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MANAGEMENT OF FIBROMYALGIC
       SYNDROME
     Prof. A.V. SRINIVASAN
      M.D,D.M,PhD,DSc,FIAN,FAAN
     Emeritus Professor – The Tamil Nadu
         Dr. MGR Medical University
OUTLINE
What is Fibromyalgia (FMS)?
What causes it?
Who gets it?
How is it diagnosed?
How is it treated?
What are some of the common misconceptions
about the syndrome?
What is Fibromyalgia (FMS)?
A clinical syndrome characterized by
widespread muscular pain (usually
chronic),
fatigue and
muscle tenderness (tender points)
What is FMS? (cont.)
    Additional symptoms are common and include:
- poor sleep almost always
- headaches
- irritable bowel syndrome
- cognitive and memory problems
              “fibro fog”
- numbness and tingling in fingers and toes
What is FMS? (cont.)
- irritable bladder
- temporomandibular joint (TMJ) disorder
- restless leg syndrome
- dry eyes and dry mouth
- morning stiffness
- anxiety and depression

Symptoms including pain may wax and wane over
  time
FMS Symptom Complex

               Pain, fatigue, & sleep disturbance are
                  present in at least 86% patients




ACR Fibromyalgia Diagnostic Criteria. National Fibromyalgia Research Association Web site. Available at:
http://www.nfra.net/Diagnost.htm. Accessed October 18, 2007.
What causes FMS?
Cause is unknown
Abnormally high levels of Substance P in spinal
fluid in some patients
Substance P important in transmission and
amplification of pain signals to and from brain
“Volume control” is turned up too high in brain’s
pain centers
What causes FMS? (cont)
Familial tendency to develop FMS suggests
genetic role
Can be triggered by physical, emotional or
environmental stressors such as car accidents,
repetitive injuries and certain diseases
Patients with Rheumatoid arthritis and SLE
(Lupus) are more likely to develop FMS
What causes FMS? (cont.)
Other conditions such as Lyme disease and
obstructive sleep apnea (OSA) have been
associated with FMS
Sleep deprivation with disruption of delta-wave
sleep (non-REM stage IV) is associated with
day-time fatigue and
fibromyalgia syndrome
Who gets FMS?
Affects as many as 1 in 50 Americans
Most common in middle-aged women
Men and children may also develop the disorder
Patients with RA, SLE and Ankylosing
spondylitis are more likely
Women who have a family member with FMS
are more likely to develop it
How is FMS diagnosed?
A diagnosis is made by evaluation of symptoms
and presence of tender points
American College of Rheumatology
Classification Criteria for Fibromyalgia (1990)
…….widespread pain for at least 3 months and
pain in 11 out of 18 tender point sites on digital
palpation
ACR classification criteria:
      fibromyalgia
Both criteria must be satisfied
 – History of widespread pain for more than 3 months, on
   both sides of the body, above and below the waist, and
   axial skeleton (cervical spine, anterior chest, thoracic
   pain, or low back)

 – Pain in 11 of 18 tender point sites on digital palpation with
   approximate force of 4 kg.

Presence of second clinical disorder does not exclude
diagnosis of fibromyalgia.
ACR Diagnostic Criteria for FMS
     History of widespread pain for at least 3 months
      – Pain on both sides of the body PLUS
      – Pain above and below the waist PLUS
      – Axial skeletal pain
     Pain in at least 11 of 18 tender-point sites on digital
     palpation
      – Thumb Pressure is Applied to 18 tender-point sites
      – Until Nail Bed is Starting to Blanch (~ 4 kg of pressure)




Wolf et al. Arthritis Rheum. 1990;33:160-172.
Fibromyalgia: tender points
        (diagram)
How is FMS diagnosed? (cont.)
X-rays, blood tests, specialized scans such as
nuclear medicine and CT, muscle biopsies are
all normal
Objective “markers of inflammation” such as
ESR (erythrocyte sedimentation rate) are normal
Must be distinguished from other common
diffuse pain conditions such as RA, SLE,
Hypothyroidism and Polymyalgia Rheumatica
(PMR)
How is FMS treated?

