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Effectiveness of Mulligan Mobilization Technique And Cervical Stabilization Training in Patients With Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home exercise
Mulligan mobilization
Cervical stabilization
Sponsored by
Serbay SEKEROZ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having neck pain lasting more than 3 months
  • Expressing neck pain at least 3,5/10 points and above on a Visual Analog Scale
  • Being 18-65 years old
  • Agree to participate in the study
  • Having obtained 5/50 points and above in Neck Disability Index

Exclusion Criteria:

  • Having had spinal surgery
  • Other musculoskeletal problems that may affect the cervical region such as impingement, thoracic outlet and scoliosis.
  • Having a diagnosed psychiatric illness
  • Having benefited from physiotherapy and / or another treatment method due to spinal pain problem in the last 1 year.
  • The presence of specific pathological conditions such as malignant condition, fracture, systemic rheumatoid disease.
  • Any health problem that may prevent the application of evaluations and / or treatment other than those mentioned above.
  • Difficulty in communication at a level that prevents the application of evaluations and / or treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Home exercise

    Mulligan mobilization

    Cervical stabilization

    Arm Description

    The exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises.

    Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions. Sixty seconds of rest will be given between sets.

    In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles.

    Outcomes

    Primary Outcome Measures

    Pain Intensity
    Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-10 cm, where 0 is the lowest pain and 10 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in cm.
    Neck Disability
    Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability.
    Cervical Range of Motion
    Cervical Range of Motion will be assessed by Baseline Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.
    Head Posture
    Head posture will be evaluated using the craniovertebral angle. The decrease in the craniovertebral angle indicates an increased anterior head posture.
    Proprioception
    The "joint position sense error test" defined by Revel et al. Will be used to evaluate cervical proprioception.
    Muscle Endurance
    "Cervical Deep Flexor Muscle Endurance Test" will be used.
    Neck Awareness
    The Fremantle Neck Awareness Questionnaire, which consists of few and short questions, does not take time, is easy to access, evaluates neck perception, attention and proprioceptive awareness, will be used. An increase in the score obtained from the questionnaire indicates a decrease in neck awareness.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2020
    Last Updated
    November 22, 2020
    Sponsor
    Serbay SEKEROZ
    Collaborators
    The Scientific and Technological Research Council of Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04643028
    Brief Title
    Effectiveness of Mulligan Mobilization Technique And Cervical Stabilization Training in Patients With Chronic Neck Pain
    Official Title
    Comparison of Effectiveness of Mulligan Mobilization Technique and Cervical Stabilization Training in Patients With Chronic Neck Pain: A Single-Blinded Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    July 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Serbay SEKEROZ
    Collaborators
    The Scientific and Technological Research Council of Turkey

    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
    The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.
    Detailed Description
    The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively. The hypotheses we will test for this purpose; H1. Home exercise program will improve positively after treatment in patients with chronic neck pain compared to before treatment. H2. Mulligan mobilization will improve positively after treatment in patients with chronic neck pain compared to before treatment. H3. Cervical stabilization training will improve positively after treatment in patients with chronic neck pain compared to before treatment. H4. Mulligan mobilization will provide more effective results in patients with chronic neck pain compared to other applications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Neck Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The evaluator who made the outcome measurements will not have any information about the group of participants.
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Home exercise
    Arm Type
    Other
    Arm Description
    The exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises.
    Arm Title
    Mulligan mobilization
    Arm Type
    Other
    Arm Description
    Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions. Sixty seconds of rest will be given between sets.
    Arm Title
    Cervical stabilization
    Arm Type
    Other
    Arm Description
    In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles.
    Intervention Type
    Other
    Intervention Name(s)
    Home exercise
    Intervention Description
    Exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises.
    Intervention Type
    Other
    Intervention Name(s)
    Mulligan mobilization
    Intervention Description
    Mulligan mobilization: Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions.Sixty seconds of rest will be given between sets.
    Intervention Type
    Other
    Intervention Name(s)
    Cervical stabilization
    Intervention Description
    Cervical stabilization group: In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles.
    Primary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-10 cm, where 0 is the lowest pain and 10 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in cm.
    Time Frame
    5 minutes
    Title
    Neck Disability
    Description
    Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability.
    Time Frame
    5 minutes
    Title
    Cervical Range of Motion
    Description
    Cervical Range of Motion will be assessed by Baseline Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.
    Time Frame
    5 minutes
    Title
    Head Posture
    Description
    Head posture will be evaluated using the craniovertebral angle. The decrease in the craniovertebral angle indicates an increased anterior head posture.
    Time Frame
    5 minutes
    Title
    Proprioception
    Description
    The "joint position sense error test" defined by Revel et al. Will be used to evaluate cervical proprioception.
    Time Frame
    5 minutes
    Title
    Muscle Endurance
    Description
    "Cervical Deep Flexor Muscle Endurance Test" will be used.
    Time Frame
    3 minutes
    Title
    Neck Awareness
    Description
    The Fremantle Neck Awareness Questionnaire, which consists of few and short questions, does not take time, is easy to access, evaluates neck perception, attention and proprioceptive awareness, will be used. An increase in the score obtained from the questionnaire indicates a decrease in neck awareness.
    Time Frame
    5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having neck pain lasting more than 3 months Expressing neck pain at least 3,5/10 points and above on a Visual Analog Scale Being 18-65 years old Agree to participate in the study Having obtained 5/50 points and above in Neck Disability Index Exclusion Criteria: Having had spinal surgery Other musculoskeletal problems that may affect the cervical region such as impingement, thoracic outlet and scoliosis. Having a diagnosed psychiatric illness Having benefited from physiotherapy and / or another treatment method due to spinal pain problem in the last 1 year. The presence of specific pathological conditions such as malignant condition, fracture, systemic rheumatoid disease. Any health problem that may prevent the application of evaluations and / or treatment other than those mentioned above. Difficulty in communication at a level that prevents the application of evaluations and / or treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Serbay Şekeröz, MSc
    Phone
    +905453009060
    Email
    serbaysekeroz@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emine Aslan Telci, Professor
    Phone
    +902582964272
    Email
    easlantelci@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emine Aslan Telci, Professor
    Organizational Affiliation
    Professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of Mulligan Mobilization Technique And Cervical Stabilization Training in Patients With Chronic Neck Pain

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