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Investigation of the Efficacy of Rocabado Exercises in Individuals With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neck Stabilization Exercise
Neck Stabilization Exercise + Rocabado Exercises
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring chronic neck pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being between the ages of 18-65 Having neck pain for 3 months, Being sedentary Not participating in any physical therapy program in the last 6 months. Exclusion Criteria: Being history of previous spinal surgery or trauma, Beingneurological deficit, vestibular pathology, neurological, cardiopulmonary, musculoskeletal problems affecting physical performance Being any pathology in the shoulder joint, any pathology in the jaw joint, and pregnancy were determined.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control Group

    Intervention group

    Arm Description

    The patients in the control group will be given cervical stabilization exercises consisting of 3 levels and increasing difficulty. The exercises will be taught to the patients level by level by the physiotherapist for 6 weeks. The subjects will perform the exercises for a total of 6 weeks. Before each exercise session, stretching exercises will be performed on the subjects.

    The exercises to be applied to the control group for 6 weeks will be given to the intervention group in the same order and at weekly intervals. Additionally, Robacado exercises (jaw exercises) will be given to the individuals in this group.

    Outcomes

    Primary Outcome Measures

    Pain assessment
    Visual Analog Scale (VAS) will be used for the presence and severity of neck pain in the individuals included in the study. Each participant will be asked about the presence and severity of pain at the beginning and end of the study and recorded. For VAS, individuals are asked to indicate the degree of pain they have on the VAS scale, numbered from 0 to 10 on a straight line, with "0" being no pain and "10" being the most severe pain and recorded.

    Secondary Outcome Measures

    Joint Range of Motion assessment
    Cervical region flexion, extension, right-left rotation and right-left lateral flexion range of motion of individuals will be evaluated with clinical goniometer.
    Proprioception assessment
    The Cervical Joint Position Error Test (CJPET) is used to evaluate cervical region proprioception. CJPET assesses cervical proprioception in four positions (flexion, extension, left rotation, and right rotation). It is based on the principle of finding a point while the eyes are closed. 10 repetitions for each position were done. The first four measurements are trials and the average of the last six measurements gives us the joint position error

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    June 1, 2023
    Sponsor
    Kirsehir Ahi Evran Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05887349
    Brief Title
    Investigation of the Efficacy of Rocabado Exercises in Individuals With Chronic Neck Pain
    Official Title
    Investigation of the Efficacy of Rocabado Exercises in Individuals With Chronic Neck Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kirsehir Ahi Evran Universitesi