Fibromyalgia is a chronic condition managed
with both medications and physical modalities

Medication therapy is largely symptomatic, as
there is no definitive treatment cure for
fibromyalgia
General Recommendations
Fibromyalgia should be recognized as a heterogeneous
condition comprising of a range of symptoms & features
 – Effective management should take into account all
   these factors
Optimal treatment therefore requires a multidisciplinary
approach with
 – Combination of non-pharmacological and
   pharmacological treatment modalities
 – Tailored according to pain intensity, sleep disturbance,
   fatigue & other symptoms, and function
 – Associated co-morbidities
 – In discussion with the patient
Available Treatment Modalities




Mease P. J Rheumatol. 2005; 32 (suppl 75): 6.
Carville, et al. Ann Rheum Dis. Doi:10.1136/ard.2007.071522.
Goldenberg et al. JAMA. 2004; 292: 2388.
Clauw DJ, Crofford LJ. Best Pract Res Clin Rheumatol. 2003; 17: 685.
Arnold LM, et al. Arthritis Rheum. 2007;56:1336-1344.
Pharmacological Modalities
              Short-Term Long-Term
Drugs         Efficacy   Efficacy  Safety/ Tolerability
Amitriptyline Multiple   -         Anti-cholinergic, anti-
              small RCTs           adrenergic, anti-
                                   histaminic, cardiac muscle
                                   suppressant effects
Duloxetine   2 RCTs      1 RCT       Insomnia, GI & CV effects
                         (Pain)
Gabapentin   1 RCT       -           Dizziness, somnolence,
                                     weight gain
Pregabalin   4 RCTs      1 RCT (pain Dizziness, somnolence,
                         & function) weight gain
Tramadol     1 RCT       -           Dizziness, somnolence,
                                     headache, GI effects
Stepwise Treatment of
                                                  Fibromyalgia
                                                                                                     Confirm diagnosis


                                                                Identify important symptom domains, their severity,
                                                                            and level of patient function


                                                                      Evaluate for comorbid medical and psychiatric
                                                                                       disorders


                                                                     Assess psychosocial stressors, level of fitness,
                                                                               and barriers to treatment


                                                                               Provide education about fibromyalgia


                                                                                            Review treatment options



Arnold LM. Arthritis Res Ther. 2006;8:212. Available online: http://arthritis-research.com/content/8/4/212.
Accessed February 28, 2007.
Stepwise Treatment of
                                               Fibromyalgia (cont’d)
                                                           As a first-line approach for patients with moderate to
                                                            severe pain, trial with evidence-based medications


                                                          Provide additional treatment for comorbid conditions


                                                     Adjunctive CBT for patients with prominent psychosocial
                                                        stressors, and/or difficulty coping, and/or difficulty
                                                                            functioning


                                                                                   Encourage exercise according to
                                                                                            fitness level




Arnold LM. Arthritis Res Ther. 2006;8:212. Available online: http://arthritis-research.com/content/8/4/212.
Accessed February 28, 2007.
How is FMS treated? (cont.)
  Current studies suggest that the best
  pharmacologic treatment for treating pain and
  improving sleep disturbance includes:
- Tricyclic compounds such as cyclobenzaprine
  (FLEXERIL) and amitriptyline (ELAVIL)
- Dual reuptake inhibitors such as venlafaxine
  (EFFEXOR), duloxetine (CYMBALTA) and
  tramadol (ULTRAM)
- SSRIs/ antidepressants such as fluoxetine
  (PROZAC), paroxetine (PAXIL) and
  sertraline (ZOLOFT) for depression and
  pain
- Recent studies have shown that the anti-
  epileptics (seizure meds) gabapentin
  (NEURONTIN) and pregabalin (LYRICA)
  have been effective
- NSAIDs (non-steroidal anti-inflammatory drugs) such as
  ibuprofen and naproxen are generally ineffective

- Long acting opioids (narcotics) generally are not of great
  benefit either

- Benzodiazepines such as diazepam (VALIUM) and
  clonazepam (KLONIPIN) may be useful for patients with
  restless leg syndrome or very severe sleep disturbance
  who have not responded to other therapies
Other Therapies for FMS
 Complementary and alternative therapies have
 been used although not well studied in FMS

