Back Pain, Neck Pain
Conditions
Brief summary
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.
Interventions
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.
DEVICENIRF-LI imaging
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
DEVICENeuroglide pad
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.
Sponsors
Eva MedTech, Inc.
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain as assessed by the Visual Analog Scale (VAS) | Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion | This is scored from 1(no pain)-10( worst pain possible) a higher number indicating more pain |
Countries
United States
Outcome results
None listed