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What must Fibromyalgia patients change
in order to improve their quality of life?
Xavier Torres, Antonio Collado, Anna Arias, Arancha Conesa.
Fibromyalgia Unit. Clinical Psychology Service. Rheumatology
Service. Hospital Clínic de Barcelona
1904: First definition of fibrositis




Page  2
The Fibromyalgia syndrome deteriorates quality of life...



 Worse HRQOL than normal population (equivalent in demographics)
  (Laas et al., 2009; Mas et al., 2008)
 Similar HRQOL than other chronic rheumatologic conditions (Martinez et
  al., 1995),
  – But Mental Health more affected (versus AR) (Birtane at al., 2007).
 Contradictory results compared to other chronic conditions:
  – Worse HRQOL (SF-36) compared to osteoarthritis, chronic obstructive
    pulmonary disease or diabetes (Burckhardt et al., 1993).
  – Worse HRQOL only in Pain and Vitality (SF-36) compared to urinary
    incontinence (elderly), prostate cancer, chronic obstructive pulmonary disease
    or AIDS (Schlenk et al., 1998).




Page  3
However...



 Follow-ups at 2-8 years:
  – Pain remains unchanged.
  – HRQOL, Life satisfaction, and Family situation improve.
  – Results independent of the treatment received (Noller & Sprott, 2003;
    Mengshoel & Haugen, 2001; Baumgartner & cols., 2002).
 Few studies.
 Cross-sectional designs.
 Correlational Analyses.




Page  4
Accordingly...



 The improvement of HRQOL must be a main therapeutic aim.
 The definition of those variables on which HRQOL improvement depends
  must guide the treatment of the Fibromyalgia.


 Aim: define, by means of a longitudinal prospective design, which
  are the clinical variables amenable to modification that better
  explain the improvement of the HRQOL of Fibromyalgia patients
  six months after having undergone a multidisciplinary treatment.




Page  5
Participants and Procedure



    90 FM patients (97.8% female) with a mean age of 43.7 (8.7) years,
     who suffered a Fibromyalgia syndrome of 8.6 (7.2) years of duration,
     underwent a 12-session multidisciplinary treatment (5 hours/day, 2
     days/week, 6 weeks).
    Re-assessment at 6 months follow-up.
    Change in clinical variables and HRQOL subscales:
    – Difference between pre and six-month after treatment scores.
    Statistical Analyses:
    1. Linear relations between predictors and SF-36 scales.
    2. Multivariate Regression Analyses.




Page  6
Results
                                                   SF-36
Depression (HAD-D)
                             R2=0.15
                                        Physical Functioning
Self-efficacy (activities)              (Limitation in performing
                                        physical activities)
Self-efficacy (pain)
                             R2=0.31
Self-efficacy (other                    Role-Physical (Problems with
physical symptoms)                      work or other daily activities as
                                        a result of physical health)
Fear/Avoidance of            R2=0.27
activity                                General Health (current and
                                        expected)
                             R2=0.15
Pain Locus of Control
                                        Vitality
(internal)
                              R2=0.26
Catastrophizing                         Social Functioning
                                        Social Functioning
                              R2=0.26
                                        Mental Health
Page  7
In summary...



 Six months after having undergone a multidisciplinary treatment, the
  improvement of the HRQL of Fibromyalgia patients seems to be mainly
  explained by:
  – The reduction of depressive symptoms.
  – The reduction of the fear and avoidance of activity.
  – The increase of the self-efficacy beliefs for performing activities and controlling
    pain and other symptoms.




Page  8
However...



 What must change in order to improve depression? SEM?
 Are Fear/Avoidance and Self-efficacy related? Principal Component Analysis?
 Models for Bodily Pain and Role Emotional not defined.
 The proportion of variance explained was modest (15-31%).
  – Sample size.
  – Analysis limited to variables amenable to modification.
       •   Exclusion of personality characteristics (neuroticism and alexithymia).
  – Non-inclusion of other modifiable variables:
       •   Body Mass Index.
       •   Persistence on activity:
           – Self-esteem and social recognition based on performance?
           – Excessive responsibility.



