Effectiveness of the interactional and interdisciplinary school of fibromyalgia: a long-term randomized control study / Eficácia da escola interrelacional e interdisciplinar de fibromialgia: estudo randomizado controlado em longo prazo

ABSTRACT BACKGROUND AND OBJECTIVES: This study assessed long-term efficacy of an interdisciplinary group intervention of patients with fibromyalgia as compared with standard medical care. METHODS: A partially randomized controlled study with two groups and repeated measures. Variables were measured at baseline; immediately after the program; 4 months and 1 year later. Fibromyalgia patients were recruited by newspaper ads or physician references from two Quebec regions. Sixty women suffering from fibromyalgia were randomized to the experimental group (ISF) or the control group CG. The program, called Interactional School of Fibromyalgia (ISF), consists of nine sessions with eight participants and two clinicians. Five variables were measured: Fibromyalgia Impact Questionnaire (FIQ), Physical and Mental components summary of Short Form Health Survey 36 (SF-36), Clinical pain, and pressure pain threshold at tender points. RESULTS: Efficacy analyses from completers, as well as intent-to-treat analyses, showed a treatment effect on measures even one year after the end of the program. The experimental group experienced lower FIQ scores (p<0.01), less clinical pain (p<0.05), higher pressure-pain thresholds (p<0.01), and higher physical component summary scores on the SF-36 (p<0.05). CONCLUSION: This interdisciplinary group intervention of patients with fibromyalgia demonstrated better long-term outcomes compared with standard medical care.

RESUMO JUSTIFICATIVA E OBJETIVOS: Este estudo avaliou a eficácia em longo prazo de uma intervenção interdisciplinar em grupo de pacientes com fibromialgia, comparando-a ao atendimento médico padrão. MÉTODOS: O estudo foi realizado randomicamente com dois grupos e coleta de dados de repetição. As variáveis foram medidas antes do início do programa; imediatamente após o programa; 4 meses e 1 ano depois. Os pacientes com fibromialgia foram recrutados por anúncios em jornais ou referências médicas, de duas regiões de Quebec. Sessenta mulheres que sofriam de fibromialgia foram randomizadas para o grupo experimental (EIF) ou o grupo controle (GC). O programa, denominado Escola Interrelacional de Fibromialgia (EIF), consiste em nove sessões com oito participantes e dois clínicos. Cinco variáveis de resultados foram medidas: Questionário de Impacto da Fibromialgia (QIF), resumo de componentes físicos e mentais do Short Form Health Survey 36 (SF-36), dor clínica e limiar de dor por pressão em pontos sensíveis. RESULTADOS: As análises de eficácia dos que completaram o programa, bem como as análises de intenção de tratar, mostraram um efeito de tratamento nas medições mesmo um ano após o término do programa. O grupo experimental apresentou pontuações mais baixas do QIF (p<0,01), menos dor clínica (p<0,05), os mais altos limiares de dor por pressão (p<0,01) e as mais altas pontuações do resumo de componente físico no SF-36 (p<0,05). CONCLUSÃO: Esta intervenção interdisciplinar em grupo de pacientes com fibromialgia demonstrou melhores resultados em longo prazo em comparação com os cuidados médicos padrão.

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

BACKGROUND: This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. METHODS: A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. RESULTS: The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. CONCLUSION: The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register ISRCTN14526380.

The deficit of pain inhibition in fibromyalgia is more pronounced in patients with comorbid depressive symptoms.

BACKGROUND: On pathophysiologic grounds, fibromyalgia (FM) is characterized by a deficit in diffuse noxious inhibitory controls (DNIC), but the role of depressive symptoms on these mechanisms has not been investigated. We hypothesized that the deficit in pain inhibition would be more pronounced in FM patients with depressive symptoms (FM+D), relative to patients without such symptoms (FM-D). METHODS: Fifty-two women diagnosed with FM (American College of Rheumatology criteria) and 10 healthy women participated in this study. Thermal stimuli were used to measure pain thresholds and DNIC efficacy (spatial summation paradigm). Clinical pain was measured using visual analog scales. RESULTS: We found that the amplitude of DNIC was smaller in FM+D patients, relative to the FM-D group; and that daily pain (unpleasantness) was higher in the FM+D group, relative to FM-D patients. DISCUSSION: We found that FM+D patients have a more pronounced deficit in pain inhibition as well increased clinical pain. As such, these results show the usefulness of combining psychologic factors and psychophysical measures to identify subgroups of FM patients. These results may have implications for future treatment of FM patients with and without comorbid depressive symptoms.

Fibromyalgia subgroups: profiling distinct subgroups using the Fibromyalgia Impact Questionnaire. A preliminary study.

