FibromyalgiaNCT07201818
LET for Fibromyalgia
A study testing Lymphatic Enhancement Technology (LET) in people with Fibromyalgia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Lymphatic Enhancement Technology (LET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- pregnant or may be pregnant,
- active cancer or receiving cancer treatment, and
- having received any steroid injections within past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT Southwestern Medical Center in the Allied Health Physical Therapy Clinic
Dallas, Texas, 75390
Jason Zafereo, M.P.T, Ph.D., 214/648-1002, Jason.Zafereo@UTSouthwestern.edu
About this study
Official title: A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia
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.
Read the 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:
- Evaluate within- and between- group changes in severity and functional impact of fibromyalgia symptoms using the Fibromyalgia Impact Questionnaire-Revised (FIQR)
- Evaluate within- and between- group changes in quantitative sensory testing (QST) and autonomic cardiovascular testing (ACT).
- Correlate FIQR to QST and ACT values.
- Conditions
- Fibromyalgia
- Being tested
- Lymphatic Enhancement Technology (LET), Sham Lymphatic Enhancement Technology (LET)
- Keywords
- Lymphatic enhancement technology (LET), Chronic pain, Fibromyalgia, Autonomic Nervous System, Quantitative Sensory Testing
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Lymphatic Enhancement Technology (LET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: Baseline, Week 8
Secondary outcomes (15)
Change quantitative sensory testing (QST) as assessed by PPT immediately after treatment 1
A pressure pain threshold (PPT) PPT measurements will be taken with a hand-held Algomed algometer mounted with a 1-cm2 probe and calibrated in kilopascals. Pressure will be applied at a constant rate of 30 kPa/s to two different locations bilaterally:1) Upper trapezius muscle at midway point between the C7 spinous process and acromion; 2) Gluteal muscles at midway point between PSIS and greater trochanter. Three measurements will be taken at each site and averaged to determine the final value for that site. Measurements will be expressed in kPa with a range of 0-800. Lower scores indicate more severe impact.
Measured: Baseline, week 1 post treatment
Change in quantitative sensory testing (QST) as assessed by PPT immediately after treatment 4
A pressure pain threshold (PPT) PPT measurements will be taken with a hand-held Algomed algometer mounted with a 1-cm2 probe and calibrated in kilopascals. Pressure will be applied at a constant rate of 30 kPa/s to two different locations bilaterally:1) Upper trapezius muscle at midway point between the C7 spinous process and acromion; 2) Gluteal muscles at midway point between PSIS and greater trochanter. Three measurements will be taken at each site and averaged to determine the final value for that site. Measurements will be expressed in kPa with a range of 0-800. Lower scores indicate more severe impact.
Measured: 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
A pressure pain threshold (PPT) PPT measurements will be taken with a hand-held Algomed algometer mounted with a 1-cm2 probe and calibrated in kilopascals. Pressure will be applied at a constant rate of 30 kPa/s to two different locations bilaterally:1) Upper trapezius muscle at midway point between the C7 spinous process and acromion; 2) Gluteal muscles at midway point between PSIS and greater trochanter. Three measurements will be taken at each site and averaged to determine the final value for that site. Measurements will be expressed in kPa with a range of 0-800. Lower scores indicate more severe impact.
Measured: Baseline, week 4 post- treatment
Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 1
A pin prick stimulator will be used to assess for TS at the same testing sites used for PPT. Subjects will first be exposed to a single stimulus, and then to 10 repetitive stimuli with an inter-stimulus interval (ISI) of 1 second applied within an area 1cm in diameter. Participants will be asked to rate the level of pinprick pain intensity using a numeric pain rating from 0-10 for the single stimulus, and then for the peak pain of the train of 10 stimuli. Two rounds of testing will be performed, and an average of the values will be calculated to obtain a single value for the single stimulus and the peak stimulus of the train. The ratio of the peak stimulus of the train to the single stimulus pain score will be calculated and used for analysis. Scores range from 0-10. Higher scores indicate more severe impact. Subjects will also report whether any aftersensations are present at either 15 or 30 seconds after each of the two trials.
