Status:
NOT_YET_RECRUITING
LET for Fibromyalgia
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Arcturus Star Products
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
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 effectivenes...
Detailed Description
At enrollment, participants will complete a baseline assessment including collection of demographic information (age, race/ethnicity, BMI, employment status, duration of symptoms, smoking history), pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07201818
Start Date
January 1 2026
End Date
January 1 2027
Last Update
December 18 2025
Active Locations (1)
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1
UT Southwestern Medical Center in the Allied Health Physical Therapy Clinic
Dallas, Texas, United States, 75390