Diagnosis of Fibromyalgia Syndrome—A Comparison of
Association of the Medical Scientific Societies in Germany,
Survey, and American College of Rheumatology Criteria
Winfried Ha¨user, MD,*w Sebastian Hayo,* Werner Biewer, MD,z Mechthild Gesmann, MD,y
Hedi Ku¨hn-Becker, MD,J Frank Petzke, MD,z Hubertus von Wilmoswky, MD,#
Objectives: The survey and the Association of the Medical Scientific
Although not developed as a diagnostic tool, the
American College criteria (ACR) for the classification
Societies in Germany (AWMF) criteria had been developed to
of fibromyalgia syndrome (FMS), namely the presence
overcome problems associated with tender point criterion of the
of chronic widespread pain (CWP) and at least 11 of 18
American College of Rheumatology (ACR) (lacking validation
painful tender points (TP) on manual pressure,1 have
for clinical diagnosis, inconsistent use by rheumatologists, and
become the de facto diagnostic criteria used for basic
nonrheumatologists) for the clinical diagnosis of fibromyalgiasyndrome (FMS). We compared the concordance between these
research and clinical studies on FMS.2 A major problem
with the TP criterion for the definition of FMS is its biastoward the selection of females and individuals with high
Methods: Consecutive patients of different clinical settings referred
levels of physical and psychologic distress,3,4 out of the
for the evaluation of chronic widespread pain or management
10 –26% of persons with CWP in the general population.5
of established FMS diagnosis were assessed by medical history,
There is general agreement between medical disciplines
a complete physical examination including tender points, andquestionnaires [self-constructed symptoms questionnaire, regional
that the symptom of ‘‘chronic widespread pain (CWP)’’, as
pain scale (RPS), Patient Health Questionnaire (PHQ 9 and 15)].
defined by the ACR (axial plus upper and lower body plus
FMS according to AWMF-criteria was diagnosed by the history of
left-sided and right-sided pain)1 or by epidemiologic criteria
widespread pain (axial and all 4 extremities), the symptoms sleep
(pain in the axial skeleton and all 4 extremities),5 is essential
disturbances, fatigue, and feeling of swelling or stiffness of the
for the clinical diagnosis of FMS. If other symptoms such
hands or feet or face (Numeric rating scale Z1/10 each symptom)
as fatigue and nonrestorative sleep or physical findings such
and the exclusion of somatic diseases sufficiently explaining the
as tenderness on pressure on at least 11/18 tender points
symptoms. FMS according to survey criteria was diagnosed by
should be used as adjuncts for the clinical diagnosis of FMS
regional pain scale score Z8 and fatigue score Z6/10 on a visual
is under debate. Wolfe claimed that clinicians should stop
using TP examination (TPE) for the clinical diagnosis
Results: Out of 310 patients, 292 could be analysed. AWMF and
of FMS.6 In contrast Harth and Nielson concluded from a
ACR were concordant in 86.6%, AWMF and survey criteria were
narrative review of the literature that TPE is useful in the
concordant in 78.8% and survey and ACR-criteria were con-
Alternative tools for the clinical diagnosis of FMS had
Discussion: AWMF, survey, and ACR criteria were moderately
been suggested. Katz et al2 and Wolfe8 made the clinical
concordant. As AWMF and survey criteria do not require tender
diagnosis of FMS by clinician’s experience considering
point examination, these criteria can be used by nonrheumatol-
clinical criteria such as pain, fatigue, sleep disturbance,
ogists for the clinical diagnosis of FMS.
