Effects of Magnetic Tape on the Autonomic Nervous System

Sponsor

Florida Gulf Coast University (Other)

Overall Status

Completed

CT.gov ID

NCT05504369

Collaborator

University of Valencia (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Magnetic tape Other: Placebo tape	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single group design with random allocation of intervention placebo versus treatment tape. Next day other intervention was usedSingle group design with random allocation of intervention placebo versus treatment tape. Next day other intervention was used

Masking:

Double (Participant, Investigator)

Masking Description:

Participant and researchers where not aware of the magnetic tape versus placebo tape as the look and feel identical

Primary Purpose:

Basic Science

Official Title:

Effects of Magnetic Tape on the Autonomic Nervous System

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pupillometry [60 seconds measure preceding tape application. After outcome 5]
1 minute continues pupil diameter measure
Pupillometry [Second 60 second measure immediate after tape application. After outcome 1]
1 minute continues pupil diameter measure
Pupillometry [Third 60 measure 3 minutes after the tape is removed. After outcome 2]
1 minute continues pupil diameter measure

Secondary Outcome Measures

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