Lymphatic Enhancement Technology for Fibromyalgia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Lymphatic Enhancement Technology (LET) for individuals with fibromyalgia, a condition causing widespread pain and fatigue. The trial aims to determine if LET can reduce symptoms by using a machine that emits lights, sounds, and energy. Participants will receive either the actual LET treatment or a sham (fake) treatment for comparison. Women who meet the criteria for fibromyalgia and have not previously tried LET may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for fibromyalgia.
Do I need to stop taking my current medications for the trial?
You don't need to stop your current medications, but you must not change them within 14 days before starting the study or during the study.
What prior data suggests that Lymphatic Enhancement Technology is safe for fibromyalgia patients?
Research has shown that Lymphatic Enhancement Technology (LET) is generally safe. The FDA has approved LET for certain uses, indicating it has passed some safety checks.
Other studies have found that treatments similar to LET, such as gentle massage for fibromyalgia, are well-tolerated. These studies reported no major side effects, and patients managed the treatment without significant issues.
Although detailed safety data for LET in fibromyalgia is limited, the existing approval and related studies suggest LET is likely a safe option for those considering joining clinical trials.12345Why are researchers excited about this trial?
Researchers are excited about Lymphatic Enhancement Technology (LET) for fibromyalgia because it introduces a unique approach by using a machine that emits lights, sounds, and electrostatic energy. Unlike standard treatments like medications or physical therapy, LET combines sensory stimulation with electrostatic energy, potentially enhancing lymphatic function and reducing symptoms. This innovative method could offer relief faster and with fewer side effects, providing a new hope for those struggling with fibromyalgia.
What evidence suggests that Lymphatic Enhancement Technology is effective for fibromyalgia?
Research shows that treatments targeting the lymphatic system can help alleviate fibromyalgia symptoms. Studies on manual lymphatic drainage (MLD), similar to Lymphatic Enhancement Technology (LET), have shown positive results. Specifically, MLD has reduced pain and improved the quality of life for people with fibromyalgia. In this trial, participants in the active LET group will receive treatment with a machine designed to boost lymphatic function, potentially offering similar benefits. Early findings suggest that LET may decrease pain and enhance overall well-being for those with fibromyalgia.13678
Who Is on the Research Team?
Jason Zafereo, M.P.T, Ph.D.
Principal Investigator
UT Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for women aged 18-65 with moderate to severe fibromyalgia, as indicated by an FIQ score ≥39. Participants must meet the American College of Rheumatology's criteria for fibromyalgia and not have changed medications in the last 14 days. They cannot have had LET treatment before or be undergoing other mind-body treatments, and should not have a pacemaker, active blood clots, infections, heart failure, cancer treatments or recent steroid injections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline assessments including demographic information and medical history
Treatment
Participants receive four weekly treatments with either active or sham LET device
Follow-up
A follow-up phone call or email from the study team to assess outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Lymphatic Enhancement Technology (LET)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Arcturus Star Products
Collaborator