- Therapeutic massage
- Myofascial release therapy
- Acupuncture
Other Therapies for FMS
  Patient Self-Management
- Schedule time to relax, including deep breathing
  and meditation
- Establish routine for going to bed and waking up
- Aerobic exercise on regular basis
- Self-education i.e. Arthritis Foundation,
                 National Fibromyalgia Assn.
- Support group
- Cognitive Behavioral Therapy (CBT)
Common Misconceptions
Eleven (11) out of 18 tender points needed to
  make the diagnosis of FMS
      (2005 ACR Classification Criteria)

               FALSE

Tenderness can be widespread without tender
  points
The major symptom in FMS is pain

              FALSE

A variety of neurologic abnormalities may
 be described including numbness and
 tingling of the extremities, cognitive and
 memory problems, irritable bowel
 symptoms, etc.
It’s not a real illness, it’s in the
    “patient’s head”

         FALSE

A real condition with severe physical effects in
  some, although psychologic factors including
  depression may be the major determinant of
  pain in others
The prognosis is “hopeless”

          FALSE

Early, aggressive treatment can prevent
 physical deconditioning and loss of
 function
Dedicated to my family
for making everything worthwhile
READ not to contradict or confute
Nor to Believe and Take for Granted
but TO WEIGH AND CONSIDER


THANK YOU
     MY SINCERE THANKS TO
            PFIZER

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Management of fibromyalgic syndrome

