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The Effect Of Kinesio Tape In Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Kinesio tape procedure
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Neck Pain, Kinesio tape, Pain, Quality of Life

Eligibility Criteria

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

Inclusion Criteria:

  • Being between the ages of 30-55,
  • Having been suffering from neck pain for at least three months,
  • Getting at least 5 points from the Neck Disability Index,
  • Having pain between the superior nuchal line and spina scapula,
  • Neck Pain Task Force, which consists of four levels to be at the first and second level.

Exclusion Criteria:

  • Presence of conditions that will prevent evaluation or communication (such as cognitive problems),
  • Being illiterate,
  • Having had physiotherapy from the neck, back or waist region in the last six months,
  • Having had cervical region and spine surgery,
  • Presence of impingement or thoracic outlet syndrome, malignancy, fractured, systemic autoimmune diseases, neurological problems and diagnosed psychiatric diseases that will prevent evaluation and treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Conventional rehabilitation treatment

    Kinesio tape procedure

    Arm Description

    Conventional physiotherapy program, consisting of standardised active (exercise) and passive (hotpack, ultrasound, conventional TENS) physical therapy methods, was applied by the same physiotherapist.

    In addition to the conventional physiotherapy program Kinesio tape was performed every day of conventional treatment immediately after the session ended by the same physiotherapist.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale
    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Visual Analogue Scale was used to evaluate pain intensity. The highest score is 10, the lowest is 0. High scores indicate that pain intensity is high.
    Pressure pain threshold
    Pressure pain threshold was evaluated with an objective method, digital algometer. The results are recorded in Newton / cm2.
    Cervical range of motion
    Cervical range of motion was evaluated with the Cervical Range of Motion device.All movements were actively carried out, and measurement results were recorded in degrees.
    Isometric muscle strengths
    Isometric muscle strengths of the cervical region were evaluated by Hand-Held Dynamometer. The result measurements were recorded in Newton.
    The pectoralis minor muscle shortness
    The pectoralis minor muscle shortness of the participants was evaluated with a standard bilateral ruler.Muscle shortness was recorded in centimetres.
    The endurance of the deep neck flexor muscles
    The endurance of the deep neck flexor muscles with a chronometer, muscle endurance was recorded in seconds.

    Secondary Outcome Measures

    Neck Disability Index
    Disability levels of the participants were assessed with the Neck Disability Index.The highest score is 50, the lowest is 0. High scores indicate that disability level is high.
    Nottingham Health Profile
    Quality of life were assessed with Nottingham Health Profile.The highest score is 600, the lowest is 0. The increase in score indicates worse quality of life.
    Beck Depression Inventory
    The emotional status were assessed with Beck Depression Inventory. The highest score that can be obtained is 63, the lowest is 0. It has been reported that individuals scoring 17 points or more have severe depressive symptoms that require treatment.
    Treatment satisfaction
    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Treatment satisfaction were assessed with the Visual Analogue Scale. The highest score is 10, the lowest is 0. High scores indicate that treatment satisfaction is high.

    Full Information

    First Posted
    February 10, 2020
    Last Updated
    March 9, 2021
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04279015
    Brief Title
    The Effect Of Kinesio Tape In Chronic Neck Pain
    Official Title
    The Effect Of Kinesio Tape In Chronic Neck Pain: Randomise Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    December 31, 2015 (Actual)
    Study Completion Date
    September 18, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pamukkale University