Page  9

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WHAT MUST FIBROMYALGIA PATIENTS CHANGE TO IMPROVE THEIR QUALITY OF LIFE

  • 1. What must Fibromyalgia patients change in order to improve their quality of life? Xavier Torres, Antonio Collado, Anna Arias, Arancha Conesa. Fibromyalgia Unit. Clinical Psychology Service. Rheumatology Service. Hospital Clínic de Barcelona
  • 2. 1904: First definition of fibrositis Page  2
  • 3. The Fibromyalgia syndrome deteriorates quality of life...  Worse HRQOL than normal population (equivalent in demographics) (Laas et al., 2009; Mas et al., 2008)  Similar HRQOL than other chronic rheumatologic conditions (Martinez et al., 1995), – But Mental Health more affected (versus AR) (Birtane at al., 2007).  Contradictory results compared to other chronic conditions: – Worse HRQOL (SF-36) compared to osteoarthritis, chronic obstructive pulmonary disease or diabetes (Burckhardt et al., 1993). – Worse HRQOL only in Pain and Vitality (SF-36) compared to urinary incontinence (elderly), prostate cancer, chronic obstructive pulmonary disease or AIDS (Schlenk et al., 1998). Page  3
  • 4. However...  Follow-ups at 2-8 years: – Pain remains unchanged. – HRQOL, Life satisfaction, and Family situation improve. – Results independent of the treatment received (Noller & Sprott, 2003; Mengshoel & Haugen, 2001; Baumgartner & cols., 2002).  Few studies.  Cross-sectional designs.  Correlational Analyses. Page  4
  • 5. Accordingly...  The improvement of HRQOL must be a main therapeutic aim.  The definition of those variables on which HRQOL improvement depends must guide the treatment of the Fibromyalgia.  Aim: define, by means of a longitudinal prospective design, which are the clinical variables amenable to modification that better explain the improvement of the HRQOL of Fibromyalgia patients six months after having undergone a multidisciplinary treatment. Page  5
  • 6. Participants and Procedure  90 FM patients (97.8% female) with a mean age of 43.7 (8.7) years, who suffered a Fibromyalgia syndrome of 8.6 (7.2) years of duration, underwent a 12-session multidisciplinary treatment (5 hours/day, 2 days/week, 6 weeks).  Re-assessment at 6 months follow-up.  Change in clinical variables and HRQOL subscales: – Difference between pre and six-month after treatment scores.  Statistical Analyses: 1. Linear relations between predictors and SF-36 scales. 2. Multivariate Regression Analyses. Page  6
  • 7. Results SF-36 Depression (HAD-D) R2=0.15 Physical Functioning Self-efficacy (activities) (Limitation in performing physical activities) Self-efficacy (pain) R2=0.31 Self-efficacy (other Role-Physical (Problems with physical symptoms) work or other daily activities as a result of physical health) Fear/Avoidance of R2=0.27 activity General Health (current and expected) R2=0.15 Pain Locus of Control Vitality (internal) R2=0.26 Catastrophizing Social Functioning Social Functioning R2=0.26 Mental Health Page  7
  • 8. In summary...  Six months after having undergone a multidisciplinary treatment, the improvement of the HRQL of Fibromyalgia patients seems to be mainly explained by: – The reduction of depressive symptoms. – The reduction of the fear and avoidance of activity. – The increase of the self-efficacy beliefs for performing activities and controlling pain and other symptoms. Page  8
  • 9. However...  What must change in order to improve depression? SEM?  Are Fear/Avoidance and Self-efficacy related? Principal Component Analysis?  Models for Bodily Pain and Role Emotional not defined.  The proportion of variance explained was modest (15-31%). – Sample size. – Analysis limited to variables amenable to modification. • Exclusion of personality characteristics (neuroticism and alexithymia). – Non-inclusion of other modifiable variables: • Body Mass Index. • Persistence on activity: – Self-esteem and social recognition based on performance? – Excessive responsibility. Page  9