comorbidity, and psychosocial variables without specifyingthe rules of diagnosis. Wolfe developed a questionnaire,
Key Words: fibromyalgia syndrome, diagnosis, American College
named the Regional Pain Scale (RPS) that assesses 19
of rheumatology, Association of the Medical Scientific Societies in
articular and nonarticular body regions for the presence
of pain. He suggested survey criteria characterized by the
combination of at least 8/19 painful body areas on the RPSand a score of Z6 on an 11 point visual analogue scalefor fatigue. This approach correctly identified most patients
Received for publication September 23, 2009; revised January 20, 2010;
diagnosed with FMS by their rheumatologists based on the
From the *Department of Internal Medicine I, Klinikum Saarbru¨cken
clinical criteria mentioned above.8 Within 1 rheumatologic
gGmbH, Winterberg 1; zRheumatological Practice, Saarbru¨cken;
practice the concordance rates of the ACR, survey, and
wDepartment of Psychosomatic Medicine, Technische Universita¨t
clinical criteria of FMS were between 72% to 75%.2 These
Mu¨nchen, Mu¨nchen; zDepartment of Anesthesiology and Post-operative Intensive Care Medicine, University of Cologne, Cologne;
data have not been replicated in other settings.
#Department of Rheumatology, Knappschaftskrankenhaus Pu¨ttlin-
Coordinated by the Association of the Medical
gen, Pu¨ttlingen; **Department of Internal Medicine V, (Comple-
Scientific Societies in Germany (AWMF) and the German
mentary and Integrative Medicine), University of Duisburg-Essen,Kliniken Essen-Mitte, Germany; yPsychosomatic Medicine Prac-
Interdiscplinary Association for Pain Therapy, 10 German
tice, Herford; and JPain Medicine Practice, Zweibru¨cken.
medical and psychologcial scientific societies (general med-
Reprints: Winfried Ha¨user, MD, Klinikum Saarbru¨cken gGmbH,
icine, rheumatology, pain medicine, orthopaedic surgery,
Winterberg 1, D-66119 Saarbru¨cken, Germany (e-mail: whaeuser@
psychiatry, psychosomatic medicine, neurology, psychology),
Copyright r 2010 by Lippincott Williams & Wilkins
and 2 self-help organisation developed an evidence-based
Clin J Pain Volume 26, Number 6, July/August 2010
Clin J Pain Volume 26, Number 6, July/August 2010
and consensus-based guideline on the classification, diag-
nosis, and therapy of FMS.9 The guideline classified FMS
If patients reported a diagnosis of FMS or if FMS was
as a functional somatic syndrome.10 Thus, the clinical
suspected by medical history and/or pain drawings, patients
diagnosis should be based on symptoms and the exclusion
were asked to complete these questionnaires: A self-
of somatic diseases which sufficiently explain CWP by
constructed sociodemographic and medical questionnaire
carrying out a complete clinical examination and defined
assessing age, sex, duration of CWP and FMS-diagnosis,
routine blood tests.9 On the basis of studies on the main
partnership and professional status and the symptoms sleep
symptoms of FMS-patients in different clinical settings,11–13
disturbances, mental and physical fatigue, feeling of
these additional symptoms besides CWP are required for
swelling or stiffness of the hands, feet, and legs on an 11
the clinical diagnosis of FMS: sleep disturbances and
point a numeric rating scale; the RPS8, and the Patient
mental or physical fatigue and feeling of swelling or
Health Questionnaire PHQ 9 and 15.15,16 The PHQ is a
stiffness of the hands or feet or legs. These criteria were
self-administered version of the Primary Care Evaluation
supported by the consensus committee, but have not been
of Mental Disorders diagnostic instrument for common
validated in epidemiologic or clinical studies.
