Fibromyalgia Musculoskeletal Diseases Soft tissue disorders
Conditions
Interventions
Group one: Recuperat-ion®
Group two: placebo
A 15-day washout period was required (pre-treatment period). Response to therapy was evaluated at 30, 60, 90, 120, 150, and 180 days (treatment period),
Sponsors
Recuperat-ion Electrolitos, S.L. (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients between 18 and 65 years old 2. Has FM according to official diagnostic criteria for FM established in 1990 by the American College of Rheumatology (ACR) 3. Duration of the illness of ten years or less
Exclusion criteria
Exclusion criteria: 1. History of renal failure (creatinine equal to or superior than 1.8 mL/dL), coronary disease in the last six months, angina, congestive heart disease, diabetes mellitus type one and two 2. Any life-threatening chronic disease (i.e., cancer disease, inflammatory bowel disease and active immune disorders) 3. Rheumatic disease (i.e., inflammatory arthritis, polymyositis, polymyalgia rheumatica) 4. Osteomalacia and osteoporosis 5. Metabolic and endocrine disease (i.e., hypothyroidism and hyperthyroidism, hyperparathyroidism, adrenal insufficiency, metabolic myopathy) 6. Infectious diseases (i.e., Epstein-Barr virus disease, brucellosis) 7. Rheumatic disease of soft tissue and myofascial pain syndrome 8. Parkinson?s disease 9. Women to become pregnant or nursing 10. Patients who are enrolled in other clinical trial or patients who participated in other clinical trial in the last 30 days 11. Any psychological or psychiatric disease to compromise the understanding of the instructions giving by the investigator 12. Any subject to be unable to follow a good complementation of the treatment 13. Any patient who denies to give the informed consent to participate in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To ascertain the influence of an oral beverage solution (Recuperat-ion®) on pain, fatigue and mood in FM patients, measured at initial visit and at 30, 60, 90, 120, 150, and 180 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate: 1. General health status and quality of life (The Nottingham Health Profile), measured at initial visit and at 30, 60, 90, 120, 150, and 180 days 2. Psychological well-being (The Faces Scale, Hospital Anxiety and Depression Scale), measured at initial visit and at 30, 60, 90, 120, 150, and 180 days | — |
Countries
Spain
Outcome results
None listed