Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device

Study Overview
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Brief Summary
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The purpose of this study is to objectively assess lymphatic function before, during, and immediately after Neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any VAS (Visual Analog Scale, a commonly used measure of pain perception) score change after Neuroglide treatment.

Official Title
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Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device

Conditions
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Neck Pain, Back Pain

Intervention / Treatment
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* Drug: Indocyanine green (ICG) dye
* Device: NIRF-LI imaging
* Device: Neuroglide pad


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ambulatory and possess all four limbs Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study Weight less than 400 lbs Exclusion Criteria: Women who are pregnant or breast-feeding Persons who are allergic to iodine or indocyanine green Heart failure, poorly controlled kidney disease (glomerular filtration rate <30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism Any circumstance where increased lymphatic or venous return is undesirable

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumatic Compression Therapy (PCT)<br> | Drug: Indocyanine green (ICG) dye<br>* ICG (25 mg vial) will be reconstituted with 10 ml sterile water provided by the manufacturer; further dilutions will be made in sterile saline just prior to administration. The final concentration of 0.32 millimolar (mM) will provide 25 μg ICG/injection, with each injection of 0.1 cc to be made . Up to 30 intradermal injections using conventional 30- or 31-gauge needles will be administered to each subject, for a maximum dose of 750 ug ICG, over 200 times less than the maximum allowed dose. Injection sites will be cleaned with alcohol wipes before intradermal injection.<br>Device: NIRF-LI imaging<br>* Near-infrared fluorescence lymphatic imaging (NIRF-LI) imaging will be done to assess the drainage of ICG laden lymph from ICG injection sites toward regional nodal basins for 60 minutes before, during and after the Neuroglide pad treatment<br>Device: Neuroglide pad<br>* After injection of Indocyanine green (ICG) dye and NIRF-LI imaging the subject will lie on the Neuroglide pad for the one-hour PCT treatment session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged |  | Baseline, during Neuroglide treatment ( 1 hour after NIRF-LI imaging ), 1 hour after PCT treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain as assessed by the Visual Analog Scale (VAS) | This is scored from 1(no pain)-10( worst pain possible) a higher number indicating more pain | Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion |