Effects of Magnetic Tape on the Autonomic Nervous System

NCT05504369 | Completed

• 1 other identifier: 1240878
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

Magnetic tape; magnetic nano particles; Pupillometry; Autonomic nervous system; lower back pain; PA test; Skin pinch test

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• Skin pinch test

  3 seconds skin pinch test at each level starting immediately following the first PA measure. After Outcome 4

• 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

• Skin Pinch test

  3 seconds skin pinch test at each level starting immediately following outcome 6

Study Arms (2)

Magnetic tape arm

ACTIVE COMPARATOR

Tape application bilaterally in the lumbar spine

Other: Magnetic tape

Placebo tape arm

SHAM COMPARATOR

Tape application bilaterally in the lumbar spine

Other: Placebo tape

Interventions

Magnetic tape OTHER

Tape with magnetic nanoparticles applied to the skin

Magnetic tape arm

Placebo tape OTHER

Tape without nano particles applied to the skin

Placebo tape arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Gulf Coast University: lead
• University of Valencia: collaborator

Study Sites (1)

University of Valencia

Valencia de Alcántara, 46010, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and researchers where not aware of the magnetic tape versus placebo tape as the look and feel identical
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 17, 2022
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)