Effectiveness of a Structured Group Intervention Based on Pain Neuroscience Education for Patients with Fibromyalgia in Primary Care: a Multicentre Randomized Open-Label Controlled Trial

Background There has been increased interest in pain neuroscience education (PNE) as a therapeutic approach for the management of fibromyalgia (FM). Methods A multicentre randomized, open-label, controlled trial was conducted to assess the effectiveness of a structured group intervention based on PNE in patients with FM. A total of 139 patients were included in the study and randomized to the intervention group (7 group sessions of education in neurobiology of pain) or to the control group (treatment as usual only). The primary outcome was the improvement of functional status and pain measured with the Fibromyalgia Impact Questionnaire (FIQ), and secondary outcomes were the reduction in the impact of pain and other symptoms (catastrophizing, anxiety and depression) and number of patients reaching no worse than moderate functional impairment (FIQ score <39). Differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Results At 1 year, improvements in FIQ scores were higher in the intervention group with moderate or high effect size, and decreases of >= 20% in 69.1% of patients (20.9% in the control group) and of >= 50% in 39.7% (4.5% in the control group). Also, 52.9% of patients had a FIQ <39 points (13.4% in the control group). Conclusions In this sample of patients with FM, the improvement in quality of life and control of symptoms obtained by adding a PNE intervention showed promising results, equalling or surpassing previously reported outcomes. Significance A structured group intervention based on pain neuroscience education for 1 year in patients with fibromyalgia was associated with significant amelioration of the impact of the disease on scores of the Fibromyalgia Impact Questionnaire, the Health Assessment Questionnaire, the Hospital Anxiety and Depression Scale, the Pain Catastrophizing Scale and the Polysymptomatic Distress Scale as compared with only treatment as usual. These findings are clinically relevant considering the challenges posed by fibromyalgia to clinicians and patients alike.Partial reduction of routine work tasks of the principal investigator, MJ Barrenengoa-Cuadra, was supported by a grant from OSI Bilbao Basurto Osakidetza, Basque country, Spain (the grant was paid to the Health Service to substitute MJ Barrenengoa-Cuadra while research work)

Effectiveness of pain neuroscience education in patients with fibromyalgia: Structured group intervention in Primary Care

Objective: To evaluate the effectiveness of a group intervention in Primary Care in patients with fibromyalgia (FM) based on pain neuroscience education (PNE). Design: Pre-post study.Location: Urban Primary Health Centre in Bilbao. Participants: Patients with FM (2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia), ≥ 18 years. Intervention: 5 weekly sessions (2 hours each), and a reminder session one month later. Main measurements: Compliance with FM criteria, assessed using the WPI (Widespread Pain Index, number of pain areas) and the SS (severity of symptoms) questionnaires. An assessment was also made on the impact of FM on functional capacity (FIQ: ≥ 20% and ≥ 50% reduction in the FIQ total score from baseline to after treatment, and proportion of patients with FIQ< 39 at the end of the study). Assessments were made at baseline, one month following the 5th session, and during the 6- and 12-month follow-up. Results: All the study evaluations were completed by 85/98 patients. A statistically significant improvement was observed in the 3 studied categories (WPI, SS, and FIQ) since the first visit, and was maintained until the final visit (12 months later). A total of 45 patients (53%, 95% CI: 42%-63%), more than those at baseline, scored FIQ< 39 (no worse than mild functional impairment). One month following the 5th session there were 44 patients (52%, 95% CI: 41%-62%) that no longer met FM criteria and, at the end of follow-up, there were 56 patients (66%, 95% CI:55%-75%). Conclusions: An intervention based on PNE has shown to be feasible in Primary Care, with results in the upper range of those published with other treatments for FM.La presente investigación recibió una beca de la Convocatoria de Ayudas a la Investigación de la OSI Bilbao Basurto de Osakidetza durante los años 2015 y 2016. Asimismo, recibió una ayuda de la Comisión de Investigación del Hospital Galdakao-Usansolo de Osakidetza en la 2.a Convocatoria de Financiación de Actividades de Investigación de 2019.YesObjetivo: Evaluar la efectividad de una intervención grupal en atención primaria en pacientes con fibromialgia (FM), basada en la educación en neurociencia del dolor (Pain Neuroscience Education, PNE). Diseno: ˜ Estudio de intervención antes-después.Emplazamiento: Centro de Salud urbano de Bilbao. Participantes: Pacientes con FM (criterios diagnósticos 2010 del American College of Rheuma tology), ≥ 18 años. Intervención: Cinco sesiones semanales (2 h cada una), y una sesión de recuerdo un mes después.Mediciones principales: Cumplimiento de criterios de FM, mediante los cuestionarios WPI (número de áreas de dolor) y SS (gravedad de los síntomas), e impacto de la FM sobre la capacidad funcional (FIQ: reducción ≥ 20% y ≥ 50% sobre la puntuación basal, y proporción de pacientes con FIQ< 39 al final del estudio). Se hicieron evaluaciones al inicio, al mes de la 5.a sesión, 6 y 12 meses después. Resultados: Completaron todas las evaluaciones del estudio 85/98 pacientes. Se objetivó una mejoría estadísticamente significativa en las 3 categorías estudiadas (WPI, SS y FIQ) desde la primera visita, mantenida hasta la visita final (12 meses después). Cuarenta y cinco pacientes (53%, IC: 42-63%) más que al inicio tuvieron una puntuación en el FIQ< 39 (impacto funcional no grave). Al mes de finalizar la 5.a sesión había 44 (52%, IC: 41-62%) que ya no cumplían criterios de FM y al final del seguimiento 56 (66%, IC: 55-75%). Conclusiones: Una intervención basada en PNE ha mostrado ser factible en atención primaria, con resultados en el rango superior de los publicados con otros tratamientos para FM