Measured: Baseline, week 1 post treatment
Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 4
A pin prick stimulator will be used to assess for TS at the same testing sites used for PPT. Subjects will first be exposed to a single stimulus, and then to 10 repetitive stimuli with an inter-stimulus interval (ISI) of 1 second applied within an area 1cm in diameter. Participants will be asked to rate the level of pinprick pain intensity using a numeric pain rating from 0-10 for the single stimulus, and then for the peak pain of the train of 10 stimuli. Two rounds of testing will be performed, and an average of the values will be calculated to obtain a single value for the single stimulus and the peak stimulus of the train. The ratio of the peak stimulus of the train to the single stimulus pain score will be calculated and used for analysis. Scores range from 0-10. Higher scores indicate more severe impact. Subjects will also report whether any aftersensations are present at either 15 or 30 seconds after each of the two trials.
Measured: Week 4 pre-treatment, week 4 post-treatment
Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick at week 4 post treatment from baseline
A pin prick stimulator will be used to assess for TS at the same testing sites used for PPT. Subjects will first be exposed to a single stimulus, and then to 10 repetitive stimuli with an inter-stimulus interval (ISI) of 1 second applied within an area 1cm in diameter. Participants will be asked to rate the level of pinprick pain intensity using a numeric pain rating from 0-10 for the single stimulus, and then for the peak pain of the train of 10 stimuli. Two rounds of testing will be performed, and an average of the values will be calculated to obtain a single value for the single stimulus and the peak stimulus of the train. The ratio of the peak stimulus of the train to the single stimulus pain score will be calculated and used for analysis. Scores range from 0-10. Higher scores indicate more severe impact. Subjects will also report whether any aftersensations are present at either 15 or 30 seconds after each of the two trials.
Measured: Baseline, week 4 post treatment
Change in quantitative sensory testing (QST) as assessed by CPM score immediately after treatment 1
Conditioned pain modulation (CPM) will be assessed via a PPT test stimulus applied to the upper trapezius for three trials. The average of the three PPT trials at the upper trapezius collected during the conditioning stimulus will be subtracted from the average of the three PPT trials collected before the CPT. Measurements of PPT will be expressed in kPa with a range of 0-800. Lower scores on CPM indicate more severe impact
Measured: Baseline, week 1 post treatment
Change in quantitative sensory testing (QST) as assessed by CPM score immediately after treatment 4
Conditioned pain modulation (CPM) will be assessed via a PPT test stimulus applied to the upper trapezius for three trials. The average of the three PPT trials at the upper trapezius collected during the conditioning stimulus will be subtracted from the average of the three PPT trials collected before the CPT. Measurements of PPT will be expressed in kPa with a range of 0-800. Lower scores on CPM indicate more severe impact
Measured: Week 4 pre treatment, week 4 post treatment
Change in quantitative sensory testing (QST) as assessed by CPM score at week 4 post treatment from baseline
Conditioned pain modulation (CPM) will be assessed via a PPT test stimulus applied to the upper trapezius for three trials. The average of the three PPT trials at the upper trapezius collected during the conditioning stimulus will be subtracted from the average of the three PPT trials collected before the CPT. Measurements of PPT will be expressed in kPa with a range of 0-800. Lower scores on CPM indicate more severe impact
Measured: Baseline, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) immediately after treatment 1
Autonomic cardiovascular function measures of interest will include heart rate collected during the two conditions (before and during CPT). Measurements of HR will be expressed in BPM with a range of 0-200. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the HR values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.
Measured: Baseline, week 1 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) immediately after treatment 4
Autonomic cardiovascular function measures of interest will include heart rate collected during the two conditions (before and during CPT). Measurements of HR will be expressed in BPM with a range of 0-200.Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the HR values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.
Measured: Week 4 pre treatment, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) at week 4 post treatment from baseline
Autonomic cardiovascular function measures of interest will include heart rate collected during the two conditions (before and during CPT). Measurements of HR will be expressed in BPM with a range of 0-200.Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the HR values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.
Measured: Baseline, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) immediately after treatment 1
Autonomic cardiovascular function measures of interest will include blood pressure collected during the two conditions (before and during CPT). Measurements of blood pressure will be expressed in mmHg with a range of 0-200 for systolic and diastolic. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the systolic and diastolic values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.