The main goal of this project was to identify the presence of fibromyalgia (FM) subgroups using a simple and frequently used clinical tool, the Fibromyalgia Impact Questionnaire (FIQ). A total of 61 women diagnosed with FM participated in this study. FM subgroups were created by applying a hierarchical cluster analysis on selected items of the FIQ (pain, fatigue, morning tiredness, stiffness, anxiety and depressive symptoms). We also tested for group differences on experimental pain, psychosocial functioning and demographic characteristics. Two cluster profiles best fit our data. FM-Type I was characterized by the lowest levels of anxiety, depressive and morning tiredness symptoms, while FM-Type II was characterized by elevated levels of pain, fatigue, morning tiredness, stiffness, anxiety and depressive symptoms. Both FM subgroups showed hyperalgesic responses to experimental pain. These results suggest that pain and stiffness are universal symptoms of the disorder but that psychological distress is a feature present only in some patients.

Escola inter-relacional de fibromialgia: aprendendo a lidar com a dor: estudo clínico randomizado / Interactional school of fibromyalgia: learning to cope with pain: a randomized controlled study

OBJETIVO: Avaliar os efeitos tardios de um programa interdisciplinar para pacientes com síndrome de fibromialgia (FM) e comparar esses efeitos com o tratamento tradicional (acompanhamento médico, exames, medicamentos). MÉTODO: O tratamento proposto, denominado Escola Inter-relacional de Fibromialgia (EIF), consiste de um programa interdisciplinar de 11 semanas, com nove encontros com grupos de oito pacientes e dois profissionais da saúde. Trinta mulheres com FM participaram do grupo experimental e outras 30 do grupo-controle. Ambos os grupos foram avaliados em três momentos distintos: antes da EIF, imediatamente após e quatro meses após a alta. As pacientes que constituíam o grupo experimental foram também reavaliadas 12 meses após obterem alta. As variáveis dependentes foram: dor clínica e nível de disposição (ambas adquiridas por escalas visuais analógicas), cinco escalas do inventário multidimensional da dor (gravidade da dor, interferência da dor nas atividades cotidianas, percepção de controle da vida, distúrbios emocionais e suporte familiar/social). RESULTADOS: Com taxa de participação de 97 por cento, as pacientes do grupo experimental apresentaram melhora significativa após o tratamento e nas avaliações seguintes. Esta melhora significativa do quadro clínico também foi constatada quando comparada à evolução das pacientes do grupo-controle. Por meio da análise das variâncias (2 × 3) nos dados da amostra tratada, e teste t de Student pareado para a população intent-to-treat, percebe-se que o grupo experimental apresenta redução significativa das dores (todos os p < 0,05). A melhora das pacientes durante o tratamento manteve-se inalterada até um ano após a alta. CONCLUSÃO: O programa da EIF permite a obtenção de melhora significativa e estável na condição clínica das pacientes com FM. Com o artigo, segue discussão sobre estratégias para favorecer a participação ativa das pacientes.

OBJECTIVE: To assess long-term efficacy of an interdisciplinary group intervention of patients with fibromyalgia (FM) as compared with (Canadian) standard medical care. METHODS: The program, called Interactional School of Fibromyalgia (ISF), consists of 9 meetings (during 11 weeks) with eight participants and two facilitators. Sixty women with FM were randomly assigned to one of two groups (ISF or Control group). Outcomes variables were: clincal pain and energy (Visual analogue scale and five Multidimentional Pain Iventory (Pain severtity, Pain iterference, Life control, Affective distress and Support from significant others). These variables were measured at baseline; immediately after the program; 4 months and 1 year later. RESULTS: Efficacy analyses from completers showed a treatment effect on measures even after one year. The aderence of ISF was 97 percent. Analyses of variance (2 × 3) and Intent-to-treat analyses indicate that ISF group experienced lower pain (all ps < 0,05) even at the one year follow up. CONCLUSION: These findings demonstrate the long-term efficacy of this group intervention. Strategies to increase patients' adherence were discuted.

Is TENS purely a placebo effect? A controlled study on chronic low back pain.

Although high-frequency low-intensity transcutaneous electric nerve stimulation (TENS) has been extensively used to relieve low back pain, experimental studies of its effectiveness have yielded contradictory findings mainly due to methodological problems in pain evaluation and placebo control. In the present study, separate visual analog scales (VAS) were used to measure the sensory-discriminative and motivational-affective components of low back pain. Forty-two subjects were randomly assigned to 1 of 3 groups: TENS, placebo-TENS, and no treatment (control). In order to measure the short-term effect of TENS, VAS pain ratings were taken before and after each treatment session. Also, to measure long-term effects, patients rated their pain at home every 2 h throughout a 3-day period before and 1 week, 3 months and 6 months after the treatment sessions. In comparing the pain evaluations made immediately before and after each treatment session, TENS and placebo-TENS significantly reduced both the intensity and unpleasantness of chronic low back pain. TENS was significantly more efficient than placebo-TENS in reducing pain intensity but not pain unpleasantness. TENS also produced a significant additive effect over repetitive treatment sessions for pain intensity and relative pain unpleasantness. This additive effect was not found for placebo-TENS. When evaluated at home, pain intensity was significantly reduced more by TENS than placebo-TENS 1 week after the end of treatment, but not 3 months and 6 months later. At home evaluation of pain unpleasantness in the TENS group was never different from the placebo-TENS group.(ABSTRACT TRUNCATED AT 250 WORDS)