NCT04836468

Brief Summary

A tape is applied over the lumbar 4th and lumbar 5th levels crosswise in people with low back pain. The possible variation of the arterial flow of the femoral artery is measured with ultrasound. A kinesiology tape was used as placebo tape and Magnetic Tape was used as experimental randomly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

1 month

First QC Date

April 5, 2021

Last Update Submit

January 27, 2022

Conditions

Low Back Pain

Keywords

magnetic tapePressurePainVascularUltrasound

Outcome Measures

Primary Outcomes (6)

  • peak systolic velocity (PSV)

    maximum systolic velocity of the femoral artery in (cm / s)

    1 minute

  • peak diastolic velocity (PDV)

    femoral artery peak diastolic velocity in (cm / s)

    1 minute

  • difference between systolic and diastolic (S / D)

    difference between systolic and diastolic in the femoral artery

    1 minute

  • pulsatility index (PI)

    assesses the peripheral resistance of blood vessels

    1 minute

  • resistance index (RI)

    reflects resistance to arterial flow

    1 minute

  • diameter

    diameter of each artery

    1 minute

Secondary Outcomes (1)

  • Algometria

    2 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

Application of Magnetic Tape transversely over the vertebral levels of L4 and L5

Diagnostic Test: Tape application

Placebo group

PLACEBO COMPARATOR

Application of kinesiology tape transversely over the vertebral levels of L4 and L5

Diagnostic Test: Tape application

Interventions

Tape applicationDIAGNOSTIC_TEST

Magnetic Tape or Kinesiology tape will be applied randomly with both the examiner and the subjects blinded.

Experimental groupPlacebo group

Eligibility Criteria

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

You may not qualify if:

  • not meeting the age requirement, having conditions that would be a contraindication to placing an adhesive bandage on the skin such as allergies, also being pregnant, having a pacemaker or people who have any contraindication of electromagnetic fields, neurological diseases or 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

Study Design

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

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 8, 2021

Study Start

June 28, 2021

Primary Completion

July 28, 2021

Study Completion

August 6, 2021

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)