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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
LET for Fibromyalgia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jason Zafereo, M.P.T, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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'.