mental disorders. To assess somatic symptoms and
The aim of this study was to compare the concordance
depressed mood, the respective parts of the validated
of the 3 diagnostic criteria in different clinical settings to
German version of the PHQ were used.17 The PHQ-15
overcome potential selection and investigator bias. Further-
comprises 13 somatic symptoms from the PHQ, each
more, we assessed if the different diagnostic criteria would
symptom scored from 0 (‘‘not bothered at all’’) to 2
lead to different sociodemographic and clinical profiles of
(‘‘bothered a lot’’). PHQ-15 scores of 5,10,15 represent
cutoff points for low, medium, and high somatic symptomseverity, respectively. The usefulness of the PHQ-15 inscreening for somatisation and in monitoring somatic
symptom severity in clinical practice and research had been
shown in numerous studies.16 The PHQ-9 is the depressionmodule of the PHQ, which scores each of the 9 DSM-IV
The study was carried out in 1 rheumatologic practice
criteria as ‘‘0’’ (not at all) to ‘‘3’’ (nearly every day). Validity
(WB), 1 outpatient department of rheumatology of a
has been assessed against an independent structured mental
district hospital (SH supervised by HvW), 1 pain medicine
health professional interview. PHQ-9 scores of 0 to 4
practice (HKB), 1 university pain clinic (FP), 1 psychoso-
indicate no depression, 5 to 9 mild depression, 10 to 14
matic medicine practice (MG), 1 psychosomatic medicine
moderate depression, 15 to 19 moderately severe depres-
universitarian outpatient department (WH), and 1 depart-
sion, and 20 to 27 severe depression.15 As items of the PHQ
ment of integrative medicine of an academic teaching
9 and 15 comprise key symptoms of FMS, namely pain,
hospital (JL). SH was a junior physician who was trained
sleep disturbances, and fatigue, we calculated modified sum
for this project for his doctoral thesis. The other investi-
scores of these questionnaires by removing the items c
gators were experienced clinicians who were working with
(sleep problems), d (lack of energy), and g (trouble
FMS-patients for at least 10 years. The patients underwent
concentrating) from the PHQ 9 and the items b (back
a complete physical assessment by these researchers. The
pain) and c (pain in extremities) from the PHQ 15. Item d
investigators had been instructed to carry out TPE
(menstrual cramps or other problems with periods) was
according to the manual tender point survey protocol.14
Consecutive patients referred to the settings detailed
The concordance of the 3 different diagnostic criteria
above for the evaluation and/or management of CWP, with
was calculated by the percentage of the sum of positive and
and without established diagnosis of FMS, were included
negative agreements between 2 pairs of diagnostic criteria
during the period of January to June 2009. Patients with
each. Up to 25% of missing items in the PHQ 9 and 15 were
somatic diseases, for example active inflammatory rheu-
substituted by the individual median. If more than 25%
matic disease, sufficiently explaining CWP, diagnosed by
items were missing, the questionnaire was excluded from
clinical examination, and laboratory testing, were excluded.
analysis. Missing items in the RPS and symptom ques-
Patients with inactive somatic diseases, for example
inflammatory rheumatic disease in remission not explaining
To assess differences between groups, we compared
mean scores of continuous demographic and clinical
Diagnoses of FMS were made according to the ACR
variables by analyses of variance (ANOVAS) with posthoc
(CWP as defined by the ACR and tenderness on pressure of
2 group comparisons by the Dunnett-T3 test. w2 analysis
at least 11/18 TP), survey (RPS score Z8/19 and fatigue
was used for categorical variables. All tests were 2-tailed,
score Z6/10 on a visual analogue scale in the last week),
with the a-value set at 0.01 because of multiple compar-
and AWMF-criteria (CWP defined as axial pain and pain in
isons. All analyses were conducted with SPSS Version 17.0
all 4 extremities assessed by medical history and/or pain
drawing and the report of sleep disturbances and fatigueand feeling of swelling or stiffness of the hands or feet orface in the last 3 mo with a score scale Z1/10 on a numeric
rating scale on a self-constructed symptom questionnaire).
One of 311 patients approached refused to take part
All patients gave their informed consent to data
in the study. Three hundred ten patients participated. Of
collection and analysis. The study was approved by the
these, 16 patients were excluded because no complete data
respective regional and institutional ethics committees if
set of the 3 diagnostic criteria were available. Furthermore,
2 patients who reported to be diagnosed with FMS were
Clin J Pain Volume 26, Number 6, July/August 2010
excluded because they did not meet any of the 3 diagnostic
were owing to a TP count <11. Twenty-nine percent ACR-
criteria. Thus, 292 patients were included into analysis. In
negative cases did not meet the ACR-criterion of CWP.
