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Short-Term Effects of Dynamic Taping in Patients With Lumbar Disc Herniation

Primary Purpose

Lumbar Disc Herniation, Acute Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic taping technique
Sham taping
Sponsored by
NAİME ULUG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring lumbar disc herniation, dynamic tape, acute pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with diagnose of lumbar disc herniation, self-reported activity pain due to lumbar disc herniation for at least the last 3 months, with pain severity equal to or greater than 3 on a numerical rating scale, patients with no skin irritation, sensitivities or allergies Exclusion Criteria: Patients with spinal pathology, lumbar surgery, motor weakness, urinary or fecal incontinence due to lumbar disc herniation, cauda equina syndrome, pregnancy, neurological or rheumatological condition, dermatitis or pre-existing skin lesion over the taping area, and having dynamic taping allergies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    dynamic tape group

    sham taping group

    Arm Description

    The dynamic tape group

    The sham tape group

    Outcomes

    Primary Outcome Measures

    Pain severity evaluation
    The severity of the pain will be measured with Numerical Rating Scale. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
    Pain threshold measurement
    Pain threshold will be measured Jtech Commander digital algometer

    Secondary Outcome Measures

    The evaluation of lumbar muscle endurance
    Modified Sorenson Test will be used
    The evaluation of balance
    Functional reach test will be used
    Lumbar joint mobility
    Universal goniometer will be used
    Functional movement level
    Timed up and go test will be used

    Full Information

    First Posted
    June 29, 2023
    Last Updated
    July 11, 2023
    Sponsor
    NAİME ULUG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05940519
    Brief Title
    Short-Term Effects of Dynamic Taping in Patients With Lumbar Disc Herniation
    Official Title
    Short-Term Effects of Dynamic Taping on Pain, Pain Threshold, Endurance, Balance, Lumbar Joint Mobility And Functionality in Patients With Lumbar Disc Herniation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 12, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2023 (Anticipated)
    Study Completion Date
    August 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    NAİME ULUG

    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
    Previous evidence has shown that kinesio tape application reduces pain levels and improves disability in patients with chronic low back pain due to lumbar disc herniation. However, it is not known, whether the dynamic taping can decrease back pain, improve endurance of paraspinal muscles, and improve functional capacity in patients with lumbar disk herniation. The aim of the current study is to examine the acute effects of dynamic taping on pain, pain threshold, endurance, balance, lumbar joint mobility and functionality in patients with lumbar disc herniation.
    Detailed Description
    The study will include 34 volunteer adult patients who have been diagnosed with lumbar disc herniation according to the physical examination and magnetic resonance imaging and have referred to the physiotherapy and rehabilitation service by a specialist physician. The patients will be divided into 2 groups as dynamic tape (n=17) and sham tape (n=17). Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups. The outcomes of the study will be analyzed by appropriate statistical methods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation, Acute Pain
    Keywords
    lumbar disc herniation, dynamic tape, acute pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective randomized controlled study
    Masking
    Participant
    Masking Description
    Participant will not informed about the intervention
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dynamic tape group
    Arm Type
    Experimental
    Arm Description
    The dynamic tape group
    Arm Title
    sham taping group
    Arm Type
    Sham Comparator
    Arm Description
    The sham tape group
    Intervention Type
    Other
    Intervention Name(s)
    Dynamic taping technique
    Intervention Description
    The dynamic taping method as specified in the literature will be applied to the right and left lumbar paravertebral muscles in the dynamic taping group. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.
    Intervention Type
    Other
    Intervention Name(s)
    Sham taping
    Intervention Description
    Sham taping will be applied with a surgical patch while the patient is in a comfortable position without any technique or stretching.Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.
    Primary Outcome Measure Information:
    Title
    Pain severity evaluation
    Description
    The severity of the pain will be measured with Numerical Rating Scale. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
    Time Frame
    Up to one month
    Title
    Pain threshold measurement
    Description
    Pain threshold will be measured Jtech Commander digital algometer
    Time Frame
    Up to one month
    Secondary Outcome Measure Information:
    Title
    The evaluation of lumbar muscle endurance
    Description
    Modified Sorenson Test will be used
    Time Frame
    Up to one month
    Title
    The evaluation of balance
    Description
    Functional reach test will be used
    Time Frame
    Up to one month
    Title
    Lumbar joint mobility
    Description
    Universal goniometer will be used
    Time Frame
    Up to one month
    Title
    Functional movement level
    Description
    Timed up and go test will be used
    Time Frame
    Up to one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with diagnose of lumbar disc herniation, self-reported activity pain due to lumbar disc herniation for at least the last 3 months, with pain severity equal to or greater than 3 on a numerical rating scale, patients with no skin irritation, sensitivities or allergies Exclusion Criteria: Patients with spinal pathology, lumbar surgery, motor weakness, urinary or fecal incontinence due to lumbar disc herniation, cauda equina syndrome, pregnancy, neurological or rheumatological condition, dermatitis or pre-existing skin lesion over the taping area, and having dynamic taping allergies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    M.Fatih Adalı, Msc.
    Phone
    +905543298251
    Email
    fzt.fadali@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Short-Term Effects of Dynamic Taping in Patients With Lumbar Disc Herniation

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