Fibromyalgia: not as hard as it looksA.S.A. OCFP November 2013

Ruth Dubin MD PhD CCFP FCFPDAAPM DCAPM

National Fibromyalgia Guideline Advisory Committee

Chair CFPC Chronic Pain Committee

Faculty/Presenter Disclosure

• Faculty: Ruth Dubin

• Relationships with commercial interests:– Grants/Research Support: not applicable – Speakers Bureau/Honoraria: not applicable– Consulting Fees: None– Other: None

CFPC CoI Templates: Slide 1

Disclosure of Commercial Support• This program has received financial support from no one in the form of • This program has received in-kind support from no one in the form of

• Potential for conflict(s) of interest: NOT APPLICABLE– [Speaker/Faculty name] has received [payment/funding, etc.] from

[organization supporting this program AND/OR organization whose product(s) are being discussed in this program].

– [Supporting organization name] [developed/licenses/distributes/benefits from the sale of, etc.] a product that will be discussed in this program: [insert generic and brand name here].

CFPC CoI Templates: Slide 2

Mitigating Potential Bias

• Content on pharmaceuticals is minimal• Any discussion of off-label use of medications is based on

recommendations made by the Canadian Fibromyalgia Guideline

CFPC CoI Templates: Slide 3

Faculty/Presenter DisclosureFaculty/Presenter Disclosure

• Faculty: Ian Shiozaki• Program: 51st Annual Scientific Assembly

• Relationships with commercial interests:– speaker : GSK, Pfizer, AstraZeneca, Merck, Abbott, Bayer, Eli Lilly,

Roche, Novartis Boehringer

– Advisory board: BMS, Lundbeck, AstraZeneca, Pfizer, Eli Lilly, 

Disclosure of Commercial Disclosure of Commercial SupportSupport

• This program has received financial support N/A• This program has received in-kind support from N/a

• Potential for conflict(s) of interest:– N/A

Mitigating Potential BiasMitigating Potential Bias

• N/A

True or False?

• Fibromyalgia is a diagnosis of exclusion. T/F

• Rheumatology referrals and/or extensive testing are required before one can make a definitive diagnosis of FMA. T/F

• I don’t have the time or skills to deal with Fibromyalgia patients. T/F

2012 Canadian Fibromyalgia Guidelines

Executive Committee

Dr. Mary-Ann Fitzcharles, Peter A. Ste-Marie, Dr. Don L. Goldenberg, Dr. John X. Pereira, Dr. Susan Abbey,

Dr. Manon Choinière, Dr. Gordon Ko, Dr. Dwight Moulin, Dr. Pantelis Panopalis, Johanne Proulx, Dr. Yoram Shir

*Fitzcharles at al 2013. CMAJ. May 15, 2013 DOI 10.1503/cmaj.121414

*Fitzcharles et al 2013. Pain Res. Manage. 18(3):119-126

NOT ANOTHER GUIDELINE!!!

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Three new concepts…

• FM patients are best managed in primary care setting

• Multimodal treatments ideal, with only modest effect of drugs

• Maintain function and remain in workforce

MEDICINEMedications &

Interventions

MOVEMENTPhysical / Rehabilitative

MINDPsychologicalAnd Sleep

SELF MANAGEMENTSELF MANAGEMENT

*(R Jovey, Canadian Pain Society,2009-with input from R.Dubin)*(R Jovey, Canadian Pain Society,2009-with input from R.Dubin)Also see: Action Plan for the organization and delivery of chronic pain services in Nova Scotia, 2006Also see: Action Plan for the organization and delivery of chronic pain services in Nova Scotia, 2006

The ideal treatment of CNCP*

Why develop Guidelines?

• Recent guidelines ±10 years old• Advances in understanding FM

– Neurophysiologic– Treatments

• New diagnostic criteria (ACR 2010)*• Call for guidance & direction

– Requested by Canadian Pain Society*Wolfe at al. 2010. Arthritis Care and Research 62(5):600

The care gap…

• Prevalence of FM……2%• Delay in diagnosis…..5 yrs

• ↓ ↓ health care use after diagnosishealth care use after diagnosis• Improved health after diagnosisImproved health after diagnosis

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Guidelines address three broad concepts in 46 recommendations

• Diagnosis and evaluation 12• Management 23• Patient trajectory and follow-up 11

new clinical concepts regarding FM have been incorporated into these guidelines.

