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

Phase 1

Completed

• Conditions: Neck Pain; Back Pain
• Interventions: Drug: Indocyanine green (ICG) dye; Device: NIRF-LI imaging; Device: Neuroglide pad

• Registration Number: NCT05946837
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-14
• Study Start: 2023-08-29
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pneumatic Compression Therapy (PCT)	NIRF-LI imaging	-
Pneumatic Compression Therapy (PCT)	Indocyanine green (ICG) dye	-
Pneumatic Compression Therapy (PCT)	Neuroglide pad	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States