81/292 (27.7%) of the patients FMS was diagnosed for the
AWMF and ACR were concordant in 86.6% (range
first time. The sex ratio of the patients, the low educational
77.1 to 100), AWMF and survey criteria were concordant in
level, the high levels of work disability, and physical and
78.8% (range 66.7 to 90.2), and survey and ACR-criteria
somatic distress of most of the patients of the study sample
were concordant in 79.5% (69.2 to 86.9) of the cases.
are consistent with known characteristics of FMS-patients
There were no significant overall differences in the concor-
in clinical settings and studies2 (Table 1). Yet, it is
dances of the 3 diagnostic criteria between the study centers
important to note that FMS was diagnosed also in a
(Table 2). There were no significant differences of the
minority of highly educated patients and in patients with
concordances of the 3 diagnostic criteria between patients
low levels of reported additional somatic and psychologic
with initial and established diagnosis of FMS (Table 3).
distress. Only few significant differences of sociodemo-
Patients who were positive in all 3 diagnostic criteria
graphic and clinical characteristics of the patients were
reported higher levels of depressed mood and somatic
found between the study centers. The outpatient psycho-
symptom severity than patients positive only in AWMF
somatic department recruited more male patients than the
other study centers. The percentage of patients with a higheducational level was larger in the department of integrative
medicine than in the other study centers (details notreported).
The intercorrelationships of the 3 diagnostic groups
Alternative criteria for the clinical diagnosis of FMS
are shown graphically in Figure 1. Seventy-one percent of
had been developed, to overcome problems associated with
the patients were diagnosed with FMS by all 3 methods.
the use of the tender point criterion of the ACR for the
Isolated positive cases were noted (1.4%, 3.1%, and 2.0%
clinical diagnosis, and to offer nonrheumatologists alter-
respectively, diagnosed by AWMF only, by survey only,
natives of diagnosing FMS without TPE. These alternative
and by ACR criteria only). AWMF negative cases were all
criteria are the survey criteria and the criteria of the
owing to lacking CWP defined as pain axially and in all
Association of the Medical Scientific Societies in Germany.
4 extremities. Survey negative cases were all owing to a
We compared the concordance of these 3 criteria in
fatigue score <6. A majority of ACR negative cases (71%)
different clinical settings in patients referred for the
TABLE 1. Sociodemographic and Clinical Characteristics of the Total Study Sample (N=292)
PHQ 15 somatic symptom severity score (0-26)
PHQ 15 somatic symptom severity score modified (0-22)
PHQ indicates patient health questionnaire; RPS, regional pain scale.
Clin J Pain Volume 26, Number 6, July/August 2010
Why Are Alternative Criteria for the ClinicalDiagnosis of FMS Required?
There are several practical and scientific reasons to
develop alternative criteria for the clinical diagnosis of
a. A standardized manual tender point survey is avail-
able,14 but this protocol is not used in rheumatologic
practice and in most clinical studies on FMS. Even with
the standardization of manual TPE, there is the risk of
‘‘the harder you press (the more you believe?), the more
b. The reliability and validity of the TP examination
outside the context of FMS-specialized rheumatologic
c. FMS is not a disease exclusively diagnosed and
treated by rheumatologists. Patients are also diagnosed
and treated by general practitioners, pain physicians,
or psychiatrists.18–21 TPE is largely ignored in these
settings. Nonrheumatologists, had not been trainedfor TPE within their residency program. Moreover,TPE would be time consuming in these settings. Even
FIGURE 1. Venn diagram showing the intercorrelationship of
if a competent physician of whatever discipline who
the Association of the Medical Scientific Societies in Germany
is able to conduct a thorough medical examination
(AWMF) criteria, Survey criteria, and American College of
could be taught a standardized manual TPE, the time
to carry out this examination could be used to extracta more comprehensive psychosocial history. There-fore, the development of alternative diagnostic criteria
evaluation of CWP or management of established FMS.
without TPE had been demanded by these medical
We found moderate concordance between the 3 diagnostic
criteria within this data set of FMS patients. We found
d. Although increased tenderness or hyperalgesia/allo-
no significant differences of concordance between the 3
dynia to pressure stimuli had been replicated by other
diagnostic criteria comparing patients with initial diagnosis
more objective ways of assessment,4,22 its relevance
of FMS and patients with established FMS. The con-
and specificity for the diagnosis of FMS had been
cordances of diagnoses did not differ between the different
settings. Patient’s positive by all 3 diagnostic criteriareported higher levels of distress than patients positive onlyby AWMF and ACR criteria.
