Fibromyalgia Musculoskeletal Diseases Fibromyalgia
Conditions
Interventions
There are three treatment arms that cross over as per a balanced Latin square design.
Group 1: Participants receive oral pregabalin, administered twice daily, starting at a dose of 75 mg once daily
Sponsors
Canadian Institutes of Health Research (Canada), Strategy for Patient-Oriented Research (SPOR), Chronic Pain Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fibromyalgia 2. Daily pain (=3/10) for at least 3 months 3. AST/ALT =120% upper limit of normal 4. Creatinine clearance =60 ml/min 5. Necessary abilities, visual acuity, and language skills for questionnaire completion and phone communication with research personnel 6. Adults over the age of 18
Exclusion criteria
Exclusion criteria: 1. Patients with major organ system disease, moderate to severe sedation or ataxia due to other required drugs, hypersensitivity to study medications, seizure disorder, or other painful condition >50% as severe as their fibromyalgia pain 2. Patients with a major, poorly controlled, psychiatric disorder, severe depression or suicidal ideation, or active substance abuse disorder 3. Patients who live alone and cannot assure daily contact with a friend, family member, or caregiver 4. Women of childbearing potential will be required to receive a highly effective form of contraception and a negative pregnancy test at baseline 5. Allergy or hypersensitivity to any of the study medications 6. Seizure disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean daily pain, measured using a 0-10 numerical rating scale with 0 = no pain, 10 = worst pain imaginable, averaged over the maximally tolerated dose fixed dose week (days 39-45) of each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain, measured by 0-10 numerical rating scale at baseline and daily throughout entire trial 2. Pain, measured by short-form McGill Pain Questionnaire at baseline and during maximal tolerated dose of each of the three treatment periods 3. Drug doses, measured in milligrams over the 7-day maximal tolerated dose phases of each of the three treatment periods 4. Adverse events, measured in % frequency over the titration phases, maximal tolerated dose phases and dose taper/washout phases of each of the three treatment periods 5. Global relief, measured with the global relief category scale during the maximal tolerated dose phases of each of the three treatment periods 6. Pain interference, measured with the Brief Pain Inventory and the Fibromyalgia Impact Questionnaire at baseline and during the maximal tolerated dose phases of each of the three treatment periods 7. Mood, measured with the Beck Depression Inventory-2 at baseline and during the maximal tolerated dose phases of each of the three treatment periods 8. Anxiety, measured with the Beck Anxiety Inventory at baseline and during the maximal tolerated dose phases of each of the three treatment periods 9. Quality of life, measured with the SF-36 survey at baseline and during the maximal tolerated dose phases of each of the three treatment periods 10. Blinding, measured with a blinding questionnaire during the maximal tolerated dose phases of each of the three treatment periods 11. Acetaminophen consumption, measured in milligrams during the dose taper/washout phases of each of the three treatment periods | — |
Countries
Central African Republic
Outcome results
None listed