Notas do Editor

  1. Malgrat ja fa més de cent anys de les primeres definicions de la fibromiàlgia (anteriorment anomenada fibrositis), la incertesa sobre l’etiologia de la fibromiàlgia i la impossibilitat d’incidir directament en les alteracions fisiopatològiques anteriorment descrites han propiciat que el tractament dels malalts sigui inespecífic, heterogeni i simptomàtic (normalment basat en els símptomes més predominants i consistent en l’administració de varis tipus de fàrmacs i tècniques no mèdiques). Malgrat els esforços emprats, encara no disposem d’un tractament definitiu per a la fibromiàlgia (l’eficàcia mitjana de qualsevol tractament farmacològic és una reducció del 30% del dolor).
  2. Per tant, es raonable suposar que la no remissió de la simptomatologia somàtica comporti un significatiu menyscapte de la qualitat de vida de les persones amb fibromiàlgia. La fibromiàlgia comporta un elevat sofriment i un greu deteriorament de la qualitat de vida en comparació amb la de les persones sanes de característiques demogràfiques equivalents i similar al d’altres malalties reumatològiques cròniques, però amb una especial afectació de la salut mental en comparació amb l’artritis reumatoide. Les comparacions amb altres malalties cròniques en quant a l’afectació de la qualitat de vida obtenen, no obstant, resultats dispars. Alguns estudis troben que la fibromiàlgia comporta una pitjor qualitat de vida en totes les subescales del qüestionari de qualitat de vida SF-36 en comparació amb l’artrosi, la malaltia pulmonar obstructiva o la diabetes insulino-dependent. No obstant, altres estudis observen que comparades amb persones ancianes amb incontinència urinària, o persones amb càncer de pròstata, malaltia pulmonar obstructiva, hiperlipidèmia o Síndrome d’Inmunodeficiència Adquirida, les persones amb fibromiàlgia presenten una major afectació de la qualitat de vida únicament en les subescales de dolor corporal i de vitalitat.
  3. La cronicitat de la fibromiàlgia hauria de comportar un comprensible deteriorament de la qualitat de vida de les persones que la pateixen. No obstant, varis estudis mostren que malgrat els símptomes es mantenen bàsicament estables després de les intervencions terapèutiques, la qualitat de vida dels pacients millora. En concret, entre dos i vuit anys després d’haver iniciat el tractament de la fibromiàlgia, el dolor es manté estable independentment del tipus de tractament rebut. La qualitat de vida, la satisfacció amb l’estat de salut i la situació familiar, no obstant, milloren. Per tant, la milloria de la qualitat de vida no ha de dependre de la milloria dels símptomes somàtics, al menys directament. Tanmateix els estudis que avaluen els determinants de la milloria de la qualitat de vida en la fibromiàlgia són pocs, i la majoria pateixen limitacions metodològiques com un disseny transversal o una anàlisi únicament correlacional que dificulten la obtenció de conclusions causals.
  4. Per tant, i tenint en compte el caràcter crònic dels símptomes de la fibromiàlgia, la milloria de la qualitat de vida dels pacients ha de ser un objectiu terapèutic prioritari. La definició dels factors dels que depèn aquesta milloria és fonamental per a guiar el tractament d’aquesta malaltia. Tenint en compte que la majoria dels estudis que intenten definir els determinants de la qualitat de vida de les persones amb fibromiàlgia utilitzen un disseny transversal i anàlisis correlacionals que no permeten concretar quines variables han de ser modificades per tal de que millori la qualitat de vida dels pacients, l’objectiu del nostre estudi fou analitzar mitjançant un disseny longitudinal prospectiu quines de les variables clíniques susceptibles de modificació expliquen la milloria de la qualitat de vida sis mesos després d’haver realitzat un tractament multidisciplinari per a la fibromialgia.
  5. Una sèrie consecutiva de pacients ambulatoris diagnosticats de fibromiàlgia va ser derivada des del Servei de Reumatologia per tal de valorar la idoneïtat per a iniciar un programa de tractament multidisciplinari. Els casos en els que el metge reumatòleg de la Unitat va confirmar el diagnòstic de fibromiàlgia es van incloure en el tractament. Tots els participants que van consentir-ho van iniciar un programa terapèutic de 12 sessions (5 hores/dia, 2 dies/setmana durant 6 setmanes). El tractament va incloure educació sobre la fibromiàlgia, tractament farmacològic, teràpia cognitivo-conductual (modificació del patró de persistència en l’activitat, reestructuració cognitiva de les idees de responsabilitat excessiva i de la por i evitació de l’activitat, i entrenament en assertivitat), teràpia física (exercici físic cardiovascular supervisat, estiraments, crioteràpia i estimulació elèctrica transcutània) i teràpia ocupacional (entrenament progressiu en l’execució ergonòmica d’activitats quotidianes i d’activitats laborals). Tots els participants van ser re-avaluats multidisciplinàriament al finalitzar el tractament i 6 mesos després de l’alta.
