search
Back to results

Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Magnetic Tape®
Kinesiology Tape
Sponsored by
Francisco Selva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring ankle dorsiflexion, Magnetic Tape®, LegMOtion®, pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cliniva Dr Francisco Selva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Placebo Comparator

Arm Label

No Intervention: ankle dorsiflexion

Experimental: ankle dorsiflexion

Placebo: ankle dorsiflexion

Arm Description

ankle dorsiflexion pre measurement with bipedestation position, will be performed

ankle dorsiflexion post measurement with bipedestation position, will be performed

ankle dorsiflexion post measurement with bipedestation position, will be performed

Outcomes

Primary Outcome Measures

Range of motion
Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System

Secondary Outcome Measures

Full Information

First Posted
May 6, 2021
Last Updated
July 18, 2022
Sponsor
Francisco Selva
search

1. Study Identification

Unique Protocol Identification Number
NCT04883112
Brief Title
Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain
Official Title
Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Logistics and infrastructure problems
Study Start Date
July 4, 2021 (Anticipated)
Primary Completion Date
July 4, 2021 (Anticipated)
Study Completion Date
July 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Selva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The tape will be applied on the lumbar area bilateralemten to the spine without creating any tension. 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.
Detailed Description
A triple-blind cross-sectional observational study is designed where subjects with low back pain will be selected and blinded to receive the Magnetic Tape® (tape with magnetic effects of less than 2 Gauss) or placebo Tape. Likewise, the evaluator who puts the Magnetic Tape® does not know what material he is using, as it is supplied by another researcher. The patient does not know what tape will be placed on him. The recommendations of the "Reporting of Observational Studies in Epidemiology" (STROBE) will be followed. All participants will receive a participant information sheet and sign informed consent. Patients aged 18 to 65 years with low back pain will be recruited from different private clinics in the city of Valencia, Spain. The hypothesis is that when Magnetic Tape® comes into contact with electromagnetic fields such as those generated by living beings, due to the movement of electrical charges (ions), as defined by Ampere's Law, the domains of the tape are oriented or aligned in parallel with the external magnetic field creating a magnetic flux with a north pole and a south pole. This generated field in turn produces a magnetic induction proportional to the variation of the magnetic flux, as defined by the Faraday Law. This electric potential produces a redistribution of the electric charge (ions) generating a magnetic field due to the orientation of the tape domains, then exerting a force on the moving charges within the electrolyte. Physiological, Lorentz's Law, regulating Magnetic Tape® aberrant electromagnetic fields. The protocol for data collection will be as follows: After signing the informed consent and data protection, the groups with low back pain will be formed that will receive the application of both Magnetic Tape® and the intervention of a placebo tape. To avoid that the order of the intervention influences the results of the study, the subjects will be randomized into two different groups, Group A and Group B. Group A will receive Magnetic tape® and Group B will do the opposite. The next day the other tape will be applied. active joint ROM of both ankles is assessed by placing the patient in bipedestation. LegMOtion® will be used for to make measurements. The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension. Subsequently, both ankles are assessed again, performing active ankle dorsiflexion again and recording the degrees of range of motion. Each subject will be your control since one day a tape will be placed and the next day the other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
ankle dorsiflexion, Magnetic Tape®, LegMOtion®, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: ankle dorsiflexion
Arm Type
No Intervention
Arm Description
ankle dorsiflexion pre measurement with bipedestation position, will be performed
Arm Title
Experimental: ankle dorsiflexion
Arm Type
Experimental
Arm Description
ankle dorsiflexion post measurement with bipedestation position, will be performed
Arm Title
Placebo: ankle dorsiflexion
Arm Type
Placebo Comparator
Arm Description
ankle dorsiflexion post measurement with bipedestation position, will be performed
Intervention Type
Device
Intervention Name(s)
Magnetic Tape®
Intervention Description
Magnetic tape® is applied without creating any tension over low back
Intervention Type
Device
Intervention Name(s)
Kinesiology Tape
Intervention Description
Kinesiology tape is applied without creating any tension over low back
Primary Outcome Measure Information:
Title
Range of motion
Description
Maximum centimeters of ankle dorsiflexion measured with LegMOtion® Therapeutic and Corrective Exercise Assessment System
Time Frame
Changes from Range of motion first assessment before placing the tapes and inmediatly after placing experimental tape and placebo tape.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with low back pain. Subjects aged 18-65 years. Exclusion Criteria: 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.
Facility Information:
Facility Name
Cliniva Dr Francisco Selva
City
Valencia
ZIP/Postal Code
46008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Magnetic Tape Over Ankle Dorsiflexion in Patients With Low Back Pain

We'll reach out to this number within 24 hrs