Chronic Pain, Fibromyalgia, Myofascial Pain
Conditions
Keywords
fibromyalgia, Myofascial
Brief summary
This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.
Interventions
DRUGIMC-1
Sponsors
Innovative Med Concepts, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of fibromyalgia * English speaker
Exclusion criteria
* Rheumatologic diseases * Bipolar disease, OCD, severe anxiety, schizophrenia * Systemic infection, severe cardiac disease, chronic steroid usage * chronic opioid usage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain from baseline | 16 weeks | Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change | 16 weeks | Patients will rate their global improvement over the duration of the trial |
| Fibromyalgia Impact Questionnaire | 16 weeks | — |
Countries
United States
Outcome results
None listed