Effects of Magnetic Tape on the Autonomic Nervous System

The effect of magnetic tape on pain and autonomic nervous system in subject with lower back pain.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Magnetic tape; Other: Placebo tape

Detailed Description

The effects of magnetic nanoparticles in tape applied in the lumbar spine on the autonomic nervous system measured with fully automated pupillometry and on pain in the spine measured with posterior to anterior pressure on the spinous process and the skin pinch test paravertebrally

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia De Alcántara, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current lower back pain with NPRS of 5
• Between ages 18-65

Exclusion Criteria:

• No lower back pain or pain <5 on the NPRS
• Not meeting age limit
• Having condition that prevents the PA procedure
• Conditions of the nervous system and inability keep eyes open

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Magnetic tape arm; Tape application bilaterally in the lumbar spine	Other: Magnetic tape; Tape with magnetic nanoparticles applied to the skin
SHAM_COMPARATOR: Placebo tape arm; Tape application bilaterally in the lumbar spine	Other: Placebo tape; Tape without nano particles applied to the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupillometry	1 minute continues pupil diameter measure	60 seconds measure preceding tape application. After outcome 5
Pupillometry	1 minute continues pupil diameter measure	Second 60 second measure immediate after tape application. After outcome 1
Pupillometry	1 minute continues pupil diameter measure	Third 60 measure 3 minutes after the tape is removed. After outcome 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PA spine	Anterior (PA) pressure on each spinal segment	First PA measure of 5 seconds on each PA of 5 seconds on each segment is starting off the measurement phase. This is the first outcome measure
Skin pinch test	Bilaterally of each vertebrae	3 seconds skin pinch test at each level starting immediately following the first PA measure. After Outcome 4
PA spine	Anterior (PA) pressure on each spinal segment	Five second measure of PA of 5 seconds each segment is taken immediately after the third pupillometry measure (tape removed). After outcome 3
Skin Pinch test	Bilaterally of each vertebrae	3 seconds skin pinch test at each level starting immediately following outcome 6

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University
• Collaborators: University of Valencia

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (ACTUAL): August 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: lower back pain; Autonomic nervous system; Pupillometry; Magnetic tape; magnetic nano particles; PA test; Skin pinch test
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 1240878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan in place

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No