LET for Fibromyalgia

This study is looking into whether a treatment called Lymphatic Enhancement Technology (LET) can help people with fibromyalgia. LET is a device that uses electricity to help with local circulation and muscle pain. Researchers will compare the active LET device to a sham (inactive) device. To join, you must be a woman between 18 and 65 years old, have been diagnosed with fibromyalgia, and have moderate to severe symptoms. The study will measure changes in your fibromyalgia symptoms using a questionnaire called FIQR over four weeks. The current status of this study is unclear, but it plans to enroll 40 participants.

Study design
This is a double-blinded, randomized study with 40 participants, comparing an active treatment to a sham treatment. Participants will be randomly assigned to receive either the active Lymphatic Enhancement Technology (LET) or a sham LET device.
What's involved
You will have four weekly treatment sessions, each lasting 45 minutes to 2 hours. You will also complete assessments of heart rate, blood pressure, pain thresholds, and quality-of-life surveys. The total study duration is two months.
Compensation
Not stated in the trial record.
Follow-up
You will receive a follow-up phone call or email from the study team four weeks after your last treatment.

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NCT07201818

LET for Fibromyalgia

Not Yet Recruiting
NAAges 18–65InterventionalTreatment
University of Texas Southwestern Medical Center
~40 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Lymphatic Enhancement Technology (LET)Sham Lymphatic Enhancement Technology (LET)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline
Measured over Baseline, Week 2 pre-treatment
+3 more outcomes measured
Fibromyalgia
1 sites across 1 states
Texas1
  • Jason Zafereo, M.P.T, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

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

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.
  • Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baselineBaseline, Week 2 pre-treatment

    The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

  • Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 3 from baselineBaseline, Week 3 pre-treatment

    The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

  • Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 4 from baselineBaseline, Week 4 pre-treatment

    The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

  • Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 8 from baselineBaseline, Week 8

    The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.