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.
Conditions
Interventions
Product Name: arnica
Pharmaceutical Form:
Sponsors
Barnsley Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Pain from traumatic injury or structural disease Secondary Fibromyalgia Rheumatoid arthritis Inflammatory arthritis Autoimmune disease Immunosuppressant drugs Current oral steroid treatment Substance abuse in the last year Primary psychiatric diagnosis or medication prior to onset of Fibromyalgia Unstable medical or psychiatric illness Chronic use of sedatives Pregnant or breastfeeding Current acupuncture treatment Homeopathic treatment in previous three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the comparative effectiveness of a homeopathy intervention relative to usual care;Secondary Objective: To estimate parameters necessary for a definitive trial;Primary end point(s): Change in Fibromyalgia Impact Questionnaire total score from baseline to final visit (total duration 22 weeks) | — |
Countries
United Kingdom
Outcome results
None listed