A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia
University of Texas Southwestern Medical Center
Summary
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.
Description
At enrollment, participants will complete a baseline assessment including collection of demographic information (age, race/ethnicity, BMI, employment status, duration of symptoms, smoking history), past/current medical history, and current medications. The primary outcome measure of severity and functional impact of fibromyalgia symptoms will be collected using the Fibromyalgia Impact Questionnaire Revised (FIQR) at baseline, at each of the four treatment sessions, and one month after the last treatment. The following secondary outcome measures will be collected at baseline, immediately after…
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * meeting the American College of Rheumatology 2016 diagnostic criteria for fibromyalgia, * female sex, * ages 18-65 years, * never received LET treatment, * an FIQ score ≥39 (moderate severity), and * no medication changes within 14 days prior to the start of the study or for the duration of the study. Exclusion Criteria: * currently receiving any other form of mind-body or exercise treatment, * active blood clots, * unexplained calf pain with concern for DVT, * active infection, * congestive heart failure, * presence of an implanted pacemaker, * pregnant or may be preg…
Interventions
- DeviceLymphatic Enhancement Technology (LET)
Lymphatic Enhancement Technology (LET) is an FDA-approved electrotherapeutic modality, with indications for addressing local lymphatic and vascular circulation as well as muscle pain and spasm. The Aria LET Elite Instrument (Arcturus Star, Cortez, Colorado) will be utilized for the intervention group.
- DeviceSham Lymphatic Enhancement Technology (LET)
A separate modified Aria Elite LET Instrument (Arcturus Star, Cortez, Colorado) will be utilized for the sham group. The sham LET device used for the control group will emit a light and sound similar to the true LET device, but will not emit energy waves.
Location
- UT Southwestern Medical Center in the Allied Health Physical Therapy ClinicDallas, Texas