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A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia
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.
Details
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 40 |
| Start date | 2026-06 |
| Completion | 2028-01 |
Conditions
- Fibromyalgia
Interventions
- Lymphatic Enhancement Technology (LET)
- Sham Lymphatic Enhancement Technology (LET)
Primary outcomes
- Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline — Baseline, 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 baseline — Baseline, 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 baseline — Baseline, 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 baseline — Baseline, 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'.
Countries
United States