LET for Fibromyalgia

NCT07201818 | Not Yet Recruiting FDA Device

• 1 other identifier: STU20251385
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline

  The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

  Baseline, Week 2 pre-treatment

• Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 3 from baseline

  The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

  Baseline, Week 3 pre-treatment

• Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 4 from baseline

  The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

  Baseline, Week 4 pre-treatment

• Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 8 from baseline

  The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

  Baseline, Week 8

Secondary Outcomes (15)

• Change quantitative sensory testing (QST) as assessed by PPT immediately after treatment 1

  Baseline, week 1 post treatment

• Change in quantitative sensory testing (QST) as assessed by PPT immediately after treatment 4

  Week 4 pre-treatment, week 4 post-treatment

• Change in quantitative sensory testing (QST) as assessed by PPT at week 4 post treatment from baseline

  Baseline, week 4 post- treatment

• Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 1

  Baseline, week 1 post treatment

• Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 4

  Week 4 pre-treatment, week 4 post-treatment

Other Outcomes (10)

• Assessment of blinding fidelity immediately after treatment 1

  Week 1 post treatment

• Assessment of blinding fidelity at week 4 post treatment

  Week 4 post treatment

• Treatment effect as assessed by change in pain intensity immediately after treatment 1

  Baseline, week 1 post treatment]

Study Arms (2)

Active LET group

EXPERIMENTAL

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.

Device: Lymphatic Enhancement Technology (LET)

Sham LET group

SHAM COMPARATOR

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.

Device: Sham Lymphatic Enhancement Technology (LET)

Interventions

Lymphatic Enhancement Technology (LET) 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.

Active LET group

Sham Lymphatic Enhancement Technology (LET) 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.

Sham LET group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Arcturus Star Products: collaborator

Study Sites (1)

UT Southwestern Medical Center in the Allied Health Physical Therapy Clinic

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Zafereo, M.P.T, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

214/648-1002; Jason.Zafereo@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will not know whether they are receiving the real or placebo treatment, but the researchers performing the treatment will know.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: When it is determined that subjects are eligible for the study, the participants will be assigned by chance (like flipping a coin) to one of 2 study groups. Group 1 will receive active/real LET treatment, while group 2 will receive placebo/sham LET treatment.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: The data will be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. This data will be available for individual participant data meta-analysis. To gain access, data requestors will need to sign a data access agreement. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Inquiries must be directed to Jason.Zafereo@UTSouthwestern.edu for requests for Information regarding submitting proposals and accessing data.

Locations

US (1)