![](media/image1.png){width="5.96875in" height="0.41944444444444445in"}

Top of Form

## Complete Summary

#### GUIDELINE TITLE

Fibromyalgia treatment guideline.

#### BIBLIOGRAPHIC SOURCE(S)

University of Texas, School of Nursing, Family Nurse Practitioner
Program. Fibromyalgia treatment guideline. Austin (TX): University of
Texas, School of Nursing; 2005 May. 13 p. \[18 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory information
has been released.

-   [May 2, 2007, Antidepressant
    drugs](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant):
    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.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Fibromyalgia

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Nursing\
Rheumatology\
Sleep Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Nurses\
Patients\
Physician Assistants\
Physicians\
Psychologists/Non-physician Behavioral Health Clinicians

#### GUIDELINE OBJECTIVE(S)

-   To guide practice decisions that integrate medical, pharmacological,
    and behavioral elements for treatment

-   To enhance the quality and functionality of life for the patient

-   To interpret and integrate the latest research to effectively manage
    patients with fibromyalgia

-   To delineate the criteria for definite diagnosis and treatment

-   To obtain the highest level of patient compliance and satisfaction
    with therapeutic and pharmacologic management

#### TARGET POPULATION

Women, age 50 to 65 years old who meet the diagnostic criteria for
fibromyalgia syndrome, including widespread pain of more than 3 months
duration in all four quadrants of their body and pain present in at
least 11 of the 18 specified tender points

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Evaluation**

1.  Subjective assessment, including history, comorbid conditions, and
    symptoms

2.  Physical examination, including vital signs, bilateral digital
    palpitation, and Fibromyalgia Impact Questionnaire

3.  Diagnostic laboratory tests

    -   Comprehensive metabolic panel (CMP)

    -   Complete blood count (CBC)

    -   Thyroid-stimulating hormone (TSH) measurement

    -   Triiodothyronine (T3) and thyroxine measurement

    -   Sedimentation rate

    -   Liver panel

    -   Creatinine phosphokinase measurement

4.  Psychological analysis

5.  Musculoskeletal assessment

6.  Neurological assessment

7.  Attended in-laboratory polysomnography

**Treatment/Management**

1.  Patient and family education

2.  Pharmacological treatment

    -   Tricyclic antidepressants (TCAs) (i.e., amitriptyline),
        cyclobenzaprine, or benzodiazepines to ensure adequate sleep

    -   Addition of selective serotonin reuptake inhibitor (SSRI) (i.e.,
        fluoxetine) to tricyclic antidepressant to treat fatigue and
        depression

    -   Cyclobenzaprine or low-dose benzodiazepine (i.e., clonazepam) to
        treat muscle spasms

    -   Tramadol for pain control

> Note: Non-steroidal anti-inflammatory agents and opioids were
> considered, but not recommended.

3.  Non-pharmacological treatment

    -   Exercise and massage

    -   Tender or trigger point injections

    -   Referral to appropriate specialty (i.e., psychotherapy)

#### MAJOR OUTCOMES CONSIDERED

-   Quality of life

-   Level of pain

-   Sleep

-   Muscle strength

-   Physical mobility

-   Daily activity functioning

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases\
Searches of Unpublished Data

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The following resources were reviewed:

1.  Nationally recognized, expert standards established by the American
    College of Rheumatology Diagnostic Criteria

2.  Nationally recognized, expert association literature obtained from
    the American Medical Association, National Institute of Arthritis
    and Musculoskeletal and Skin Diseases (NIAMS). and the U.S.
    Department of Health and Human Services

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Subjective Review\
Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**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

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Articles were reviewed for applicability for target population and for
validity and reliability of research methods and results.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Informal Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Synthesis and interpretation of the latest guidelines and research

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Strength of Recommendations**

A.  There is good evidence to support the recommendation.

B.  There is fair evidence to support the recommendation.

C.  There is insufficient evidence to recommend for or against, but
    recommendations may be made on other grounds.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

A draft of the guideline was developed by a group of family nurse
practitioner (FNP) students and submitted for review to the family nurse
practitioner faculty. A final review was performed by an external
expert, and subsequent changes were made prior to submitting to
guidelines committee.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Levels of evidence (I, II-1, II-2, and III) and recommendation grades
(A-C) are defined at the end of the \"Major Recommendations\" field.

