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Withdrawn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Withdrawn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