Lymphatic Enhancement Technology device for people with fibromyalgia, compared with a sham device
Tests a lymphatic enhancement device against a sham device in adults with fibromyalgia.
Key facts
- Who runs it
- University of Texas Southwestern Medical Center
- Where
- Dallas, United StatesSee the site
- Trial code
- Registry title
- LET for Fibromyalgia
- Status
- Not yet recruiting
- People taking part
- 40 people, planned
- Started
- Jun 2026
- Expected to end
- Jan 2028
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Lymphatic Enhancement Technology (LET)
- Sham Lymphatic Enhancement Technology (LET)
- Record updated
- 20 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18-65 with fibromyalgia of at least moderate severity. It tests a device called Lymphatic Enhancement Technology (LET) against a sham (fake) device.
- Age
- 18 to 65 years
- Sex
- Female only
- Disease stage
- Fibromyalgia diagnosed by the American College of Rheumatology 2016 criteria, with an FIQ score of 39 or more (moderate severity).
- Earlier treatment
- You cannot have had LET treatment before. No medication changes within 14 days before the study or during it. No steroid injections in the past 3 months.
Main reasons for not taking part
- Currently having another mind-body or exercise treatment
- Active blood clots, or unexplained calf pain that may be a clot (DVT)
- Active infection, congestive heart failure, or an implanted pacemaker
- Pregnant or may be pregnant
- Active cancer or receiving cancer treatment
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- currently receiving any other form of mind-body or exercise treatment,
- active cancer or receiving cancer treatment, and
- having received any steroid injections within past 3 months
- active infection,
- congestive heart failure,
- active blood clots,
- unexplained calf pain with concern for DVT,
- presence of an implanted pacemaker,
- pregnant or may be pregnant,
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- UT Southwestern Medical Center in the Allied Health Physical Therapy ClinicDallas, United StatesContact: Jason Zafereo, M.P.T, Ph.D.No longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Active LET groupTreatment being tested
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.
Treatment: Lymphatic Enhancement Technology (LET)
- Sham LET groupSham treatment, for comparison
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.
Treatment: Sham Lymphatic Enhancement Technology (LET)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia
- Plain-language title
- Lymphatic Enhancement Technology device for people with fibromyalgia, compared with a sham deviceGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07201818, who can take part
- Record updated
- 20 February 2026