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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946837
• Other study ID #: HSC-MS-23-0093
• Status: Completed
• Phase: Phase 1
• Start date: August 29, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Intervention

Drug:
• Indocyanine green (ICG) dye
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.

Device:
• NIRF-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
• Neuroglide 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Eva MedTech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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