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Graston Technique and Classical Massage for Chronic Neck Pain of Children

Primary Purpose

Neck, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Graston technique
Classical Massage
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck focused on measuring graston, massage, children, musculoskeletal

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The children who have a chronic neck pain diagnosed by physician.
  • The children who have minimum 10 degree limitation in at least one of neck movements.
  • The children who have pain in neck region higher than 3 from Wong Baker pain scale.
  • The children who state that they have neck pain for at least 3 months

Exclusion Criteria:

  • The children who have other pain related to neurological or other orthopedic problem apart from neck region.
  • The children who have any chronic disease requiring use of medicine like Hypertension and Diabetes Mellitus.
  • The children who have open wound in neck region which may affect the interventions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Graston technique group

    Classical massage group

    Arm Description

    For Graston practice, instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at.

    The trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes.

    Outcomes

    Primary Outcome Measures

    Level of Pain measured by Wong-Baker Faces Pain Rating Scale
    The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". The child will be asked to determine their level of pain according to this scale before and after the intervention.

    Secondary Outcome Measures

    Pain Threshold measured by Pressure Algometry
    Pressure algometry will be used to measure threshold. The pressure on the painful region is recorded in number (P).
    Range of motions of neck joint measured by universal goniometer
    Universal goniometer will be used for neck joint. Flexion, extension, lateral flexion and rotations will be recorded in degrees.
    Satisfaction level from the application measured by VAS
    The child will be asked to specify his/her satisfaction from the manual therapy (graston or classical massage) after the practice. The Visual Analogue Scale will be used to show the level. Zero will ne no any satisfaction and Ten will be too much satisfaction. The line starting from zere to ten cm will be given to child and asked to sign how much he/she is satisfied from the intervention.

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    March 25, 2021
    Sponsor
    Eastern Mediterranean University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04817384
    Brief Title
    Graston Technique and Classical Massage for Chronic Neck Pain of Children
    Official Title
    Comparison of Immediate Effects of Graston Technique and Classical Massage in Primary School Children With Chronic Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    August 1, 2021 (Anticipated)
    Study Completion Date
    September 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eastern Mediterranean University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In reviews about manual therapy in children, mild, low-speed spinal mobilizations are emphasized as a safe treatment technique in infants, children and adolescents and have been used in clinics for years. Practices such as manipulation and manual therapy should adjust the force and speed used by the specialist practitioner in accordance with the age and developmental level of the child. Studies have emphasized that massage is an effective method in the treatment of chronic pain for children and adolescents. Significantly low pain and positive mood have been reported by children after these manual therapy sessions. Accordingly, the aim of the planned study is to compare the effects of graston technique and classical massage in children with chronic neck pain.
    Detailed Description
    Although there are new physiotherapy interventions for musculoskeletal pain, it is seen that studies about manual techniques are limited in childhood. Graston technique includes a small metallic instrument known as "strigil" and used for therapeutic purposes in ancient Greece and Rome. Another source is based on the traditional Chinese treatment known as "gua sha". Those who found the Graston technique are Dr. Konin, Dr. Greenstein, and Dr. Schrader. The basis of the Graston technique used today was inspired by James Cyriax. When the effects of the Graston technique are investigated, they aim to reduce pain, evaluate and increase soft tissue mobility, and improve range of motion and function. This technique is applied using specially designed curved stainless steel tools. These devices create micro trauma to restore normal elasticity and function in soft tissue. The different structures of the instruments allow to modify the degree of treatment. Small size instruments can be used on smaller anatomical structures and mild symptoms. Larger sized instruments are suitable for large treatment areas and severe conditions. Instruments are applied to the soft tissue at 30-60 degree angles with multi-directional stroking movements. The application time is applied for a maximum of 30 to 60 seconds per tissue site. In addition, whether the problem is acute or chronic is the most important factor that determines the duration of treatment. Total treatment time with instruments is generally minimum 8 minutes. It is applied with a maximum of 20 minutes. In reviews about manual therapy in children, mild, low-speed spinal mobilizations are emphasized as a safe treatment technique in infants, children and adolescents and have been used in clinics for years. Practices such as manipulation and manual therapy should adjust the force and speed used by the specialist practitioner in accordance with the age and developmental level of the child. Studies have emphasized that massage is an effective method in the treatment of chronic pain for children and adolescents. Significantly low pain and positive mood have been reported by children after these manual therapy sessions. Accordingly, the aim of the planned study is to compare the effects of graston technique and classical massage in children with chronic neck pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck, Pain
    Keywords
    graston, massage, children, musculoskeletal

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Graston technique group
    Arm Type
    Experimental
    Arm Description
    For Graston practice, instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at.
    Arm Title
    Classical massage group
    Arm Type
    Experimental
    Arm Description
    The trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    Graston technique
    Intervention Description
    For Graston practice, children will be asked to sit with a support forward. Vaseline will be used as an intermediate during the application. Instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. Larger instruments will be used for larger areas and smaller for smaller regions and fibrocytic areas. The frequency of the plastering and friction movements will be applied in 60 repetitions per minute. While the graston technique is applied to individuals; Superficial muscles in the entire dorsal region will be included in the treatment. These muscles, respectively, the levator scapula, trapezius, and erroctor spina muscles were selected. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at.
    Intervention Type
    Other
    Intervention Name(s)
    Classical Massage
    Intervention Description
    In the neck massage application, the patient should be prepared, and the clothes in the upper back and neck area should be removed. The position of the patient will be in a sitting position with a pillow in front of him. The trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes.
    Primary Outcome Measure Information:
    Title
    Level of Pain measured by Wong-Baker Faces Pain Rating Scale
    Description
    The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". The child will be asked to determine their level of pain according to this scale before and after the intervention.
    Time Frame
    change from baseline to immediately after the intervention
    Secondary Outcome Measure Information:
    Title
    Pain Threshold measured by Pressure Algometry
    Description
    Pressure algometry will be used to measure threshold. The pressure on the painful region is recorded in number (P).
    Time Frame
    change from baseline to immediately after the intervention
    Title
    Range of motions of neck joint measured by universal goniometer
    Description
    Universal goniometer will be used for neck joint. Flexion, extension, lateral flexion and rotations will be recorded in degrees.
    Time Frame
    change from baseline to immediately after the intervention
    Title
    Satisfaction level from the application measured by VAS
    Description
    The child will be asked to specify his/her satisfaction from the manual therapy (graston or classical massage) after the practice. The Visual Analogue Scale will be used to show the level. Zero will ne no any satisfaction and Ten will be too much satisfaction. The line starting from zere to ten cm will be given to child and asked to sign how much he/she is satisfied from the intervention.
    Time Frame
    immediately after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The children who have a chronic neck pain diagnosed by physician. The children who have minimum 10 degree limitation in at least one of neck movements. The children who have pain in neck region higher than 3 from Wong Baker pain scale. The children who state that they have neck pain for at least 3 months Exclusion Criteria: The children who have other pain related to neurological or other orthopedic problem apart from neck region. The children who have any chronic disease requiring use of medicine like Hypertension and Diabetes Mellitus. The children who have open wound in neck region which may affect the interventions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ZEHRA G TOPCU
    Phone
    +903926303067
    Ext
    2496
    Email
    zehra.guchan@emu.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esra Mıhçıoğlu
    Phone
    +903926303067

    12. IPD Sharing Statement

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