The guide…diagnosis

DO NOT USE CRITERIA TO DIAGNOSE AN INDIVIDUAL PATIENTDO NOT USE CRITERIA TO DIAGNOSE AN INDIVIDUAL PATIENT

• FM is a clinical construct• Pain is the pivot + sleep problems, fatigue, cognitive changes etc

– 2/3 pain, 1/3 other• Patient must be examined

– To exclude other physical abnormality– Tender points not needed

• Simple blood testing only

FiRST Questionnaire

Sensitivity: 90.5% Specificity 85.7%Perrot S et al Pain 150 (2010) 250-256FiRST © Serge Perrot, Didier Bouhassira, REDAR, 2010. All rights reserved.

Development of Chronic Widespread Pain over a 12 year period

Stefan Bergman1

1R&D-centre, Spenshult hospital, Oskarström, Sweden

Conclusions

Subjects move to and from chronic widespread pain (CWP) over time.

Predictive factors differ between subjects with no chronic pain (NCP) at baseline that develop CWP, and subjects that improves from CWP to NCP over a twelve year period.

The results suggest different pathogenesis in the two ends of the pain spectrum.Background

Chronic widespread pain (CWP) is often regarded as one end in a spectrum of more or less extensive pain distribution in the body. We have previously reported that subjects move to and from CWP over a three year period.

The aim of the study was to describe the multifactorial process of pain development over a 12 year period.Method

A baseline postal survey to 2425 subjects from the general population aged 20-74. Localisation of pain was reported by a drawing of the body. Subjects were classified as having no chronic pain (NCP; n=1466), chronic regional pain (CRP; n=588), or CWP (n=303). 68 subjects could not be classified. Pain development was followed over 12 years. The predictive values of baseline background factors (age, sex, education, smoking, alcohol consumption, immigrant, sleep structure) were analysed by multivariate logistic regression.

Results

1582 subjects (65%) responded at the 12 year follow up. Out of 959 subjects that had reported NCP at baseline, 66 (7%) reported CWP at follow up. Out of 192 subjects that had reported CWP at baseline, 35 (18%) reported NCP at follow up.

The development of CWP from NCP over 12 years was predicted by: -being aged 34-46 OR 2.5; 95% CI 1.2-5.4- low educational level OR 3.0; 95% CI 1.6-5.6- being an immigrant OR 2.4; 95% CI 1.1-5.1 - problems falling asleep OR 8.2; 95% CI 3.0-22.1

The improvement to NCP from CWP over 12 years was predicted by:- never being a smoker OR 3.8; 95% CI 1.4-10.0 - drinking alcohol weekly OR 3.5; 95% CI 1.1-11.4 - no nightly awakenings OR 4.5; 95% CI 1.1-17.9 NCP CRP CWP

stefan.bergman@spenshult.se www.fou-spenshult.se

From Ceko M, Fitzcharles M. and P Ste-MarieA descriptive analysis of theBody Map in patients withFibromyalgia

Canadian Pain Society 2012

No tender points does not mean you do not examine patient

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Pic TP

Seek and Ye Shall Find:

HI TECH TOOLS:• Cotton balls• Safety pin• Paper clip• Brush• Tuning fork• Warm and cold water• Your hands

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What conditions not to miss?

• Endocrine • thyroid, parathyroid

• Neurological• MSMS, myasthenia gravis, neuropathy

• MSK disease• early inflammatory arthritis, SLE, myositis, PMR,PMR,

hypermobility• Psychiatric

• DepressionDepression, borderline personality, drug seekingdrug seeking, somatization

• Drugs• statins,statins, aromatase inhibitors, PPI’s, bisphosphonates,

chemotherapy

Fibromyalgia?• 48 y.o. female• Referred with diagnosis of

FMA, lots of psychosocial stress

• History of AM stiffness• Sometimes so bad she

had to crawl up the stairs• No allodynia, no typical

tender points• History of iritis• Tender over her joints, no

swelling etcl

The guide…diagnosis cont.

