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Effects of Magnetic Tape Over Hip Flexion in Patients With Low Back Pain.

Primary Purpose

Low Back Pain

Status
Withdrawn
Phase
Not Applicable
Locations
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 hip flexion, magnetic tape, Kinovea program, range of motion, pain

Eligibility Criteria

16 Years - 65 Years (Child, 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Placebo Comparator

    Arm Label

    No Intervention:hip flexion

    Experimental: hip flexion

    Placebo Comparator: hip flexion

    Arm Description

    hip flexion pre measurement with extension knee will be performed

    hip flexion post experimental application measurement with Magnetic tape Application with extension knee will be performed

    hip flexion post placebo application measurement with kinesiology tape Application with extension knee will be performed

    Outcomes

    Primary Outcome Measures

    Hip flexion
    Maximum degrees of hip flexion measured with the Kinovea® program. Validated Video Program

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2021
    Last Updated
    July 18, 2022
    Sponsor
    Francisco Selva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04878874
    Brief Title
    Effects of Magnetic Tape Over Hip Flexion in Patients With Low Back Pain.
    Official Title
    Effects of Magnetic Tape Over Hip Flexion in Patients With Low Back Pain.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Logistics and infrastructure problems
    Study Start Date
    June 22, 2021 (Anticipated)
    Primary Completion Date
    June 22, 2021 (Anticipated)
    Study Completion Date
    June 22, 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 hip flexion is measured with the KInovea program. 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 "Consolidated Standards of Reporting Trials" (CONSORT) 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 Passive joint flexion of both hips is assessed by placing the patient in a supine position. The video camera is located paralelar to the hip to make recordings and measurements. The tapes will be placed on the paravertebral skin from L1 to L5 without creating tension. Subsequently, both hips are assessed again, performing hip flexion 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
    hip flexion, magnetic tape, Kinovea program, range of motion, 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:hip flexion
    Arm Type
    No Intervention
    Arm Description
    hip flexion pre measurement with extension knee will be performed
    Arm Title
    Experimental: hip flexion
    Arm Type
    Experimental
    Arm Description
    hip flexion post experimental application measurement with Magnetic tape Application with extension knee will be performed
    Arm Title
    Placebo Comparator: hip flexion
    Arm Type
    Placebo Comparator
    Arm Description
    hip flexion post placebo application measurement with kinesiology tape Application with extension knee 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
    Hip flexion
    Description
    Maximum degrees of hip flexion measured with the Kinovea® program. Validated Video Program
    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
    16 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Magnetic Tape Over Hip Flexion in Patients With Low Back Pain.

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