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NOT YET RECRUITING
NCT07201818
NA

LET for Fibromyalgia

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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.

Official title: A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-06

Completion Date

2028-01

Last Updated

2026-02-20

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Lymphatic 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.

DEVICE

Sham 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.

Locations (1)

UT Southwestern Medical Center in the Allied Health Physical Therapy Clinic

Dallas, Texas, United States