• As early as possible (level 5)• Primary care is ideal setting (level 1) : early Primary care is ideal setting (level 1) : early

diagnosis reduces disease-related anxiety (major diagnosis reduces disease-related anxiety (major driver of healthcare utilization: THERE MUST BE driver of healthcare utilization: THERE MUST BE SOMETHING TERRIBLY WRONG WITH ME!)SOMETHING TERRIBLY WRONG WITH ME!)– Specialist referral only if (level 5)

• Atypical symptoms• Difficulties in management• eg. sleep specialist, psychologist

The guide…diagnosis cont.

• Access to team member for support (level 3)• Healthcare professionals

– knowledgeable (level 5)– Empathetic, shared decision-making (level 3)

• Contributing factors such as genetics or triggering events must not hinder care(level 5)

• ACR 2010 criteria (level 3)– May validate clinical diagnosis

Treatment objectives

Think…………….Think…………….

• symptom based treatments

• mechanisms based treatments

– Improve• symptoms• function

Do no harmDo no harm

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The guide…management key points

• No ideal treatment• Patient tailored approach (level 5)

– Symptom-based management– Non-pharmacologic & pharmacologic strategies

• Aim to – symptoms– Maintain / improve function

The guide…management key points

• Self-management strategies are imperative (level 1)

• Internal locus of control– Patient active participant!! (level 1)– Multimodal approach (level 1)– Realistic goals, coping strategies (level 5)– Pacing, but continue normal life (level 4)

The guide….non pharma treatments

• Exercise (level 1)– Best available evidence – Any type

• aerobics, water based, stretching, etc.

• CAM – Insufficient evidence (level 1)– Encourage disclosure of use (level 5)

WHAT IS SELF MANAGEMENT?

“ The individual’s ability to manage the symptoms, treatment, physical and social

consequences and lifestyle changes inherent in living with a chronic condition”

Barlow 2002

Chronic Pain Self-Management*

* SLIDE CONTENT COURTESY OF DR SANDRA LEFORT, MEMORIAL UNIVERSITY

• Based on the Stanford Chronic Disease Self-Management Program (K Lorig)

• Active is better than passive• Keep Wellness in the foreground (no more PAIN

DIARIES!) • The patient is the “expert” who works in

partnership with their HCP• The patient takes responsibility for their own

health, uses their mind for pain management, uses pacing, problem-solving, action plans and goal-setting

http://patienteducation.stanford.edu/programs/cpsmp.html

• Develop nonjudgmental awareness of moment-to-moment experience within a context of openness, kindness, tolerance and acceptance of perceptible sensory, mental and emotional phenomena.

• Can improve coping and health-related quality of life in many chronic conditions including chronic pain.

*Pain. 152 2011:361-369

Systematic Review of MBSR in FMA, IBS, Lakhan and Schofield PLoS One 2013Aug 26 (8)

Fortney et al. 2013 Ann Fam Med 11(5):412

MOVEMENT IS KEY

• Tai Chi Wang et al. NEJM 2010: 363 (8): 744

• Qi Gong (Mindful Movement/Meditative Exercise) Sawynok et al. Evidence Based Complementary and

Alternative Medicine. 2013.

• Aerobics and Water exercise Mannerkorpi and Henriksen. 2007. Best Practise and Clin. Research Rheumatology. 21:513

• Yoga Carson et al. 2010. Pain 151: 530

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The guide…. pharma treatments

• No perfect drug• Lowest dose, gradual increase (level 5)• Expect only a modest response• Consider combination drugs (level 5)• Be knowledgeable regarding drug mechanisms

(level 5)• Constant evaluation re risk vs. benefit (level 5)

Cautions re pharmacologic treatments

• Change 1 thing at a time

• Side effects often similar to symptoms of FM

• Caution re dependency on pills which fosters “passivity”

Symptom based management• Pain

– Analgesics (simple, mild NSAIDs, weak opioids)– Anticonvulsants (gabapentinoids)– Antidepressant group– Opioids– ??? Dopamine agonists

• Sleep– Gabapentinoids– TCA’s– Benzodiazepines– Cannabinoids,– Atypical agents…quietapine, trazadone, sodium oxybate

• Mood – Your best choice taking pt individual characteristics

• Fatigue– Bupropion, methylphenidate, modafinil

The art of FM pharmacotherapy

• Patient tailored treatment• Pain, fatigue & mood+++….SNRI• Pain & sleep++++…..anticonvulsant• TCA’s still have a place

• LOW, LOW doses of drugs

The guide…. pharma treatments cont.

