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

The University of Texas System (UT)

Status and phase

Completed

Phase 1

Conditions

Back Pain

Neck Pain

Treatments

Device: NIRF-LI imaging

Device: Neuroglide pad

Drug: Indocyanine green (ICG) dye

Study type

Interventional

Funder types

Other

Identifiers

NCT05946837

HSC-MS-23-0093

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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