  • 1. MANAGEMENT OF FIBROMYALGIC SYNDROME Prof. A.V. SRINIVASAN M.D,D.M,PhD,DSc,FIAN,FAAN Emeritus Professor – The Tamil Nadu Dr. MGR Medical University
  • 2. OUTLINE What is Fibromyalgia (FMS)? What causes it? Who gets it? How is it diagnosed? How is it treated? What are some of the common misconceptions about the syndrome?
  • 3. What is Fibromyalgia (FMS)? A clinical syndrome characterized by widespread muscular pain (usually chronic), fatigue and muscle tenderness (tender points)
  • 4. What is FMS? (cont.) Additional symptoms are common and include: - poor sleep almost always - headaches - irritable bowel syndrome - cognitive and memory problems “fibro fog” - numbness and tingling in fingers and toes
  • 5. What is FMS? (cont.) - irritable bladder - temporomandibular joint (TMJ) disorder - restless leg syndrome - dry eyes and dry mouth - morning stiffness - anxiety and depression Symptoms including pain may wax and wane over time
  • 6. FMS Symptom Complex Pain, fatigue, & sleep disturbance are present in at least 86% patients ACR Fibromyalgia Diagnostic Criteria. National Fibromyalgia Research Association Web site. Available at: http://www.nfra.net/Diagnost.htm. Accessed October 18, 2007.
  • 7. What causes FMS? Cause is unknown Abnormally high levels of Substance P in spinal fluid in some patients Substance P important in transmission and amplification of pain signals to and from brain “Volume control” is turned up too high in brain’s pain centers
  • 8. What causes FMS? (cont) Familial tendency to develop FMS suggests genetic role Can be triggered by physical, emotional or environmental stressors such as car accidents, repetitive injuries and certain diseases Patients with Rheumatoid arthritis and SLE (Lupus) are more likely to develop FMS
  • 9. What causes FMS? (cont.) Other conditions such as Lyme disease and obstructive sleep apnea (OSA) have been associated with FMS Sleep deprivation with disruption of delta-wave sleep (non-REM stage IV) is associated with day-time fatigue and fibromyalgia syndrome
  • 10. Who gets FMS? Affects as many as 1 in 50 Americans Most common in middle-aged women Men and children may also develop the disorder Patients with RA, SLE and Ankylosing spondylitis are more likely Women who have a family member with FMS are more likely to develop it
  • 11. How is FMS diagnosed? A diagnosis is made by evaluation of symptoms and presence of tender points American College of Rheumatology Classification Criteria for Fibromyalgia (1990) …….widespread pain for at least 3 months and pain in 11 out of 18 tender point sites on digital palpation
  • 12. ACR classification criteria: fibromyalgia Both criteria must be satisfied – History of widespread pain for more than 3 months, on both sides of the body, above and below the waist, and axial skeleton (cervical spine, anterior chest, thoracic pain, or low back) – Pain in 11 of 18 tender point sites on digital palpation with approximate force of 4 kg. Presence of second clinical disorder does not exclude diagnosis of fibromyalgia.
  • 13. ACR Diagnostic Criteria for FMS History of widespread pain for at least 3 months – Pain on both sides of the body PLUS – Pain above and below the waist PLUS – Axial skeletal pain Pain in at least 11 of 18 tender-point sites on digital palpation – Thumb Pressure is Applied to 18 tender-point sites – Until Nail Bed is Starting to Blanch (~ 4 kg of pressure) Wolf et al. Arthritis Rheum. 1990;33:160-172.
  • 15. How is FMS diagnosed? (cont.) X-rays, blood tests, specialized scans such as nuclear medicine and CT, muscle biopsies are all normal Objective “markers of inflammation” such as ESR (erythrocyte sedimentation rate) are normal Must be distinguished from other common diffuse pain conditions such as RA, SLE, Hypothyroidism and Polymyalgia Rheumatica (PMR)
  • 16. How is FMS treated? Fibromyalgia is a chronic condition managed with both medications and physical modalities Medication therapy is largely symptomatic, as there is no definitive treatment cure for fibromyalgia
  • 17. General Recommendations Fibromyalgia should be recognized as a heterogeneous condition comprising of a range of symptoms & features – Effective management should take into account all these factors Optimal treatment therefore requires a multidisciplinary approach with – Combination of non-pharmacological and pharmacological treatment modalities – Tailored according to pain intensity, sleep disturbance, fatigue & other symptoms, and function – Associated co-morbidities – In discussion with the patient
  • 18. Available Treatment Modalities Mease P. J Rheumatol. 2005; 32 (suppl 75): 6. Carville, et al. Ann Rheum Dis. Doi:10.1136/ard.2007.071522. Goldenberg et al. JAMA. 2004; 292: 2388. Clauw DJ, Crofford LJ. Best Pract Res Clin Rheumatol. 2003; 17: 685. Arnold LM, et al. Arthritis Rheum. 2007;56:1336-1344.
  • 19. Pharmacological Modalities Short-Term Long-Term Drugs Efficacy Efficacy Safety/ Tolerability Amitriptyline Multiple - Anti-cholinergic, anti- small RCTs adrenergic, anti- histaminic, cardiac muscle suppressant effects Duloxetine 2 RCTs 1 RCT Insomnia, GI & CV effects (Pain) Gabapentin 1 RCT - Dizziness, somnolence, weight gain Pregabalin 4 RCTs 1 RCT (pain Dizziness, somnolence, & function) weight gain Tramadol 1 RCT - Dizziness, somnolence, headache, GI effects
  • 20. Stepwise Treatment of Fibromyalgia Confirm diagnosis Identify important symptom domains, their severity, and level of patient function Evaluate for comorbid medical and psychiatric disorders Assess psychosocial stressors, level of fitness, and barriers to treatment Provide education about fibromyalgia Review treatment options Arnold LM. Arthritis Res Ther. 2006;8:212. Available online: http://arthritis-research.com/content/8/4/212. Accessed February 28, 2007.
  • 21. Stepwise Treatment of Fibromyalgia (cont’d) As a first-line approach for patients with moderate to severe pain, trial with evidence-based medications Provide additional treatment for comorbid conditions Adjunctive CBT for patients with prominent psychosocial stressors, and/or difficulty coping, and/or difficulty functioning Encourage exercise according to fitness level Arnold LM. Arthritis Res Ther. 2006;8:212. Available online: http://arthritis-research.com/content/8/4/212. Accessed February 28, 2007.
  • 22. How is FMS treated? (cont.) Current studies suggest that the best pharmacologic treatment for treating pain and improving sleep disturbance includes: - Tricyclic compounds such as cyclobenzaprine (FLEXERIL) and amitriptyline (ELAVIL) - Dual reuptake inhibitors such as venlafaxine (EFFEXOR), duloxetine (CYMBALTA) and tramadol (ULTRAM)
  • 23. - SSRIs/ antidepressants such as fluoxetine (PROZAC), paroxetine (PAXIL) and sertraline (ZOLOFT) for depression and pain - Recent studies have shown that the anti- epileptics (seizure meds) gabapentin (NEURONTIN) and pregabalin (LYRICA) have been effective
  • 24. - NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen and naproxen are generally ineffective - Long acting opioids (narcotics) generally are not of great benefit either - Benzodiazepines such as diazepam (VALIUM) and clonazepam (KLONIPIN) may be useful for patients with restless leg syndrome or very severe sleep disturbance who have not responded to other therapies
  • 25. Other Therapies for FMS Complementary and alternative therapies have been used although not well studied in FMS - Therapeutic massage - Myofascial release therapy - Acupuncture
  • 26. Other Therapies for FMS Patient Self-Management - Schedule time to relax, including deep breathing and meditation - Establish routine for going to bed and waking up - Aerobic exercise on regular basis - Self-education i.e. Arthritis Foundation, National Fibromyalgia Assn. - Support group - Cognitive Behavioral Therapy (CBT)
  • 27. Common Misconceptions Eleven (11) out of 18 tender points needed to make the diagnosis of FMS (2005 ACR Classification Criteria) FALSE Tenderness can be widespread without tender points
  • 28. The major symptom in FMS is pain FALSE A variety of neurologic abnormalities may be described including numbness and tingling of the extremities, cognitive and memory problems, irritable bowel symptoms, etc.
  • 29. It’s not a real illness, it’s in the “patient’s head” FALSE A real condition with severe physical effects in some, although psychologic factors including depression may be the major determinant of pain in others
  • 30. The prognosis is “hopeless” FALSE Early, aggressive treatment can prevent physical deconditioning and loss of function
  • 31. Dedicated to my family for making everything worthwhile
  • 32.
  • 33. READ not to contradict or confute Nor to Believe and Take for Granted but TO WEIGH AND CONSIDER THANK YOU MY SINCERE THANKS TO PFIZER