  6. Els resultats del nostre estudi suggereixen que la milloria de la qualitat de vida de les persones amb fibromiàlgia sis mesos després d’haver realitzat un tractament multidisciplinari depèn principalment: de la promoció de l’autoeficàcia i de les creences favorables a la possibilitat de controlar el dolor mitjançant recursos propis de l’afrontament actiu que comporta un increment de la capacitat funcional subjectiva de la reducció de les creences d’indefensió. Des del punt de vista clínic és interessant observar que milloria de la subescala de Salut mental fou explicada únicament per la reducció del factor 1 (Catastrofisme). El catastrofisme comporta creences d’indefensió (la idea de que, per molt que es faci, el dolor no millorarà), desesperança sobre les seqüeles i limitacions degudes al dolor i tant de manera transversal com longitudinal, i per a diferents malalties reumatològiques es relaciona amb el malestar afectiu (Edwards i cols., 2006a). És possible, doncs, que els casos de fibromiàlgia en els que es detectés una major afectació de l’estat d’ànim requereixen una major focalització en procediments terapèutics orientats a la modificació de les cognicions catastrofistes o bé que es beneficiessin de la modificació d’aquestes cognicions de manera prèvia a l’inici de procediments més complexos com un abordatge multidisciplinar. El Factor 7 (Lloc de control extern-Altres significatius) va explicar amb signe negatiu la milloria de la Funció física i amb signe positiu la milloria de la Funció social. Sembla, doncs, que si bé la reducció de la creença que el control del dolor depèn de l’ajut dels altres disminueix el grau en que el dolor limita les activitats físiques i els esforços, l’augment d’aquesta creença facilita que el dolor no interfereixi en la vida social. Aquesta observació pot ser especialment significativa des del punt de vista terapèutic ja que podria significar que el tractament dels pacients amb fibromiàlgia es beneficiaria de la promoció d’activitats físiques i esforços moderats i intensos disminuint progressivament l’assistència dels propers, mentre que la milloria de la vida familiar i social requeriria de la promoció de l’ajut per part de l’entorn.
  7. Cap dels factors definits en l’anàlisi de components principals va ser capaç d’explicar els canvis en les subescales Dolor corporal i Vitalitat (fatiga) del SF-36. Per tant, els resultats del nostre estudi indiquen que els canvis en els principals símptomes de la fibromiàlgia (el dolor i la fatiga) no depenen de cap de les variables avaluades. Com ja s’ha dit, les estratègies terapèutiques (tant mèdiques com no mèdiques) de que disposem actualment no són, malauradament, capaces de modificar les alteracions fisiopatològiques que semblen responsables del símptomes de la fibromiàlgia. Een la majoria dels casos la proporció de variància explicada fou, a tot estirar, moderada (entre el 15% i el 27%, excepte en la Funció social que fou del 53%). La grandària de la mostra pot haver limitat la potència del procediment estadístic. Només es van estudiar les variables susceptibles de modificació mitjançant tractament psicològic. Això pot haver exclòs variables importants com el neuroticisme i l’alexitímia (han explicat fins al 44% de la variància d’algunes de les subescales del SF-36 en síndromes doloroses com la colitis ulcerosa o la malaltia de Crohn). Tanmateix, altres variables modificables com, per exemple, l’Índex de massa corporal que es relaciona negativament amb la qualitat de vida de les persones amb fibromiàlgia no han estat avaluades en aquest estudi. Finalment, en l’actualitat no disposem de cap instrument per avaluar un aspecte que cada cop sembla més crucial en la fibromiàlgia. S’ha proposat que, a més d’utilitzar estratègies d’evitació d’activitats, existeix un subgrup de pacients amb dolor crònic que tendeixen a afrontar el dolor utilitzant de manera prioritària estratègies de manteniment de l’activitat. Aquests pacients tendeixen a persistir en l’activitat malgrat els provoqui increments de dolor, el que podria comportar un treball muscular excessiu i alhora podria constituir un factor de manteniment de la sensibilització central que s’ha observat en la fibromiàlgia. En el cas de la fibromiàlgia s’ha observat aquesta tendència a l’activitat excessiva i s’ha proposat tant com a factor etiològic com de manteniment. Malauradament, cap estudi ha explorat les raons que duen a les persones amb fibromiàlgia a mantenir aquest patró de comportament. Des del punt de vista clínic, és palès que les persones amb fibromiàlgia i els seus entorns són conscients de que el manteniment de l’activitat a pesar del dolor és una estratègia iatrogènica, però tant l’autoestima i el reconeixement social basats en el rendiment com la responsabilitat excessiva en dificulten la modificació, el que podria contribuir a mantenir els símptomes, les creences desadaptatives i les seves conseqüències pernicioses en la qualitat de vida. En el nostre estudi no s’han avaluat ni el grau de modificació del patró d’activitat excessiva ni la modificació de les creences de responsabilitat excessiva.