Effects of Magnetic Tape on the Autonomic Nervous System

NCT ID: NCT05504369

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-07-01

Brief Summary

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

Detailed Description

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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

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

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

Study Groups

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Magnetic tape arm

Tape application bilaterally in the lumbar spine

Group Type ACTIVE_COMPARATOR

Magnetic tape

Intervention Type OTHER

Tape with magnetic nanoparticles applied to the skin

Placebo tape arm

Tape application bilaterally in the lumbar spine

Group Type SHAM_COMPARATOR

Placebo tape

Intervention Type OTHER

Tape without nano particles applied to the skin

Interventions

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Magnetic tape

Tape with magnetic nanoparticles applied to the skin

Intervention Type OTHER

Placebo tape

Tape without nano particles applied to the skin

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role collaborator

Florida Gulf Coast University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rob Sillevis,

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Valencia

Valencia de Alcántara, , Spain

Site Status

Countries

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Spain

Other Identifiers

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1240878

Identifier Type: -

Identifier Source: org_study_id

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