LET for Fibromyalgia

NCT ID: NCT07201818

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

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 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.

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), past/current medical history, and current medications. The primary outcome measure of severity and functional impact of fibromyalgia symptoms will be collected using the Fibromyalgia Impact Questionnaire Revised (FIQR) at baseline, at each of the four treatment sessions, and one month after the last treatment. The following secondary outcome measures will be collected at baseline, immediately after the first treatment session, and before and after the fourth treatment session: 1. Pressure pain threshold (PPT), 2. temporal summation (TS) to pin prick, and 3. Autonomic cardiovascular function and conditioned pain modulation (CPM) during cold pressor test (CPT). Thirty-six participants will be randomized at the baseline testing session to receive 4 weekly treatments of active (n=18) or sham (n=18) LET. Opaque, sealed envelopes containing equal quantities of the number "1" or "2" will be placed into a container. On the first day of the study, participants will select an envelope that will only be opened by the treating clinician. The number "1" will designate participants to the active LET group, with the number "2" designating to the sham LET group. The treating clinician will record the participant's group assignment in order to administer the correct treatment throughout the study. The Aria LET Elite Instrument (Arcturus Star, Cortez, Colorado) will be utilized for the intervention and sham groups. The active device has two treatment wands that emit electrostatic energy, and give off a perceptible light and sound when they come in contact with the skin of the participant. The sham LET device used for the control group will also use two wands that emit a light and sound similar to the active LET device, but will not emit electrostatic energy waves. The device intensity ranges from 0-10 units which correlates to an amplitude of 12.9-38.25 microamps. Frequency ranges from 0-1000 units with a nonlinear correlation between 41-260 Hz. In the active treatment group, for session 1, the machine's intensity will be set to 3 units and a frequency of 300 units. For treatment session 2, the intensity and frequency will increase as tolerated to 4 units and 400 units, respectively. For treatment session 3, the intensity and frequency will increase as tolerated to 5 units and 500 units, respectively. For treatment session 4, the intensity and frequency will increase as tolerated to 6 units and 600 units, respectively. In the unlikely event that participants report an increase in fibromyalgia-related symptoms for more than two days after a treatment session, the treating clinicians will maintain (not increase) the intensity and frequency settings between visits. The treatment will utilize both wands contacting the skin of the participant and will progress in this treatment landmark order: terminus, jugulodigastric, parotid glands/sinuses, axilla, abdominal region, inguinal, lower/upper back. The clinicians will spend about 3 minutes on each landmark, spending more time in areas that exhibit more soft tissue resistance (detected through the wand), but staying within a total treatment time of 25 minutes. The control group will receive treatment using the same parameters, landmark progression, and treatment time on the sham device. All treatment parameters and participants' responses to treatment (treatment effect) will be documented at each visit. Additional measures will include a Blinding Fidelity Question administered at the end of the first and fourth treatment visit.

Using fibromyalgia as a target condition, the following aims will be tested:

1. Evaluate within- and between- group changes in severity and functional impact of fibromyalgia symptoms using the Fibromyalgia Impact Questionnaire-Revised (FIQR)

2. Evaluate within- and between- group changes in quantitative sensory testing (QST) and autonomic cardiovascular testing (ACT).

3. Correlate FIQR to QST and ACT values.

Conditions

Fibromyalgia

Keywords

Lymphatic enhancement technology (LET); Chronic pain; Fibromyalgia; Autonomic Nervous System; Quantitative Sensory Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active LET 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.

Group Type: EXPERIMENTAL

Lymphatic Enhancement Technology (LET)

Intervention Type: 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 LET group

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.

Group Type: SHAM_COMPARATOR

Sham Lymphatic Enhancement Technology (LET)

Intervention Type: 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.

Interventions

Lymphatic Enhancement Technology (LET)

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.

Intervention Type: DEVICE

Sham Lymphatic Enhancement Technology (LET)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arcturus Star Products

UNKNOWN

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jason Zafereo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Zafereo, M.P.T, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center in the Allied Health Physical Therapy Clinic

Dallas, Texas, United States

Countries

United States

Central Contacts

Jason Zafereo, M.P.T, Ph.D.

Role: CONTACT

Phone: 214/648-1002

Email: Jason.Zafereo@UTSouthwestern.edu

Facility Contacts

Jason Zafereo, M.P.T, Ph.D.

Role: primary

Other Identifiers

STU20251385

Identifier Type: -

Identifier Source: org_study_id