**Subjective Assessment**

**History**

1.  Assessment of nature of pain, intensity, location, onset,
    aggravating and relieving factors

2.  Assessment of functionality

3.  Assessment of sleep disturbances and persistent fatigue

4.  Trauma history

5.  Gynecological history

6.  Assessment of comorbid conditions such as:

    -   Migraine or tension headaches

    -   Dysmenorrhea

    -   Irritable bowel syndrome

    -   Restless leg syndrome

    -   Depression

    -   Anxiety

    -   Sicca syndrome (Sjogren\'s syndrome)

    -   Cognitive or memory impairment

    -   Female urethral syndrome

**Symptoms**

1.  Musculoskeletal symptoms:

    -   Widespread pain at multiple sites

    -   Stiffness

    -   Sensation of hurting all over

    -   Diffuse soft tissue swelling

2.  Non-musculoskeletal symptoms:

    -   Fatigue

    -   Morning fatigue

    -   Sleep difficulties

    -   Paresthesias

**Past Medical History**

1.  Note hospitalizations, surgeries, and/or procedures

**Medication History**

1.  Current prescription medications

2.  Any and all over-the-counter medications, including alternative
    medicines or herbal treatments

3.  Ascertain previous fibromyalgia treatment (i.e., sleeping pills,
    selective serotonin reuptake inhibitors \[SSRIs\], tricyclic
    antidepressants \[TCAs\], pain medications, including narcotics) and
    note response.

**Family History**

1.  Rheumatoid arthritis

2.  Systemic lupus erythematosus

3.  Osteoarthritis

4.  Hypothyroidism

5.  Psychological disorders (i.e., depression, psychosis, anxiety)

6.  Raynaud\'s phenomena/disease

7.  Irritable bowel syndrome

8.  Migraine headaches

**Psychosocial History**

1.  Evaluate pain and coping skills using appropriate screening tools
    such as the Chronic Pain Coping Inventory (CPCI) (Nielson & Jensen,
    2004).

2.  Evaluate availability of support systems (i.e., financial support,
    insurance, Social Security Disability Insurance \[SSDI\], Medical or
    disability).

3.  Elicit occurrence of any traumatic or stressful life events and the
    possible relation of symptoms to these events.

4.  Assessment of lifestyle choices (i.e. exercise, alcohol, caffeine,
    tobacco, illicit drug use)

5.  Impact of symptoms on the patient\'s family, interpersonal
    relationships, work, school, and activities of daily living

6.  Psychosocial history including depression and suicidal ideation
    evaluation

**Objective Assessment**

**Physical Examination**

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](http://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]{.underline}. 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]{.underline}. 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)]{.underline}. 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]{.underline}. 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]{.underline}. 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]{.underline}. 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]{.underline}. 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]{.underline} recommended because
    fibromyalgia is not an anti-inflammatory process. Opioids are
    [not]{.underline} 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]{.underline}. 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**

A.  There is good evidence to support the recommendation.

B.  There is fair evidence to support the recommendation.

C.  There is insufficient evidence to recommend for or against, but
    recommendations may be made on other grounds.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=7352)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence is identified and graded for selected
recommendations (see \"Major Recommendations\").

These recommendations were based primarily on sources such as national
guidelines, meta-analysis review, and evidenced-based, randomized,
controlled research studies. Guidelines and statements are synthesized
to make them applicable to the treatment of fibromyalgia.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Improved identification of patients with fibromyalgia syndrome

-   Improved treatment and management of patients with fibromyalgia
    syndrome

-   Improved quality of life for patients with fibromyalgia syndrome

-   Decreased cost of care

-   Increased societal understanding and acceptance of fibromyalgia
    syndrome

#### POTENTIAL HARMS

Adverse side effects of medications

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These guidelines are not intended for use outside the stated
    population.

-   The independent skill and judgment of the healthcare provider must
    always dictate treatment decisions.

-   These practice guidelines are meant to serve as a general framework
    for managing clients with fibromyalgia syndrome. It may not always
    be appropriate to use these guidelines to manage clients because
    individual circumstances may vary. For example, different treatments
    may be appropriate for clients who are severely ill or who have
    comorbid, socioeconomic or other complicating conditions.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

University of Texas, School of Nursing, Family Nurse Practitioner
Program. Fibromyalgia treatment guideline. Austin (TX): University of
Texas, School of Nursing; 2005 May. 13 p. \[18 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005 May

#### GUIDELINE DEVELOPER(S)

University of Texas at Austin School of Nursing, Family Nurse
Practitioner Program - Academic Institution

#### SOURCE(S) OF FUNDING

University of Texas at Austin, School of Nursing, Family Nurse
Practitioner Program

#### GUIDELINE COMMITTEE

Practice Guidelines Committee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Erin Brewerton, RN, MSN, FNP, Kim Miller, RN, MSN, FNP,
Roxanne Nemec, RN, MSN, FNP, Mary Youngwith, RN, MSN, FNP

*External Reviewer*: Janet Morrison, RN, MSN, CNS

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: None available.

Print copies: Available from the University of Texas at Austin, School
of Nursing. 1700 Red River, Austin, Texas, 78701-1499

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on July 28, 2005. The information
was verified by the guideline developer on August 12, 2005. This summary
was updated by ECRI Institute on November 9, 2007, following the U.S.
Food and Drug Administration advisory on Antidepressant drugs.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which may be
subject to the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
site. Moreover, the views and opinions of developers or authors of
guidelines represented on this site do not necessarily state or reflect
those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or
hosting of guidelines in NGC may not be used for advertising or
commercial endorsement purposes.

Readers with questions regarding guideline content are directed to
contact the guideline developer.

Bottom of Form

© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008