Editor's Notes

  1. Pain, fatigue, and sleep disturbance are the most common symptoms of Fibromyalgia. • Fibromyalgia is a pain condition in which sleep disturbance and fatigue occur in at least 86% of patients • Patients sometimes present with other comorbid conditions, including depression • As with other chronic pain conditions (for example, back pain, osteoarthritis, or rheumatoid arthritis), co-morbid mood disorders such as depression or anxiety may sometimes be present in Fibromyalgia. Fatigue is often unexpected, inappropriate, or a delayed reaction to physical exertion Presence of CWP differentiates FMS from chronic fatigue syndrome Cognitive disturbances may include: Difficulty in thinking Loss of short term memory Inability to multi-task Impaired speed of performance Easy distractability Feelings of cognitive overload Mood disorders are common In a study by Arnold, etc, 31% patients with FMS had a current diagnosis of MDD and 45% had moderate to severe anxiety
  2. The ACR criteria are a sensitive (88.4%) and specific (81.1%) tool that can be used to differentiate Fibromyalgia from other rheumatological conditions The digital palpation examination should be performed with an approximate force of 4 kg/1.4 cm2 [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” Axial skeletal pain Cervical spine Anterior chest Thoracic spine Low back
  3. Sodium oxybate Central nervous system depressant with marked sedative properties Enhances slow-wave sleep Sodium oxybate (sodium salt of GHB) granted Orphan Drug Status for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy Dose 4.5-9.0 g/day 2 equally divided doses (HS and 4 hours later) Milcinapran Primary mechanism of action is balanced reuptake inhibition Also weakly antagonizes NMDA receptor Approved in 30 countries as an antidepressant .
  4. Key Points The challenges that fibromyalgia presents call for a systematic, stepwise approach to treatment. Once a diagnosis is confirmed, it is crucial to identify the extent and severity of symptoms and possible comorbidities. This may require referral to a specialist. Educating the patient and reviewing all treatment options will also contribute to successful treatment. References Arnold LM. Biology and therapy of fibromyalgia: New therapies in fibromyalgia. Arthritis Res Ther . 2006;8:212. Available online: http://arthritis-research.com/content/8/4/212.
  5. Key Points The recent increase in interest and research in fibromyalgia has resulted in new, evidence-based approaches to treatment. Cognitive-behavioral therapy that addresses disability, function, and self-efficacy can yield positive results when added to medical treatment, as can exercise, as long as it is tailored to the individual’s general level of fitness. 1 Non-narcotic drugs with proven efficacy should be the first-line approach. Drugs with a likelihood of abuse or dependence should generally be avoided in patients with fibromyalgia. References Arnold LM. Biology and therapy of fibromyalgia: New therapies in fibromyalgia. Arthritis Res Ther . 2006;8:212. Available online: http://arthritis-research.com/content/8/4/212.