    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
    This study was planned to investigate the efficacy of treatment for Kinesio tape application in chronic neck pain individuals. A total of 44 individuals were randomly divided into two groups (study group: 22, control group: 22). Conventional physiotherapy methods including active (exercise) and passive (hotpack, ultrasound and conventional transcutaneous electrical nerve stimulation (TENS)) treatment were applied to all subjects for 15 sessions (5 days a week). In addition to the individuals in the study group, Kinesio tape application was performed at the end of each session. Pain (Visual Analogue Scale), pressure pain threshold (digital algometer), range of motion (CROM device), muscle strength (Hand-Held Dynamometer), muscle endurance, pectoralis minor muscle length, quality of life (Nottingham Health Profile) and depressive symptoms (Beck Depression Scale) assessments were performed before treatment, on the second day of treatment and after treatment (after three weeks). Treatment satisfaction with individuals (Visual Analogue Scale) was assessed on the 2nd day of treatment and post-treatment (after three weeks).
    Detailed Description
    In the literature, it is seen that Kinesio tape is used in problems such as knee pain, chronic low back pain, neck pain, shoulder pain and common musculoskeletal pain. Some studies with individuals with low back and neck pain show positive effects of Kinesio tape on pain reduction and recovery in disability. However, studies are reporting the opposite of these results. The number of studies in the literature is insufficient to create clinical evidence regarding the use of Kinesio tape in patients with neck pain. By considering this deficiency, the purpose of our study was to investigate the effect of Kinesio tape applied together with conventional physiotherapy methods in individuals with chronic neck pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Neck Pain
    Keywords
    Neck Pain, Kinesio tape, Pain, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    pretest-posttest control groups in randomized parallel groups
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional rehabilitation treatment
    Arm Type
    Active Comparator
    Arm Description
    Conventional physiotherapy program, consisting of standardised active (exercise) and passive (hotpack, ultrasound, conventional TENS) physical therapy methods, was applied by the same physiotherapist.
    Arm Title
    Kinesio tape procedure
    Arm Type
    Active Comparator
    Arm Description
    In addition to the conventional physiotherapy program Kinesio tape was performed every day of conventional treatment immediately after the session ended by the same physiotherapist.
    Intervention Type
    Procedure
    Intervention Name(s)
    Kinesio tape procedure
    Other Intervention Name(s)
    Conventional rehabilitation treatment
    Intervention Description
    Conventional rehabilitation treatment: Hotpack, ultrasound, conventional TENS and exercise for neck pain. Kinesio taping procedure: Inhibition technique with 15-25% tension to the upper trapezius muscle with I tape to reduce pain and muscle spasm, to support the weak muscles, Facilitation technique with Y-band with 15-35% tension to the cervical paravertebral muscles, and X-band with 15-35% tension to the rhomboideus major muscle technique and the correction technique was applied to the region where the individual defined the most pain and tenderness in palpation by using the "star application".
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Visual Analogue Scale was used to evaluate pain intensity. The highest score is 10, the lowest is 0. High scores indicate that pain intensity is high.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    Pressure pain threshold
    Description
    Pressure pain threshold was evaluated with an objective method, digital algometer. The results are recorded in Newton / cm2.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    Cervical range of motion
    Description
    Cervical range of motion was evaluated with the Cervical Range of Motion device.All movements were actively carried out, and measurement results were recorded in degrees.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    Isometric muscle strengths
    Description
    Isometric muscle strengths of the cervical region were evaluated by Hand-Held Dynamometer. The result measurements were recorded in Newton.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    The pectoralis minor muscle shortness
    Description
    The pectoralis minor muscle shortness of the participants was evaluated with a standard bilateral ruler.Muscle shortness was recorded in centimetres.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    The endurance of the deep neck flexor muscles
    Description
    The endurance of the deep neck flexor muscles with a chronometer, muscle endurance was recorded in seconds.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Secondary Outcome Measure Information:
    Title
    Neck Disability Index
    Description
    Disability levels of the participants were assessed with the Neck Disability Index.The highest score is 50, the lowest is 0. High scores indicate that disability level is high.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    Nottingham Health Profile
    Description
    Quality of life were assessed with Nottingham Health Profile.The highest score is 600, the lowest is 0. The increase in score indicates worse quality of life.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    Beck Depression Inventory
    Description
    The emotional status were assessed with Beck Depression Inventory. The highest score that can be obtained is 63, the lowest is 0. It has been reported that individuals scoring 17 points or more have severe depressive symptoms that require treatment.
    Time Frame
    Evaluations were made before treatment, on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.
    Title
    Treatment satisfaction
    Description
    A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.Treatment satisfaction were assessed with the Visual Analogue Scale. The highest score is 10, the lowest is 0. High scores indicate that treatment satisfaction is high.
    Time Frame
    Evaluations were made on the 2nd day of treatment and after 3 weeks (1 day after completion of treatment) by the same physiotherapist.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being between the ages of 30-55, Having been suffering from neck pain for at least three months, Getting at least 5 points from the Neck Disability Index, Having pain between the superior nuchal line and spina scapula, Neck Pain Task Force, which consists of four levels to be at the first and second level. Exclusion Criteria: Presence of conditions that will prevent evaluation or communication (such as cognitive problems), Being illiterate, Having had physiotherapy from the neck, back or waist region in the last six months, Having had cervical region and spine surgery, Presence of impingement or thoracic outlet syndrome, malignancy, fractured, systemic autoimmune diseases, neurological problems and diagnosed psychiatric diseases that will prevent evaluation and treatment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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