested AC, Logan AC. Hope and Help for Chronic Fatigue Syndrome and Fibromyalgia. 2nd ed. Nashville, TN: Cumberland House; 2008.

Local resources

Helping patients embrace lifestyle choices — improving self-efficacyHelping patients embrace lifestyle choices — improving self-efficacy

Conviction and Confidence:A Model for Successful Interventions

Conviction and Confidence:A Model for Successful Interventions

Patient conviction (i.e., sense of the patient’s personal, emotional recognition of the benefits of changing a behaviour)

“Is increasing your physical activity a priority for you?”

Patient confidence (i.e., sense of the patient’s ability to modify a behaviour)

“If you did decide to become physically active, how confident are you that you would be able to follow though?”

Keller VF, White KM. J Clin Outcomes Manage. 1997;4:33-36.Miller WR, Rollnick S. Motivational interviewing. New York NY: Guilford Press; 1991.

LACK OF KNOWLEDGE

CYNICISM

FRUSTRATION

SKEPTICISM

C O N F I D E N C E

C O

N V

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SUCCESS

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(Barriers)

Conviction – Confidence ModelConviction – Confidence Model10

Adapted from Keller VF, White KM. J Clin Outcomes Manage. 1997;4:33-36.; Miller WR, Rollnick S. Motivational interviewing. New York NY: Guilford Press; 1991.

How to Increase Conviction How to Increase Conviction

Get patients to articulate benefits of change

Get patients to articulate benefits of change

How to Increase Confidence How to Increase Confidence

Identify barriers to change and help patients overcome those barriers by identifying their own solutions

Identify barriers to change and help patients overcome those barriers by identifying their own solutions

A Model for Successful Interventions

A Model for Successful Interventions

Keller VF, White KM. J Clin Outcomes Manage. 1997;4:33-36.; Miller WR, Rollnick S. Motivational interviewing. New York NY: Guilford Press; 1991.

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Confidence

Powerless (Barriers) Unwavering10

Pre-contemplation

Contemplation

Preparation Empowered

Skepticism

Lack of knowledge

Cynicism

Frustration

Success

Action

PattyPatty

Video 2Video 2

SummarySummary

Non-pharmacologic therapies are an important first-line treatment for patients with FMCompliance to lifestyle interventions can be increased by assessing and intervening with motivational interviewing techniquesThe use of multidisciplinary resources can improve outcomes and facilitate time-efficient treatment

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Following this module, participants will be able to: Link the medications useful in treatment of fibromyalgia (FM)Match medication properties and side effects with therapeutic targets for patients with FMArticulate safety issues with medications commonly used to treat FM


Patty is a 32-year-old patient in your practice who was diagnosed with FM that appeared to start after she slipped on some ice. She presented with a typical symptom complex: generalized pain, fatigue, non-restorative broken sleep and mental fogging. You asked her after the first visit to review medication options with a pharmacist who works as part of your interdisciplinary team.

ExerciseComplete the worksheet with your partner

ExerciseComplete the worksheet with your partner

For each class of medication, indicate what is the effect of each symptom, using -, +, ++ or +++, and describe the most common side effects.

*Medication with official indication in fibromyalgia

Class Medications Overall FM

Pain Fatigue Sleep Depression/ anxiety

Most common side effects seen in patients, based on your experience

Antiepilepticanalgesics

Pregabalin*

Gabapentin

Atypical antidepressants Bupropion

Atypical antipsychotics

Benzodiazepines

Cannabinoids

Dopamine agonist Pramipexole

Dopamine NE Modafinil

Muscle relaxant (NE) Cyclobenzaprine

NSAIDs

Opioids

Opioid agonist SNRI Tramadol

Psycho-stimulants Dextroamphetamine, methylphenidate

SNRI Duloxetine*Venlafaxine

SSRI Sertraline

TCA Amitriptyline(desipramine, doxepin, nortriptyline)

Zopiclone

Video 1Video 1

Medical Management of FM: Considerations

Medical Management of FM: Considerations

Don’t set unrealistic goals; target functional improvementImportant to manage patient’s expectationsKeep the patient involved in treatment decisionsBalance efficacy with side effectsAvoid rapid dose escalation: start low, go slow!

Medical Management of FM: Considerations (cont’d)

Medical Management of FM: Considerations (cont’d)

Use opioids with caution; keep doses low

Refer to the new Canadian practice guideline on use of chronic opioid therapy for non-cancer pain

Always augment with non-medical therapy

Polypharmacy may be necessary, but keep doses low and be mindful of side effects and function

PolypharmacyPolypharmacy

Often necessary for symptom control

May exacerbate or cause some of the target symptoms of FM (cognitive impairment, sleep disturbance, fatigue)

Be aware of drug interactions (e.g., serotonin syndrome)

Best Evidence: Medication Options in FM

Best Evidence: Medication Options in FM


Efficacy in Overall FM Management

Effect on Major Symptoms

Off/On-Label Indication

Amitriptyline(desipramine, doxepin, nortriptyline)

TCA(NE > 5HT)

+ Pain, sleep, anxiety(poor long term)

Off

Duloxetine SNRI +++ Pain, depression, anxiety

On


++ Pain, sleep, anxiety

Off


+++ Pain, sleep, anxiety

On

Tramadol Opioid agonistSNRI

++ Pain Off

GABA, γ-aminobutyric acid; NE, norepinephrine; SNRI, serotonin-norepinephrine reuptake inhibitor; TCA, tricyclic antidepressant



