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Dry Needling With And Without Kinesio Taping® in The Non-Specific Chronic Low Back Pain

Primary Purpose

Non-Spesific Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry needling
Sponsored by
Kars State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Spesific Chronic Low Back Pain focused on measuring Dry needling, Kinesiotape, Low-back pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • having no abnormal results in routine blood tests
  • having no known acute or chronic inflammatory disease
  • an education level required for understanding the applied treatment, interventions

Exclusion Criteria:

  • malignancies
  • active infection
  • history of common inflammatory rheumatic disease
  • trauma in spinal area, skin lesion, presence of infection or open wounds
  • radiculopathy
  • peripheral circulation disorder
  • use of warfarin due to coagulopathy
  • arthropathy
  • congenital or acquired spinal pathology
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    DN plus KT group

    DN group

    Arm Description

    DN plus KT therapy is going to be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy is going to be applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles. Kinesio Taping Application: Tapes is going to be left on the patient's body for 5 days.

    DN will be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy was applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles.

    Outcomes

    Primary Outcome Measures

    Pain pressure threshold
    Amount of pressure (Kg/cm2) applied at the lomber multifidus muscle, quadratus lumborum and gluteus medius muscle myofascial trigger point site that elicit pain for the patient will be reported
    Pain by visual analog scale (VAS)
    Visual analog scale (VAS,0-10) will be used to assess resting, activity and night pain.
    Oswestry disability Index (ODI)
    Changes from the Baseline, ODI is an effective tool to provide information on the extent of backache affecting the patient ability to cope with tasks of everyday life. Ten sections are included in the ODI tool with a total possible score of 5 for each section. The first statement carries a score of 0, and the last has a score of 5.
    Beck Depression Inventory
    This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2019
    Last Updated
    November 18, 2019
    Sponsor
    Kars State Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04170816
    Brief Title
    Dry Needling With And Without Kinesio Taping® in The Non-Specific Chronic Low Back Pain
    Official Title
    Comparing Dry Needling With And Without Kinesio Taping® in The Treatment of Non-Specific Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    March 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kars State Hospital

    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
    We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP).
    Detailed Description
    A total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. Both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in DN therapy. KT application will be performed after every DN session in the study group. Pain will evaluate with visual analog scale, functionality was evaluated with Oswestry Disability Index and the status of depression will be evaluated with Beck Depression Index before the treatment and at the first month.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Spesific Chronic Low Back Pain
    Keywords
    Dry needling, Kinesiotape, Low-back pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DN plus KT group
    Arm Type
    Active Comparator
    Arm Description
    DN plus KT therapy is going to be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy is going to be applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles. Kinesio Taping Application: Tapes is going to be left on the patient's body for 5 days.
    Arm Title
    DN group
    Arm Type
    Active Comparator
    Arm Description
    DN will be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy was applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles.
    Intervention Type
    Device
    Intervention Name(s)
    Dry needling
    Other Intervention Name(s)
    Kinesiotape
    Intervention Description
    DN and KT therapy will be applied 3 sessions in 1-week intervals
    Primary Outcome Measure Information:
    Title
    Pain pressure threshold
    Description
    Amount of pressure (Kg/cm2) applied at the lomber multifidus muscle, quadratus lumborum and gluteus medius muscle myofascial trigger point site that elicit pain for the patient will be reported
    Time Frame
    3 week
    Title
    Pain by visual analog scale (VAS)
    Description
    Visual analog scale (VAS,0-10) will be used to assess resting, activity and night pain.
    Time Frame
    3 week
    Title
    Oswestry disability Index (ODI)
    Description
    Changes from the Baseline, ODI is an effective tool to provide information on the extent of backache affecting the patient ability to cope with tasks of everyday life. Ten sections are included in the ODI tool with a total possible score of 5 for each section. The first statement carries a score of 0, and the last has a score of 5.
    Time Frame
    3 week
    Title
    Beck Depression Inventory
    Description
    This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.
    Time Frame
    3 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: having no abnormal results in routine blood tests having no known acute or chronic inflammatory disease an education level required for understanding the applied treatment, interventions Exclusion Criteria: malignancies active infection history of common inflammatory rheumatic disease trauma in spinal area, skin lesion, presence of infection or open wounds radiculopathy peripheral circulation disorder use of warfarin due to coagulopathy arthropathy congenital or acquired spinal pathology pregnancy

    12. IPD Sharing Statement

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    Dry Needling With And Without Kinesio Taping® in The Non-Specific Chronic Low Back Pain

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