N/A N=51 Treatment

Study of T3 for the Treatment of Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT00903877 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Jul 2017

Primary outcome: Primary: Visual Analogue Scale of Pain Intensity — 6.75; 5.71; 5.13; 6.19 Units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: T3 (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analogue Scale of Pain Intensity	6.75; 5.71; 5.13; 6.19	—

Summary

Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.

Eligibility Criteria

Inclusion Criteria

Age 18-50
Meet american college of rheumatology criteria for fibromyalgia
at baseline report an average pain of 4 or more on a brief Pain Inventory.
can climb 2 flights of stairs without shortness of breath.

Exclusion Criteria

new medication change in the last 2 months
any cardiac disease at all
known thyroid disease before or after thyroid screening bloodwork
unstable medical or psychiatric disease.
Known inflammatory or rheumatic disease other than fibromyalgia
substance abuse in the last year
suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
concomitant herbal medications
multiple severe medication allergies
the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
diabetes
smoking
Known uncontrolled hypertension
known uncontrolled hypercholesterolemia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00903877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.