NCT04873726

Brief Summary

The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension. Possible variation in the autonomic nervous system is assessed in the reaction of the pupils. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

April 26, 2021

Last Update Submit

September 13, 2022

Conditions

Low Back Pain

Keywords

low back painpupilMagnetic tape®pinchVorteq® systemautonomic nervous systempainalgometer

Outcome Measures

Primary Outcomes (3)

  • Pressure

    pressure in each spinous process

    Changes from pressure on spinous processes, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape

  • Pupil reaction

    the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc)

    Changes from pupil diameter, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape

  • Pinch test

    press the paravertebral skin at each level of the spine with the first three fingers

    Changes from paravertebral pinch test, first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape

Study Arms (9)

Pre: pain AP

NO INTERVENTION

Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure

Pre: pain Pinch test

NO INTERVENTION

perceived pain over the paravertebral skin at each level of the spine using Pinch test

Pre: pupil diameter

NO INTERVENTION

the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.

Post Exp: pain AP

EXPERIMENTAL

Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure

Device: Magnetic Tape® aplication

Post Exp: pain Pinch test

EXPERIMENTAL

perceived pain over the paravertebral skin at each level of the spine using Pinch test

Device: Magnetic Tape® aplication

Post Exp: pupil diameter

EXPERIMENTAL

the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.

Device: Magnetic Tape® aplication

Post Pla: pain AP

PLACEBO COMPARATOR

Pain assessment in the spinous processes of the spine with algometer anteroposterior pressure

Device: Kinesiology Tape

Post Pla: pain Pinch test

PLACEBO COMPARATOR

perceived pain over the paravertebral skin at each level of the spine using Pinch test

Device: Kinesiology Tape

Post Pla: pupil diameter

PLACEBO COMPARATOR

the pupil responses were measured with the fully automated Vorteq® system (Micromedical Technologies, Inc) to record the pupil reaction.

Device: Kinesiology Tape

Interventions

Magnetic Tape® aplicationDEVICE

Magnetic tape® is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size

Post Exp: pain APPost Exp: pain Pinch testPost Exp: pupil diameter
Kinesiology TapeDEVICE

Kinesiology tape is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size

Post Pla: pain APPost Pla: pain Pinch testPost Pla: pupil diameter

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with low back pain.
  • Subjects aged 18-65 years.

You may not qualify if:

  • Tape allergies
  • Adhesive allergies
  • Pregnant
  • People with pacemakers
  • People who have any contraindication of electromagnetic fields
  • Peoplewith neurological diseases
  • Taking any medication that may interact with magnetic fields.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Francisco Selva

Valencia, 46008, Spain

Location

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 5, 2021

Study Start

July 22, 2022

Primary Completion

December 22, 2022

Study Completion

December 30, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)