Pilot Study of Homeopathic Treatment of Fibromyalgia Syndrome (HOFS)

INTERVENTION: Product Name: arnica Pharmaceutical Form: CONDITION: Fibromyalgia syndrome. A chronic musculoskeletal pain disorder of unknown aetiology, characterized by widespread pain and muscle tenderness, and often accompanied by fatigue, sleep disturbance and depressed mood. PRIMARY OUTCOME: Main Objective: To evaluate the comparative effectiveness of a homeopathy intervention relative to usual care Primary end point(s): Change in Fibromyalgia Impact Questionnaire total score from baseline to final visit (total duration 22 weeks) Secondary Objective: To estimate parameters necessary for a definitive trial INCLUSION CRITERIA: Primary Fibromyalgia diagnosis (according to American College of Rheumatologists criteria) Aged 18 or over Score of 4 or more on Fibromyalgia Impact Questionnaire pain scale (score ranging 0 ‐ 10 with 10 indicating very severe pain) at initial revruitmant/assessment interview Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range