What this study is
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.
What's being tested
- Lymphatic Enhancement Technology (LET)
Intervention · DEVICE
Lymphatic Enhancement Technology (LET) is an FDA-approved electrotherapeutic modality, with indications for addressing local lymphatic and vascular circulation as well as muscle pain and spasm. The Aria LET Elite Instrument (Arcturus Star, Cortez, Colorado) will be utilized for the intervention group.
- Sham Lymphatic Enhancement Technology (LET)
Intervention · DEVICE
A separate modified Aria Elite LET Instrument (Arcturus Star, Cortez, Colorado) will be utilized for the sham group. The sham LET device used for the control group will emit a light and sound similar to the true LET device, but will not emit energy waves.
Study details
- Official title
- A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia
- Sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Fibromyalgia
- Enrolling
- 40 people
- Starts
- 2026-01
- Est. completion
- 2027-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUT Southwestern Medical Center in the Allied Health Physical Therapy Clinic
Dallas, Texas, United States
- Jason Zafereo, M.P.T, Ph.D. · Contact214/648-1002Jason.Zafereo@UTSouthwestern.edu
Study team
Sponsor
University of Texas Southwestern Medical Center
Study ID STU20251385
Principal investigator
Jason Zafereo, M.P.T, Ph.D.
University of Texas Southwestern Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.