• WHO step-up analgesic ladder (level 5)• NSAIDS – low dose, short use (level 5)• Tramadol – moderate/severe pain (level 2)• Strong opioids – discouraged (level 5)• Cannabinoid (pharma) – sleep (level 3)

Patients choice of medications

• Internet survey ..2500 FM patients USA• Most common medications

– Acetaminophen, ibuprofen, naproxen, cyclobenzaprine, amitriptyline, ASA

• Perceived as best– hydrocodone, aprazolam, oxycodone, zolpidem,

cyclobenzaprine, and clonazepam.

Pharmacologic treatments ….mechanism based

• Anticonvulsants– Gabapentinoids sensitization

• Antidepressants– norepinephrine– serotonin– dopamine

• ? Dopamine central

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descending inhibition

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Mechanism based: descending pathwaysMechanism based: descending pathways

serotonin norepinephrine opioids cannabinoids

The guide…. pharma treatments cont.

• Anticonvulsants– Explain mechanism to patient (level 5)– Low dose (level 1)

• Antidepressants– Explain mechanism to patient (level 5)– TCAs, SSRIs & SNRIs can be used (level 1)– Choice – MD knowledge, Pt characteristics (level 5)

How low can you go?

• Amitriptyline: 10mg at bedtime• Duloxetine: 30mg in am with food*• Pregabalin: 25-50mg with supper*• Gabapentin: 100mg with supper

Consider polypharmacy (but no evidence)*I start even lower

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Antidepressants effects in FM similar to that in low back pain

Standardized Mean Difference in Pain Improvement

Salerno SM, et al. Arch Intern Med. 2002;162:19-24.

Jenkins, et al. 1976 (imipramine)

Alcoff, et al. 1982 (imipramine)

Hameroff, et al. 1984 (doxepin)

Ward, et al. 1984 (desipramine/doxepin)

Pheasant, et al. 1983 (amitriptyline)

Goodkin, et al. 1990 (trazodone)

Atkinson, et al. 1998 (nortriptyline)

Atkinson, et al. 1999 (maprotiline)

Atkinson, et al. 1999 (paroxetine)

Dickins, et al. 2000 (paroxetine)

0.41 (0.22-0.61)Overall (95% CI)

-1.6 1.6

Standardized Mean Difference

0

Favors TreatmentFavors Placebo

Sleep and Fatigue

• Sleep: many have restless legspramiprexole (small studies: pathological gambling)

• Fatigue: exercise, activity, pacing

• ??? Stimulants

The guide…patient trajectory

• Follow-up time interval depends on MD judgment (level 5)

• New symptoms– Evaluate using clinical judgment (level 5)

• FM symptoms persist, wax and wane (level 3)• No value to dwell on past lifetime events, move

forward (level 5)• Empathetic and supportive relationship with PCP

is extremely important!

The guide…patient trajectory cont.

• Poor outcome when (level 5)– Passive patient– External locus of control– Untreated prominent mood disorder

• Outcome tools– Patient Global Impression of Change (level 3)– Goal attainment (level 5)– Do not use tender points for outcome (level 3)

The guide…work and cost

• Retention in workforce encouraged (level 3)• Rehab program if necessary (level 5)• Reduce costs by treating depression (level 3)

When do things go wrong?• MD

– Wrong diagnosis– Not attending to mood, sleep– Over treating….pills, investigations

• Patient– No goals, wants magic pill, unrealistic expectations– The passive, negative patient– Secondary gain

• Financial• Social support• Psychological support

Key points…• FMA is a condition resulting from maladaptive

neuroplasticity– Primary setting is recommended– Do not over medicalize patient

• Non-pharma strategies very important– Patient self management

• Symptom-based management– No ideal drug– Drugs show modest effects only

• Encourage retention in workforce• Relationship with a supportive PCP is crucial

True or False?

• Fibromyalgia is a diagnosis of exclusion. T/F

• Rheumatology referrals and/or extensive testing are required before one can make a definitive diagnosis of FMA. T/F

• I don’t have the time or skills to deal with Fibromyalgia patients. T/F

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