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
University of Texas 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)
Trial Overview
The study tests Lymphatic Enhancement Technology (LET) against a sham procedure to see if it helps with fibromyalgia symptoms. It's double-blinded so neither participants nor researchers know who gets real vs sham treatment. Participants receive weekly sessions over one month and complete quality-of-life surveys with follow-up after four weeks post-treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants in the active/real LET group will be treated with a machine that emits lights, sounds, and electrostatic energy. Three additional treatments will be administered over three weeks.
Participants in the placebo/sham LET group will be treated with a machine that emits lights and sounds, but no electrostatic energy. Three additional treatments will be administered over three weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Arcturus Star Products
Collaborator
Citations
Study Details | NCT07201818 | LET for Fibromyalgia
The purpose of this research study is to determine the effectiveness of Lymphatic Enhancement Technology (LET) treatment in patients with ...
Lymphatic Enhancement Technology for Fibromyalgia
The purpose of this research study is to determine the effectiveness of Lymphatic Enhancement Technology (LET) treatment in patients with fibromyalgia.
Effectiveness of manual lymphatic drainage in women with ...
To analyse the efficacy of manual lymphatic drainage (MLD) as an alternative to traditional treatment of fibromyalgia (FM) in women.
Effects of manual lymphatic drainage on pain intensity ...
This study aimed to investigate the effectiveness of Manual Lymphatic Drainage (MLD) on the pain intensity, impact of the disease, and health-related quality ...
Effectiveness of manual lymphatic drainage in women with ...
To analyse the efficacy of manual lymphatic drainage (MLD) as an alternative to traditional treatment of fibromyalgia (FM) in women. Methods. This was an ...
Whole-Body Photobiomodulation Therapy for Fibromyalgia
Safety data were based on clinical symptoms and physiological variables. Trial duration spanned four seasons; hence, weather as a variable could not be ...
Safety and Effectiveness of Vibration Massage by Deep ...
In conclusion, deep oscillation massage is safe and well tolerated in patients with FMS and might improve symptoms and quality of life rather ...
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researchgate.net
researchgate.net/publication/244878866_Manual_lymph_drainage_therapy_using_light_massage_for_fibromyalgia_sufferers_A_pilot_studyManual lymph drainage therapy using light massage for ...
Manual lymph drainage therapy using light massage for fibromyalgia sufferers: A pilot study ... Our data indicate that the oxytocinergic system ...
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