Differences Between the DiagnosticCriteria of FMS Available
There are some differences between the suggested
alternatives to the ACR criteria for clinical diagnosis. The
Katz et al reported a concordance of survey and ACR
survey criteria had been developed on patients with FMS,
criteria of 72.3%,2 which was comparable with the 1 in our
rheumatoid arthritis (RA), and osteoarthritis (OA) in a
study with 79.3% (range 71.4 to 86.7). The concordance
rheumatologic practice setting. The items were selected to
of the 3 diagnostic criteria in our study was higher than
achieve a maximum discrimination between patients with
between the 3 diagnostic criteria in the study of Katz et al
FMS against patients with RA and OA. However, 29% of
the patients with RA and 33% of the patients with OA also
TABLE 2. Overall Agreement Between the 3 Different Criteria for the Diagnosis of Fibromyalgia Syndrome in Different Settings
Department of Complementary Medicine N=60
*P<0.05; Not significant because of adjusted P value of multiple comparisons. ACR indicates American College of Rheumatology; AWMF, Association of the Medical Scientific Societies in Germany; n.s., not significant; RPS, regional
Clin J Pain Volume 26, Number 6, July/August 2010
TABLE 3. Comparison of Concordances of 3 Different Diagnostic Criteria of Fibromyalgia Syndrome, Stratified to Patients With InitialDiagnosis, and Established Diagnosis of Fibromyalgia Syndrome
fulfilled the survey criteria of FMS.1 Katz et al claimed
expert consensus for the clinical diagnosis. The choice
that the survey method has the advantage that it does not
of symptoms was not determined by the intention to
require an additional physical examination.2
discriminate FMS from other diseases by these symptoms.
The AWMF criteria had been suggested by a struc-
The main symptoms of FMS, namely musculoskeletal pain,
tured consensus of an interdisciplinary panel of experts of
fatigue, and sleep disturbances, are also prevalent in the
all medical and psychologic disciplines engaged in the care
general population and in other somatic diseases and in
of FMS patients and of representatives of FMS-patients.8
depressive disorder-although FMS patients can be clearly
The most frequent symptoms reported by FMS-patients in
differentiated from depressive disorders by the intensity of
different settings (>98% of the patients)11,12 were chosen by
reported pain and fatigue.13 The separation of FMS from
TABLE 4. Comparison of Demographic and Clinical Characteristics of Patients With Different Concordances of 3 Different DiagnosticCriteria of Fibromyalgia Syndrome
*P<0.05 Not significant because of adjusted P value of multiple comparisons. **P<0.01. ***P<0.001.
Clin J Pain Volume 26, Number 6, July/August 2010
somatic diseases sufficiently explaining CWP is carried out
syndromes too, for example the Manning and Rome I, II,
by medical history, complete physical examination, and
and III criteria for irritable bowel syndrome.30
laboratory tests.9 Thus, even if the AWMF criteria do not
Until a better clinical case definition of FMS exists,
require TPE, a physical examination is indispensable for the
all diagnostic criteria should be interpreted with caution
initial diagnosis of FMS. The time required to exclude other
and subject to modification.29 The ACR criteria seem to be
medical causes of CWP is longer than TPE.
