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}. 
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. 
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...,