Effects of Magnetic Tape on the Autonomic Nervous System

Study Overview
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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

Official Title
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Effects of Magnetic Tape on the Autonomic Nervous System

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Magnetic tape
* Other: Placebo tape


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single group design with random allocation of intervention placebo versus treatment tape. Next day other intervention was used
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnetic tape arm<br>Tape application bilaterally in the lumbar spine | Other: Magnetic tape<br>* Tape with magnetic nanoparticles applied to the skin<br>|
| Sham Comparator: Placebo tape arm<br>Tape application bilaterally in the lumbar spine | Other: Placebo tape<br>* Tape without nano particles applied to the skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PA spine | Anterior (PA) pressure on each spinal segment | 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 | Bilaterally of each vertebrae | 3 seconds skin pinch test at each level starting immediately following the first PA measure. After Outcome 4 | 
| PA spine | Anterior (PA) pressure on each spinal segment | 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 | Bilaterally of each vertebrae | 3 seconds skin pinch test at each level starting immediately following outcome 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic tape, magnetic nano particles, Pupillometry, Autonomic nervous system, lower back pain, PA test, Skin pinch test