indispensable for clinical studies. The mean TP count of
The exclusion of somatic diseases sufficiently explain-
9 to 10 in our ACR-negative cases suggests that a lower TP
ing CWP is not required by the survey and ACR criteria,
count criterion than 11 might be appropriate for the clinical
but by the AWMF criteria and a Canadian expert
diagnosis of FMS by the ACR-criteria. Katz et al found
consensus on FMS.24 The exclusion of somatic diseases
that a TP count discriminated maximally at a count Z6 for
sufficiently explaining the symptoms is required for the
diagnosis of functional somatic syndromes (eg, irritable
AWMF and survey diagnoses do not require TPE
bowel syndrome) in other medical disciplines too.10 More-
which is 1 of the major obstacles for the diagnosis of FMS
over, the evidence of the efficacy of pharmacologic
in nonrheumatologic settings. Thus, AWMF and survey
treatment of FMS is based on randomised controlled trials
criteria can replace the ACR-criteria for clinical diagnosis
that excluded patients with somatic diseases as potential
of FMS in nonrheumatologic settings. Studies comparing
the preference and applicability of the AWMF and surveycriteria by nonrheumatologists at all levels of care are
necessary to find out if these diagnostic tools meet the needs
of nonrheumatologists and possess reasonable sensitivity
Patients with moderate and high levels of somatic
and specificity. In case the AWMF-criteria will be accepted
and psychologic distress were diagnosed irrespectively of
by nonrheumatologists, studies should be conducted if
the criteria used in our study. We found some socio-
FMS will be diagnosed earlier by nonrheumatologists and
demographic and clinical differences in cases of lacking
if management and outcome of FMS will improve.
concordance. Our study showed that the AWMF criterialed more frequently to a diagnosis of FMS in men thanthe ACR-criteria. This finding is in line with the results ofepidemiologic studies. The ACR—criteria are associated
with a sex ratio (women to men) of 6 to 8:1 in epidemiologic
1. Wolfe F, Smythe HA, Yunus MB, et al. The American College
and clinical studies. Leaving the TP-criterion leads to
of Rheumatology 1990 criteria for the classification of
a more balanced sex ratio.3 Branco et al reported an
fibromyalgia. Report of the multicenter criteria committee.
estimated prevalence of FMS in the general population
of 5 European countries based on positive screens in the
2. Katz RS, Wolfe F, Michaud K. Fibromyalgia diagnosis:
London Fibromyalgia Epidemiologic Study Screening
a comparison of clinical, survey, and American College ofRheumatology criteria. Arthritis Rheum. 2006;5:169–176.
of 2.9% with a ratio women to men of 1.7.5 The prevalence
3. Clauw DJ, Crofford LJ. Chronic widespread pain and
of FMS diagnosed by the RPS in a representative sample of
fibromyalgia: what we know, and what we need to know. Best
the general German population was 3.8% with an equal
Pract Res Clin Rheum. 2003;17:685–701.
4. Petzke F, Gracely RH, Park KM, et al. What do tender points
measure? Influence of distress on four measures of tenderness.
The spectrum of medical disciplines involved in the
5. Branco JC, Bannwarth B, Failde I, et al. Prevalence of
study was not complete, because general practitioners,
fibromyalgia: a survey in five European countries. Semin
orthopaedic surgeons, and psychiatrists did not participate.
Arthritis Rheum. 2009. [Epub Feb 26].
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6. Wolfe F. Stop using the American College of Rheumatology
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study protocol did not involve clinicians without special
them or lose them? A brief review of the controversy.
expertise in FMS. Therefore, no conclusions on the con-
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8. Wolfe F. Pain extent and diagnosis: development and
possible. We chose rates of overall agreement for measure
validation of the regional pain scale in 12, 995 patients.
of concordance and did not present k statistics,28 because
the inclusion and exclusion criteria of the study led to a
9. Ha¨user W, Eich W, Herrmann M, et al. Fibromyalgia syndrome:
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FMS.2,29 Doctor’s reports for patients with the diagnosis
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2009 ASO CVSCaremark Principal Life Prior Authorization and Des Moines, IA 50392-0002 Insurance Company Dispensing Limitation List The following drugs have a Dispensing Limitation (quantity limit per 30 days unless otherwise specified) Prescription Drug Quantity Limits Comments Limitation applies to drugs either singularly or in combination Limitation appli
Neuropharmacologic agents are used in traumatic brain injury (TBI) to enhance cognitive function, treat emotional disorders, minimize behavior dysfuction, decrease muscle tone, treat seizures, pain management, and treat sleep disorders. Cognitive function: As a general rule, the first step in any protocol for the use of neuropharmacologic agents is to do a review the patient’s medications and, i