Some Evidence: Medication Options in FM

Some Evidence: Medication Options in FM



Effect on Major Symptoms

Off/on-Label Indication

Comments

Atypical antipsychotics

Dopamine ± Sleep Off Open label study


+ Sleep Off Lack of effectiveness in FM pain

Cyclobenza-prine

Muscle relaxant (NE)

+ Pain, sleep(poor long term)

Off


+ Pain, fatigue Off Limited population studied

Sertraline SSRI ± Pain, depression

Off Compared versus physical therapy

Venlafaxine SNRI > SSRI + Pain, depression, anxiety

Off Limited FM study

+++: strong evidence for use/efficacy; ++: moderate evidence use/efficacy; +: some evidence use/efficacy; -: no evidence for use/efficacySSRI, selective serotonin reuptake inhibitor


No Evidence: Medication Options in FM

No Evidence: Medication Options in FM


Rationale for Use

Concern for Use

Benzodiazepines GABA increase Anxiety AddictionSide effects

NSAIDs Prostaglandin inhibition

Analgesia NSAID-related side effects

Opioids Opioid receptor agonists

Analgesia AddictionSide effects

Stimulants(dextroamphetamine, methylphenidate)

NEDopamine

Fatigue DiversionAbuse

Zopiclone GABA Sleep

NSAID, non-steroidal anti-inflammatory drug



Video 2Video 2

SummarySummary

Establish realistic treatment goals

Important to manage patient expectations

Chose medications that target the most troublesome symptoms

Start low, go slow – reassure

Use polypharmacy with care

Opioids are controversial

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Following this module, participants will be able to: Differentiate the concepts of functional remission versus full symptom remissionEstablish realistic therapeutic goals with patientsUse interdisciplinary team resources to manage patients with fibromyalgia (FM)


Patty is a 32-year-old patient in your practice who was diagnosed with FM that appeared to start after she slipped on some ice. After communicating the diagnosis to her, you referred her to a local FM lifestyle program. She was also started on a medication targeting sleep restoration, her most debilitating symptom at presentation. She presents for a follow-up visit.

Video 1Video 1

QuestionsQuestions

1. How do you monitor the effectiveness of treatments?

2. What is the realistic endpoint of therapy for FM? Is full remission of symptoms a reasonable goal?

3. How do you explain or negotiate therapeutic goals to patients?

4. How could you use an interdisciplinary team (your own team or resources in your community) to manage your patients with FM?


Monitoring TreatmentMonitoring Treatment

Currently, there is no currently validated acceptable tool for assessing response to treatment Consider evaluation of patients with FM in these dimensions:

Pain FatigueSleepFunctionality (physical and psychological)Mood

Functional versus Symptom Remission Functional versus Symptom Remission

Symptomatic remission is resolution of all symptoms associated with the condition

Functional remission is improvement of symptoms to the point where patients can maximize function (vocational, interpersonal, social)

Although most patients with FM will not attain full symptom remission in the short term, the natural history of FM is more positive

Fate of Patients with FMFate of Patients with FM

Reassure patients that FM is not progressive and that symptoms remain stable over time1

50% were moderately to greatly improved (3 year follow-up)2

• The baseline predictors for a favorable outcome: younger age and less sleep disturbance2

Successful management requires an upbeat, optimistic approach and EARLY initiation of effective, individualized therapy

1. Kennedy et al. Arthritis Rheum. 1996;39:682-685.2. Fitzcharles et al. J Rheumatol. 2003;30:154-159.

Strategy for ManagementStrategy for Management

Explain the long-term nature of FMReassure the patient that it is not life-threatening Choose therapies that target the most disabling symptom(s)Emphasize functional improvements Balance medication side effects with improvement in function

Medications Options for FM (1) Medications Options for FM (1)



Effect on major symptoms


Comments

Amitriptyline(desipramine, nortriptyline, doxepin)

TCA(NE > 5HT)

+ Pain, sleep, anxiety

Off FM dose < usual antidepressant dosePoor long term


+ Sleep Off Lack of effectiveness in FM pain

Cyclobenzaprine Muscle relaxant (NE)

+ Pain, sleep Off Poor long term

Duloxetine SNRI +++ Pain, depression, anxiety

On

+++: strong evidence for use/efficacy; ++: moderate evidence use/efficacy; +: some evidence use/efficacy; -: no evidence for use/efficacyNE, norepinephrine; SNRI, serotonin-norepinephrine reuptake inhibitor; TCA, tricyclic antidepressant


Medications Options For FM (2) Medications Options For FM (2)



Effect on major symptoms


Comments


++ Pain, sleep, anxiety

Off

Modafinil DopamineNE

+ Fatigue Off Open label small study

Pramipexole Dopamine agonist + Pain, fatigue Off Limited population studied


+++ Pain, sleep, anxiety

On

Sertraline SSRI ++ Pain, depression Off Compared versus physical therapy

Tramadol Opioid agonistSNRI

++ Pain Off

Venlafaxine SNRI > SSRI + Pain, depression, anxiety

Off Limited FM study

+++: strong evidence for use/efficacy; ++: moderate evidence use/efficacy; +: some evidence use/efficacy; -: no evidence for use/efficacySSRI, selective serotonin reuptake inhibitor


Video 2Video 2

SummarySummary

It is rare that treatment will result in full symptom remissionFocus for therapy is to increase the level of function, accepting some degree of residual symptomsEducate patients around realistic treatment goalsWhere possible, quantify symptoms and level of functionAn interdisciplinary team can assist in education, establishing and reinforcing treatment goalsFor pharmacologic treatment: start low, go slow!

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Disclosure This program was developed from an educational grant from Pfizer to the University of...

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Transcript of Disclosure This program was developed from an educational grant from Pfizer to the University of...