LET for Fibromyalgia

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07201818
Status
Not Yet Recruiting

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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lymphatic Enhancement Technology (LET) — DEVICE
    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.
  • Sham Lymphatic Enhancement Technology (LET) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active LET group
    Participants in the active/real LET group will be treated with a machine that emits lights, sounds, and electrostatic energy. Three additional treatments will be administered over three weeks.
  • Sham Comparator: Sham LET group
    Participants in the placebo/sham LET group will be treated with a machine that emits lights and sounds, but no electrostatic energy. Three additional treatments will be administered over three weeks.

Primary Outcome Measure

Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline [ Time Frame: Baseline, Week 2 pre-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical Center in the Allied Health Physical Therapy ClinicDallasTexas75390
Jason Zafereo, M.P.T, Ph.D.
[email protected]
214/648-1002

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By research site
UT Southwestern Medical Center in the Allied Health Physical Therapy Clinic· Dallas, TX

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