LET for Fibromyalgia (NCT07201818) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
LET for Fibromyalgia
United States40 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pregnant,
* active cancer or receiving cancer treatment, and
* having received any steroid injections within past 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or pursue other treatment options in the meantime?
2The study is tracking changes in my fibromyalgia symptoms using something called the FIQR over just 4 to 8 weeks — is that long enough to know whether a treatment is truly helping someone with a condition like mine that tends to be long-term?
3This trial is listed as Phase NA, which I understand might mean it's studying something like a device, lifestyle intervention, or non-drug approach — can you tell me what LET actually is and whether it carries any known risks I should understand before considering it?
4Since the trial is measuring symptom changes starting as early as week 2, does that mean results could show up quickly, or is it more likely that 8 weeks is too short to see meaningful improvement in fibromyalgia?
5Are there established treatments for fibromyalgia — like medication, physical therapy, or cognitive behavioral therapy — that I should try first before considering an experimental study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline
Timeframe: Baseline, Week 2 pre-treatment
2
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 3 from baseline
Timeframe: Baseline, Week 3 pre-treatment
3
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 4 from baseline
Timeframe: Baseline, Week 4 pre-treatment
4
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 8 from baseline
Timeframe: Baseline, Week 8
Trial details
NCT IDNCT07201818
SponsorUniversity of Texas Southwestern Medical Center