Effects of Magnetic Tape on Perceived Spine Pain and Over Ankle Dorsiflexion in Patients With Low Back Pain
1 other identifier
interventional
39
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
May 6, 2021
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2022
CompletedSeptember 15, 2022
September 1, 2022
6 months
April 26, 2021
September 13, 2022
Conditions
Keywords
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 INTERVENTIONpress on the spinous processes with the algometer perpendicularly.
Pre: pain assessment in the spinous processes of the spine with 2 kg
NO INTERVENTIONpress on the spinous processes with the algometer perpendicularly.
Pre: pain assessment in the spinous processes of the spine with 3 kg
NO INTERVENTIONpress on the spinous processes with the algometer perpendicularly.
Pre: pain assessment in the spinous processes of the spine with maximum pressure
NO INTERVENTIONpress on the spinous processes with the algometer perpendicularly.
Post Exp: pain assessment in the spinous processes of the spine with 1kg
EXPERIMENTALpress on the spinous processes with the algometer perpendicularly.
Post Exp: pain assessment in the spinous processes of the spine with 2kg
EXPERIMENTALpress on the spinous processes with the algometer perpendicularly.
Post Exp: pain assessment in the spinous processes of the spine with 3kg
EXPERIMENTALpress on the spinous processes with the algometer perpendicularly.
Post Exp: pain assessment in the spinous processes of the spine with maximum pressure
EXPERIMENTALpress on the spinous processes with the algometer perpendicularly.
Post Pla: pain assessment in the spinous processes of the spine with 1kg
PLACEBO COMPARATORpress on the spinous processes with the algometer perpendicularly.
Post Pla: pain assessment in the spinous processes of the spine with 2kg
PLACEBO COMPARATORpress on the spinous processes with the algometer perpendicularly.
Post Pla: pain assessment in the spinous processes of the spine with 3kg
PLACEBO COMPARATORpress on the spinous processes with the algometer perpendicularly.
Post Pla: pain assessment in the spinous processes of the spine with maximum pressure
PLACEBO COMPARATORpress on the spinous processes with the algometer perpendicularly.
Pre: Right Ankle Dorsiflexion
NO INTERVENTIONRange of motion in right ankle dorsiflexion is measured with LegMOtion®
Post Pla: Right Ankle Dorsiflexion
PLACEBO COMPARATORRange of motion in right ankle dorsiflexion is measured with LegMOtion®
Post Exp: Right Ankle Dorsiflexion
EXPERIMENTALRange of motion in right ankle dorsiflexion is measured with LegMOtion®
Pre: Left Ankle Dorsiflexion
NO INTERVENTIONRange of motion in left ankle dorsiflexion is measured with LegMOtion®
Post Pla: Left Ankle Dorsiflexion
PLACEBO COMPARATORRange of motion in left ankle dorsiflexion is measured with LegMOtion®
Post Exp: Left Ankle Dorsiflexion
EXPERIMENTALRange of motion in left ankle dorsiflexion is measured with LegMOtion®
Interventions
Magnetic tape® is applied without creating any tension on the paravertebral skin of the lumbar spine
Kinesiology tape is applied without creating any tension on the paravertebral skin of the lumbar spine
Eligibility Criteria
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
- Francisco Selvalead
Study Sites (1)
Clínica Dr Francisco Selva
Valencia, 46008, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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