Auriculotherapy treatment in fibromyalgia: A randomized trial

Introduction: A multidimensional approach is recommended for fibromyalgia (FM). Auriculotherapy, a complementary therapy based on normalizing body dysfunction by treating points on the external ear, has never been studied in FM. Objective: To assess the efficacy of auriculotherapy in the quality of life of FM patients. Design: Randomized placebo-controlled clinical trial. Setting/Location: Tertiary care university hospital, Suresnes, France. Subjects: Female patients, 18 to 80-years-old, presenting with FM. Interventions: Participants were randomized to one of three arms: TT group (auriculotherapy true treatment), NST group (needle sham treatment), and VSST group (vaccaria seeds sham treatment). They received their treatment three times at one-month intervals. Outcome Measures: Primary outcome was the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcomes included pain scores, pain medications, sleep quality, fatigue, anxiety, depression, cognition, physical functional capacity, an..., Randomized, controlled single-center trial was performed in a tertiary care university hospital, in accordance with the Declaration of Helsinki . Ethical approval for this study was provided by the Ethical Committee of CPP Ile de France VIII (n° 151288, December 17, 2015). The study was published on the Clinical.trials.gov website (May 6, 2016, NCT02764788) The process of Auriculotherapy was conducted according to STRICTA guidelines {MacPherson, 2010 #10907}.&nbsp; Three arms: TT group (auriculotherapy true treatment), NST group (needles sham treatment), and VSST group (vaccaria seeds sham treatment). Patients received their treatment three times at one-month intervals.&nbsp; Data were collected at five times: at inclusion; after each of the three treatments; early after the third treatment session with a maximal delay of two weeks (main outcome); three months after the end of the treatment. Patients completed a questionnaire with the help of an investigator if necessary. The main obje..., , Two files are included: * INCLUSION: data describing patients at inclusion * MEASUREMENTS: data observed during treatment Note that \"na\" indicates \"not available\" ### INCLUSION * id_data: Patient number * Group: \"TT group: auriculotheray true treatment: NST group: needle sham treatment: VSST group: vaccaria seeds sham treatment\" * Age: \"1: <50 years: 2: 50 years and +\" * Time since onset of symptoms: , years * Number of painful points: number * WPI: Widespread pain index ranging from 0 to 19 * SS: Symptom severity score * FIQ: Fibromyalgia impact questionnaire ranging from 0 to 100 * Pain during the visit: 11-point numerical pain scale from 0 to 10 (from 0, no pain, to 10, the worst pain imaginable) * Pain during last 24 hours: 11-point numerical pain scale from 0 to 10 (from 0, no pain, to 10, the worst pain imaginable) * Pain during last week: 11-point numerical pain scale from 0 to 10 (from 0, no pain, to 10, the worst pain imaginable) * MOS: Medical outcomes study sleep scale...,