The study is a double blinded, randomized, sham-controlled, parallel group trial conducted at UT Southwestern (UTSW) Medical Center. The purpose of this research study is to determine the effectiveness of Lymphatic Enhancement Technology (LET) treatment in patients with fibromyalgia. Participants will complete assessments of heart rate and blood pressure, pain thresholds to mechanical stimuli, and completion of quality-of-life surveys. In addition, participants will receive four treatments, one time per week, with either an active or sham LET device. Each visit will take between 45 minutes to 2 hours. A follow-up phone call or email from the study team will occur at 4 weeks after completion of the LET treatment. Total study duration is two months.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline
Timeframe: Baseline, Week 2 pre-treatment
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 3 from baseline
Timeframe: Baseline, Week 3 pre-treatment
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 4 from baseline
Timeframe: Baseline, Week 4 pre-treatment
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 8 from baseline
Timeframe: Baseline, Week 8