Effects of Magnetic Tape on the Autonomic Nervous System

Low Back Pain Clinical Trial

Official title:

Effects of Magnetic Tape on the Autonomic Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504369
• Other study ID #: 1240878
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2022
• Source: Florida Gulf Coast University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Magnetic tape
Tape with magnetic nanoparticles applied to the skin
• Placebo tape
Tape without nano particles applied to the skin

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia De Alcántara

Sponsors (2)

Lead Sponsor	Collaborator
Florida Gulf Coast University	University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupillometry	1 minute continues pupil diameter measure	60 seconds measure preceding tape application. After outcome 5
Primary	Pupillometry	1 minute continues pupil diameter measure	Second 60 second measure immediate after tape application. After outcome 1
Primary	Pupillometry	1 minute continues pupil diameter measure	Third 60 measure 3 minutes after the tape is removed. After outcome 2
Secondary	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
Secondary	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
Secondary	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
Secondary	Skin Pinch test	Bilaterally of each vertebrae	3 seconds skin pinch test at each level starting immediately following outcome 6