NCT04875273

Brief Summary

The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension. The possible variation in perceived pain in each spinous process is measured with the Wagner Force Dial-FDK 20 algometer. The possible variation in the range of motion in ankle dorsiflexion is measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System. 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
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

April 26, 2021

Last Update Submit

September 13, 2022

Conditions

Keywords

painmagnetic tapealgometerlow back painleg motionMobilityRange of motion

Outcome Measures

Primary Outcomes (2)

  • Pressure

    pressure with 1kg, 2kg, 3kg and the maximum pressure in each spinous process.

    Changes in pain when applying pressure on the spinous processes, first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape. It will wait at least one minute to repeat the test.

  • Range of motion

    Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise

    Assessment System

Study Arms (18)

Pre: pain assessment in the spinous processes of the spine with 1kg

NO INTERVENTION

press on the spinous processes with the algometer perpendicularly.

Pre: pain assessment in the spinous processes of the spine with 2 kg

NO INTERVENTION

press on the spinous processes with the algometer perpendicularly.

Pre: pain assessment in the spinous processes of the spine with 3 kg

NO INTERVENTION

press on the spinous processes with the algometer perpendicularly.

Pre: pain assessment in the spinous processes of the spine with maximum pressure

NO INTERVENTION

press on the spinous processes with the algometer perpendicularly.

Post Exp: pain assessment in the spinous processes of the spine with 1kg

EXPERIMENTAL

press on the spinous processes with the algometer perpendicularly.

Device: Magnetic Tape® aplicación

Post Exp: pain assessment in the spinous processes of the spine with 2kg

EXPERIMENTAL

press on the spinous processes with the algometer perpendicularly.

Device: Magnetic Tape® aplicación

Post Exp: pain assessment in the spinous processes of the spine with 3kg

EXPERIMENTAL

press on the spinous processes with the algometer perpendicularly.

Device: Magnetic Tape® aplicación

Post Exp: pain assessment in the spinous processes of the spine with maximum pressure

EXPERIMENTAL

press on the spinous processes with the algometer perpendicularly.

Device: Magnetic Tape® aplicación

Post Pla: pain assessment in the spinous processes of the spine with 1kg

PLACEBO COMPARATOR

press on the spinous processes with the algometer perpendicularly.

Device: Kinesiology Tape application

Post Pla: pain assessment in the spinous processes of the spine with 2kg

PLACEBO COMPARATOR

press on the spinous processes with the algometer perpendicularly.

Device: Kinesiology Tape application

Post Pla: pain assessment in the spinous processes of the spine with 3kg

PLACEBO COMPARATOR

press on the spinous processes with the algometer perpendicularly.

Device: Kinesiology Tape application

Post Pla: pain assessment in the spinous processes of the spine with maximum pressure

PLACEBO COMPARATOR

press on the spinous processes with the algometer perpendicularly.

Device: Kinesiology Tape application

Pre: Right Ankle Dorsiflexion

NO INTERVENTION

Range of motion in right ankle dorsiflexion is measured with LegMOtion®

Post Pla: Right Ankle Dorsiflexion

PLACEBO COMPARATOR

Range of motion in right ankle dorsiflexion is measured with LegMOtion®

Device: Kinesiology Tape application

Post Exp: Right Ankle Dorsiflexion

EXPERIMENTAL

Range of motion in right ankle dorsiflexion is measured with LegMOtion®

Device: Magnetic Tape® aplicación

Pre: Left Ankle Dorsiflexion

NO INTERVENTION

Range of motion in left ankle dorsiflexion is measured with LegMOtion®

Post Pla: Left Ankle Dorsiflexion

PLACEBO COMPARATOR

Range of motion in left ankle dorsiflexion is measured with LegMOtion®

Device: Kinesiology Tape application

Post Exp: Left Ankle Dorsiflexion

EXPERIMENTAL

Range of motion in left ankle dorsiflexion is measured with LegMOtion®

Device: Magnetic Tape® aplicación

Interventions

Magnetic tape® is applied without creating any tension on the paravertebral skin of the lumbar spine

Post Exp: Left Ankle DorsiflexionPost Exp: Right Ankle DorsiflexionPost Exp: pain assessment in the spinous processes of the spine with 1kgPost Exp: pain assessment in the spinous processes of the spine with 2kgPost Exp: pain assessment in the spinous processes of the spine with 3kgPost Exp: pain assessment in the spinous processes of the spine with maximum pressure

Kinesiology tape is applied without creating any tension on the paravertebral skin of the lumbar spine

Post Pla: Left Ankle DorsiflexionPost Pla: Right Ankle DorsiflexionPost Pla: pain assessment in the spinous processes of the spine with 1kgPost Pla: pain assessment in the spinous processes of the spine with 2kgPost Pla: pain assessment in the spinous processes of the spine with 3kgPost Pla: pain assessment in the spinous processes of the spine with maximum pressure

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)

Clínica Dr Francisco Selva

Valencia, 46008, Spain

Location

MeSH Terms

Conditions

Back PainPainLow Back Pain

Condition Hierarchy (Ancestors)

Neurologic 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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD physiotherapy

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 6, 2021

Study Start

March 21, 2022

Primary Completion

September 8, 2022

Study Completion

September 11, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations