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Completed

NCT Number: NCT05504369

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia de Alcántara, 46010, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic tape

Other

Tape with magnetic nanoparticles applied to the skin

Placebo tape

Other

Tape without nano particles applied to the skin

Primary outcomes

  1. Pupillometry

    Time frame: 60 seconds measure preceding tape application. After outcome 5

    1 minute continues pupil diameter measure

  2. Pupillometry

    Time frame: Second 60 second measure immediate after tape application. After outcome 1

    1 minute continues pupil diameter measure

  3. Pupillometry

    Time frame: Third 60 measure 3 minutes after the tape is removed. After outcome 2

    1 minute continues pupil diameter measure

Secondary outcomes

  1. PA spine

    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

    Anterior (PA) pressure on each spinal segment

  2. Skin pinch test

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

    Bilaterally of each vertebrae

  3. PA spine

    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

    Anterior (PA) pressure on each spinal segment

  4. Skin Pinch test

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

    Bilaterally of each vertebrae

Sponsors and collaborators

Lead sponsor

Florida Gulf Coast University

Other

Collaborators

  • University of Valencia

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2022
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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