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Effects of Magnetic Tape on the Autonomic Nervous System

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Magnetic tape
Placebo tape
Sponsored by
Florida Gulf Coast University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain focused on measuring Magnetic tape, magnetic nano particles, Pupillometry, Autonomic nervous system, lower back pain, PA test, Skin pinch test

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Magnetic tape arm

Placebo tape arm

Arm Description

Tape application bilaterally in the lumbar spine

Tape application bilaterally in the lumbar spine

Outcomes

Primary Outcome Measures

Pupillometry
1 minute continues pupil diameter measure
Pupillometry
1 minute continues pupil diameter measure
Pupillometry
1 minute continues pupil diameter measure

Secondary Outcome Measures

PA spine
Anterior (PA) pressure on each spinal segment
Skin pinch test
Bilaterally of each vertebrae
PA spine
Anterior (PA) pressure on each spinal segment
Skin Pinch test
Bilaterally of each vertebrae

Full Information

First Posted
August 10, 2022
Last Updated
August 16, 2022
Sponsor
Florida Gulf Coast University
Collaborators
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05504369
Brief Title
Effects of Magnetic Tape on the Autonomic Nervous System
Official Title
Effects of Magnetic Tape on the Autonomic Nervous System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida Gulf Coast University
Collaborators
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Magnetic tape, magnetic nano particles, Pupillometry, Autonomic nervous system, lower back pain, PA test, Skin pinch test

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group design with random allocation of intervention placebo versus treatment tape. Next day other intervention was used
Masking
ParticipantInvestigator
Masking Description
Participant and researchers where not aware of the magnetic tape versus placebo tape as the look and feel identical
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic tape arm
Arm Type
Active Comparator
Arm Description
Tape application bilaterally in the lumbar spine
Arm Title
Placebo tape arm
Arm Type
Sham Comparator
Arm Description
Tape application bilaterally in the lumbar spine
Intervention Type
Other
Intervention Name(s)
Magnetic tape
Intervention Description
Tape with magnetic nanoparticles applied to the skin
Intervention Type
Other
Intervention Name(s)
Placebo tape
Intervention Description
Tape without nano particles applied to the skin
Primary Outcome Measure Information:
Title
Pupillometry
Description
1 minute continues pupil diameter measure
Time Frame
60 seconds measure preceding tape application. After outcome 5
Title
Pupillometry
Description
1 minute continues pupil diameter measure
Time Frame
Second 60 second measure immediate after tape application. After outcome 1
Title
Pupillometry
Description
1 minute continues pupil diameter measure
Time Frame
Third 60 measure 3 minutes after the tape is removed. After outcome 2
Secondary Outcome Measure Information:
Title
PA spine
Description
Anterior (PA) pressure on each spinal segment
Time Frame
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
Title
Skin pinch test
Description
Bilaterally of each vertebrae
Time Frame
3 seconds skin pinch test at each level starting immediately following the first PA measure. After Outcome 4
Title
PA spine
Description
Anterior (PA) pressure on each spinal segment
Time Frame
Five second measure of PA of 5 seconds each segment is taken immediately after the third pupillometry measure (tape removed). After outcome 3
Title
Skin Pinch test
Description
Bilaterally of each vertebrae
Time Frame
3 seconds skin pinch test at each level starting immediately following outcome 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Valencia
City
Valencia De Alcántara
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan in place

Learn more about this trial

Effects of Magnetic Tape on the Autonomic Nervous System

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