Fibromyalgia Musculoskeletal Diseases Fibromyalgia
Conditions
Interventions
Participants are randomly allocated to one of two groups by the research pharmacist using a computer-generated randomization code.
Group 1: Participants are treated with alpha-lipoic
Sponsors
Physicians Services Incorporated Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 and older 2. Meeting the 2010 American College of Rheumatology diagnostic criteria for fibromyalgia 3. Experienced at least moderate daily pain (Numerical Rating Scale = 4/10) for at least 3 months prior to study entry 4. AST (aspartate aminotransferase)/ALT (alanine aminotransferase) no greater than 20% the upper limit of normal 5. Serum creatinine no greater than 50% the upper limit of normal 6. Necessary abilities, visual acuity and language skills for pain diary completion and telephone communication with study nurses
Exclusion criteria
Exclusion criteria: 1. Any major organ system disease 2. Major poorly controlled psychiatric disorder 3. Severe depression or suicidal ideation 4. Active substance abuse disorder 5. Lactose intolerance 6. Hypersensitivity to ALA 7. Painful condition more than 50% as severe as their fibromyalgia pain 8. Unwillingness to use a highly effective form of contraception (women of childbearing potential)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity is measured using mean daily “average” pain intensity at maximal tolerated dose, of each period is determined by averaging the daily pain intensity, as measured using the 0-10 Numerical Rating Scale over the 7 days of week 4 of each treatment period (alpha-lipoic acid and placebo). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse effects are measured using ratings of frequency and severity of treatment-emergent adverse effects weekly throughout the study 2. Fibromyalgia pain impact is measured using the fibromyalgia Impact Questionnaire at 4 and 9 weeks 3. Sleep quality is measured using the Medical Outcomes Study Sleep Scale at 4 and 9 weeks 4. Global treatment response is measured using the Patient Global Impression of Change at 4 and 9 weeks 5. Fibromyalgia pain impact is measured using the Brief Pain Inventory at 4 and 9 weeks 6. Mood is measured using the Beck Depression Inventory-2 at 4 and 9 weeks 7. Anxiety is measured using the Beck Anxiety Inventory at 4 and 9 weeks 8. Pain quality descriptors are measured using the short form McGill Pain Questionnaire at 4 and 9 weeks 9. Quality of life is measured using the SF-36 survey at 4 and 9 weeks 10. Quality of treatment blinding is measured using a blinding questionnaire at 4 and 9 weeks 11. Acetaminophen consumption is measured using a daily diary at 4 and 9 weeks | — |
Countries
Canada
Outcome results
None listed