NCT04845477

Brief Summary

A tape is applied over the inguinal skin nerves in people with low back pain. When placing the experimental tape, mobility should be improved and when the area is cooled with the tape, rotation should be limited again by inhibiting skin receptors. When returning to the initial temperature, you should improve the degrees of mobility again demonstrating that Magnetic tape only acts on the dermal receptors. The possible variation of the range in movement is measured with the validated program for the measurement of angles, Kinovea® program. A kinesiology tape was used as a placebo tape and the magnetic tape was used in a randomized experimental way.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2022

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 8, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 19, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

April 8, 2021

Last Update Submit

May 4, 2023

Conditions

Low Back Pain

Keywords

Magnetic tapeRange on motionColdCutaneous nervesHipKinovea® program

Outcome Measures

Primary Outcomes (2)

  • range on motion

    Maximum degrees of internal hip rotation measured with the Kinovea® program. Validated Video Program

    first assessment before placing the tapes. After placing one of the tape. After placing the other tape. After cooling the bandaged area with both tape. After recovery of local temperature.

  • Temperature

    an infrared thermometer will measure the temperature of the groin area in degrees centigrade

    first evaluation before placing the tapes. After cooling the bandaged area with both tapes. After recovery of local temperature.

Study Arms (3)

internal hip rotation pre measurement

NO INTERVENTION

with knee and hip flexion at 90º, internal hip rotation will be performed

internal hip rotation post experimental application measurement

EXPERIMENTAL

with Magnetic tape Application with knee and hip flexion at 90º, internal hip rotation will be performed

Device: Magnetic tape

internal hip rotation post placebo application measurement

PLACEBO COMPARATOR

with Placebo tape Application with knee and hip flexion at 90º, internal hip rotation will be performed

Device: Kinesiology tape

Interventions

Magnetic tapeDEVICE

magnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation

internal hip rotation post experimental application measurement
Kinesiology tapeDEVICE

kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation

internal hip rotation post placebo application measurement

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
  • People with 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 PainCommon Cold

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

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 8, 2021

First Posted

April 15, 2021

Study Start

September 19, 2022

Primary Completion

December 19, 2022

Study Completion

December 21, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)