NCT04893967

Brief Summary

The tape will be applied on the lumbar area bilaterally to the spine without creating any tension. The possible variation in the isometric hip strength is measured with the mDurance®, surface electromyography and the Lafayette® dynamometer. 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
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 14, 2022

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

May 10, 2021

Last Update Submit

April 7, 2022

Conditions

Low Back Pain

Keywords

strengthpainlow back paindynamometerabductionsurface electromyogrammagnetic tapekinesiology tapeHip Stability Isometric Test (HipSIT)

Outcome Measures

Primary Outcomes (4)

  • muscle fiber activation

    Maximum isometric strength of hip abduction measured with the mDurance® surface electromyograph.

    Changes for activity (microvolts) first evaluation before placing the tapes and immediately after placing the experimental tape and the placebo tape.

  • Peak force of hip abduction

    Maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.

    Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.

  • Average force of hip abduction

    Mean isometric strength of hip abduction measured with the Lafayette® dynamometer.

    Changes from strength (kilograms) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.

  • Time to reach peak force of hip abduction

    Time to maximum isometric strength of hip abduction measured with the Lafayette® dynamometer.

    Changes from time (seconds) in first assessment before placing the tapes and immediately after placing experimental tape and placebo tape.

Study Arms (18)

No Intervention: RMS mean hip abduction, dynamometer

NO INTERVENTION

Isometric peak force hip abduction pre measurement. No tape.

No Intervention: Average force hip abduction, dynamometer

NO INTERVENTION

Isometric average force hip abduction pre measurement. No tape.

No Intervention: Time to reach peak force hip abduction, dynamometer

NO INTERVENTION

Time to reach peak force hip abduction pre measurement. No tape.

No Intervention: RMS mean hip abduction, surface electromyogram

NO INTERVENTION

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean. No tape.

No Intervention: RMS mean per second hip abduction, surface electromyogram

NO INTERVENTION

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) mean per second. No tape.

No Intervention: Max. contraction test hip abduction, surface electromyogram

NO INTERVENTION

Isometric hip abduction pre measurement assessing the root-mean-square (RMS) Max. contraction test. No tape.

Experimental: peak force hip abduction, dynamometer

EXPERIMENTAL

Isometric peak force hip abduction post experimental application measurement with Magnetic Tape application

Device: Magnetic Tape

Experimental: Average force hip abduction, dynamometer

EXPERIMENTAL

Isometric average force hip abduction post experimental application measurement with Magnetic Tape application

Device: Magnetic Tape

Experimental: time to maximum force hip abduction, dynamometer

EXPERIMENTAL

Time to maximum force hip abduction post experimental application measurement with Magnetic Tape application

Device: Magnetic Tape

Experimental: RMS mean hip abduction, surface electromyogram

EXPERIMENTAL

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) with Magnetic Tape application.

Device: Magnetic Tape

Experimental: RMS mean per second hip abduction, surface electromyogram

EXPERIMENTAL

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) mean per second. With Magnetic Tape application.

Device: Magnetic Tape

Experimental: Max. contraction test hip abduction, surface electromyogram

EXPERIMENTAL

Isometric hip abduction post experimental application measurement assessing the root-mean-square (RMS) max. contraction test. With Magnetic Tape application.

Device: Magnetic Tape

Placebo: peak force hip abduction, dynamometer

PLACEBO COMPARATOR

Isometric peak force hip abduction post placebo measurement with kinesiology tape application

Device: kinesiology tape

Placebo: Average force hip abduction, dynamometer

PLACEBO COMPARATOR

Isometric average force hip abduction post placebo application measurement with kinesiology tape application

Device: kinesiology tape

Placebo: Time to reach peak force hip abduction, dynamometer

PLACEBO COMPARATOR

Time to reach peak force hip abduction post placebo application measurement with kinesiology tape application

Device: kinesiology tape

Placebo: RMS mean hip abduction, surface electromyogram

PLACEBO COMPARATOR

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean. With kinesiology tape application.

Device: kinesiology tape

Placebo: RMS mean per second hip abduction, surface electromyogram

PLACEBO COMPARATOR

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) mean per second. With kinesiology tape application.

Device: kinesiology tape

Placebo: Max. contraction test hip abduction, surface electromyogram

PLACEBO COMPARATOR

Isometric hip abduction post placebo application measurement assessing the root-mean-square (RMS) max. contraction test. With kinesiology tape application.

Device: kinesiology tape

Interventions

Magnetic TapeDEVICE

Magnetic tape® is applied without creating any tension over low back

Experimental: Average force hip abduction, dynamometerExperimental: Max. contraction test hip abduction, surface electromyogramExperimental: RMS mean hip abduction, surface electromyogramExperimental: RMS mean per second hip abduction, surface electromyogramExperimental: peak force hip abduction, dynamometerExperimental: time to maximum force hip abduction, dynamometer
kinesiology tapeDEVICE

Kinesiology Tape is applied without creating any tension over low back

Placebo: Average force hip abduction, dynamometerPlacebo: Max. contraction test hip abduction, surface electromyogramPlacebo: RMS mean hip abduction, surface electromyogramPlacebo: RMS mean per second hip abduction, surface electromyogramPlacebo: Time to reach peak force hip abduction, dynamometerPlacebo: peak force hip abduction, dynamometer

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 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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director PhD

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 20, 2021

Study Start

October 11, 2021

Primary Completion

February 11, 2022

Study Completion

March 1, 2022

Last Updated

April 14, 2022

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)