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LET for Fibromyalgia

NCT07201818 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

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.

Sponsors & Collaborators

  • Arcturus Star Products

    collaborator UNKNOWN

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Jason Zafereo, M.P.T, Ph.D. · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-10-31
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201818 on ClinicalTrials.gov