Measured: Baseline, week 1 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) immediately after treatment 4
Autonomic cardiovascular function measures of interest will include blood pressure collected during the two conditions (before and during CPT). Measurements of blood pressure will be expressed in mmHg with a range of 0-200 for systolic and diastolic. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the systolic and diastolic values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.
Measured: Week 4 pre treatment, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) at week 4 post treatment from baseline
Autonomic cardiovascular function measures of interest will include blood pressure collected during the two conditions (before and during CPT). Measurements of blood pressure will be expressed in mmHg with a range of 0-200 for systolic and diastolic. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the systolic and diastolic values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.
Measured: Baseline, week 4 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startJun 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arcturus Star Products
- Responsible party
- Principal investigator, Jason Zafereo, University of Texas Southwestern Medical Center
- Investigators
- Jason Zafereo, M.P.T, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201818
- Sponsor's protocol ID
- STU20251385
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia
- ClinicalTrials.gov ID
- NCT07201818
- Acronym / sponsor ID
- STU20251385
- Conditions
- Fibromyalgia
- Keywords
- Lymphatic enhancement technology (LET), Chronic pain, Fibromyalgia, Autonomic Nervous System, Quantitative Sensory Testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Arcturus Star Products
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate within- and between- group changes in severity and functional impact of fibromyalgia symptoms using the Fibromyalgia Impact Questionnaire-Revised (FIQR)
- Evaluate within- and between- group changes in quantitative sensory testing (QST) and autonomic cardiovascular testing (ACT).
- Correlate FIQR to QST and ACT values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active LET group | Experimental | Device: Lymphatic Enhancement Technology (LET)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. |
| Sham LET group | Sham comparator | Device: Sham Lymphatic Enhancement Technology (LET)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active LET group |
| 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. | Device | Sham LET group |
Primary outcome
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline
Time frame: Baseline, Week 2 pre-treatment
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'.
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 3 from baseline
Time frame: Baseline, Week 3 pre-treatment
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'.
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 4 from baseline
Time frame: Baseline, Week 4 pre-treatment
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'.
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 8 from baseline
Time frame: Baseline, Week 8
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'.
15 secondary outcomes
Change quantitative sensory testing (QST) as assessed by PPT immediately after treatment 1
Time frame: Baseline, week 1 post treatment
Change in quantitative sensory testing (QST) as assessed by PPT immediately after treatment 4
Time frame: 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
Time frame: Baseline, week 4 post- treatment
Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 1
Time frame: Baseline, week 1 post treatment
Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 4
Time frame: Week 4 pre-treatment, week 4 post-treatment
Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick at week 4 post treatment from baseline
Time frame: Baseline, week 4 post treatment
Change in quantitative sensory testing (QST) as assessed by CPM score immediately after treatment 1
Time frame: Baseline, week 1 post treatment
Change in quantitative sensory testing (QST) as assessed by CPM score immediately after treatment 4
Time frame: Week 4 pre treatment, week 4 post treatment
Change in quantitative sensory testing (QST) as assessed by CPM score at week 4 post treatment from baseline
Time frame: Baseline, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) immediately after treatment 1
Time frame: Baseline, week 1 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) immediately after treatment 4
Time frame: Week 4 pre treatment, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) at week 4 post treatment from baseline
Time frame: Baseline, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) immediately after treatment 1
Time frame: Baseline, week 1 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) immediately after treatment 4
Time frame: Week 4 pre treatment, week 4 post treatment
Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) at week 4 post treatment from baseline
Time frame: Baseline, week 4 post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Fibromyalgia
Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruiting
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Fibromyalgia
Enrolling by invitation
Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation
Arthritis, Fibromyalgia
Recruiting
Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia
Fibromyalgia (FM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Zafereo, M.P.T, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic Enhancement Technology (LET) in people with Fibromyalgia, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Zafereo, M.P.T, Ph.D. (214/648-1002, Jason.Zafereo@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline (time frame: Baseline, Week 2 pre-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.