    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
    Nerve compression, disc herniation, and fracture-related factors may play a role in the etiology of chronic neck pain, or the pain may not be associated with a specific cause. In the cervical region, muscles, fascia, disc, nerve root and facet joints are the structures that carry pain. Problems related to these structures can also cause pain in the cervical region and shoulder, arm, interscapular region and craniocervical structures. The stomatognathic system is the integrity of the structures that perform the functions of chewing, swallowing and speaking. This system in the head and neck region; It consists of bones, muscles, joints, ligaments, teeth, supporting dental tissues, glands, tongue, mouth and surrounding tissues, and neuromuscular system. The relationship between the stomatognathic and craniocervical systems is demonstrated by the interaction between masticatory and cervical muscles. Wiesinger et al. examined the relationship between spinal pain and temporamandibular joint disorders in a large sample and stated that both conditions may share common risk factors or affect each other. The coexistence of cervical spine and temporomandibular joint pathologies (TMJ) is explained by the neuroanatomical convergence of nociceptive neurons receiving trigeminal and neck sensory inputs. Studies have shown that neck disability may be accompanied by jaw joint disability, masseter myofascial pain, and regional muscle tenderness. Olivio et al. He reported that the treatment of individuals with TMJ pathology should also focus on the neck region, because improvement of one may affect the other. Based on this idea, Calixtre et al. reported that they achieved positive improvements in pain and jaw functions in their study investigating the effects of cervical region mobilization and exercises on individuals with TMJ.
    Detailed Description
    Nerve compression, disc herniation, and fracture-related factors may play a role in the etiology of chronic neck pain, or the pain may not be associated with a specific cause. In the cervical region, muscles, fascia, disc, nerve root and facet joints are the structures that carry pain. Problems related to these structures can also cause pain in the cervical region and shoulder, arm, interscapular region and craniocervical structures. The stomatognathic system is the integrity of the structures that perform the functions of chewing, swallowing and speaking. This system in the head and neck region; It consists of bones, muscles, joints, ligaments, teeth, supporting dental tissues, glands, tongue, mouth and surrounding tissues, and neuromuscular system. The relationship between the stomatognathic and craniocervical systems is demonstrated by the interaction between masticatory and cervical muscles. Wiesinger et al. examined the relationship between spinal pain and temporamandibular joint disorders in a large sample and stated that both conditions may share common risk factors or affect each other. The coexistence of cervical spine and temporomandibular joint pathologies (TMJ) is explained by the neuroanatomical convergence of nociceptive neurons receiving trigeminal and neck sensory inputs. Studies have shown that neck disability may be accompanied by jaw joint disability, masseter myofascial pain, and regional muscle tenderness. Olivio et al. He reported that the treatment of individuals with TMJ pathology should also focus on the neck region, because improvement of one may affect the other. Based on this idea, Calixtre et al. reported that they achieved positive improvements in pain and jaw functions in their study investigating the effects of cervical region mobilization and exercises on individuals with TMJ. In the treatment of chronic neck pain, it has been shown that craniocervical flexion exercise, cervical stabilization and endurance exercises, aerobic exercises, proprioceptive exercises and patient education, especially strengthening exercises for deep and superficial flexor muscles, reduce pain and improve quality of life by increasing muscle strength and functions. In the literature, the number of studies investigating the effectiveness of an exercise program for the jaw joint in individuals with chronic neck pain is quite limited. In this context, our aim is to investigate the effects of Rocabado exercises, one of the jaw joint exercises, on pain, pain threshold/tolerance, range of motion, proprioception, disability, quality of life, muscle strength, muscle endurance, sleep quality and posture 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
    Neck Pain
    Keywords
    chronic neck pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trials
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    The patients in the control group will be given cervical stabilization exercises consisting of 3 levels and increasing difficulty. The exercises will be taught to the patients level by level by the physiotherapist for 6 weeks. The subjects will perform the exercises for a total of 6 weeks. Before each exercise session, stretching exercises will be performed on the subjects.
    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    The exercises to be applied to the control group for 6 weeks will be given to the intervention group in the same order and at weekly intervals. Additionally, Robacado exercises (jaw exercises) will be given to the individuals in this group.
    Intervention Type
    Other
    Intervention Name(s)
    Neck Stabilization Exercise
    Intervention Description
    1. Control Group exercise program (Cervical Stabilization exercises group) The patients in the control group will be given cervical stabilization exercises consisting of 3 levels and increasing difficulty. The exercises will be taught to the patients level by level by the physiotherapist for 6 weeks. The subjects will perform the exercises for a total of 6 weeks. Before each exercise session, stretching exercises will be performed on the subjects.
    Intervention Type
    Other
    Intervention Name(s)
    Neck Stabilization Exercise + Rocabado Exercises
    Intervention Description
    2. Intervention group exercise program (the group to which Robacado exercises will be added in addition to cervical stabilization exercises) The exercises to be applied to the control group for 6 weeks will be given to the intervention group in the same order and at weekly intervals. In addition, individuals in this group will be given Robacado exercises. Robacado exercises: Resting position for the tongue: The tip of the tongue is placed on the upper palate, just behind the front teeth (resting position for the tongue). When the body is in an upright position, scapular retraction and depression movements are performed without disturbing the position of the cervical region. When the body is in an upright position, at C2-C7 levels, hands are clamped on the neck and cranio-cervical flexion is studied.
    Primary Outcome Measure Information:
    Title
    Pain assessment
    Description
    Visual Analog Scale (VAS) will be used for the presence and severity of neck pain in the individuals included in the study. Each participant will be asked about the presence and severity of pain at the beginning and end of the study and recorded. For VAS, individuals are asked to indicate the degree of pain they have on the VAS scale, numbered from 0 to 10 on a straight line, with "0" being no pain and "10" being the most severe pain and recorded.
    Time Frame
    6 week
    Secondary Outcome Measure Information:
    Title
    Joint Range of Motion assessment
    Description
    Cervical region flexion, extension, right-left rotation and right-left lateral flexion range of motion of individuals will be evaluated with clinical goniometer.
    Time Frame
    6 week
    Title
    Proprioception assessment
    Description
    The Cervical Joint Position Error Test (CJPET) is used to evaluate cervical region proprioception. CJPET assesses cervical proprioception in four positions (flexion, extension, left rotation, and right rotation). It is based on the principle of finding a point while the eyes are closed. 10 repetitions for each position were done. The first four measurements are trials and the average of the last six measurements gives us the joint position error
    Time Frame
    6 week

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being between the ages of 18-65 Having neck pain for 3 months, Being sedentary Not participating in any physical therapy program in the last 6 months. Exclusion Criteria: Being history of previous spinal surgery or trauma, Beingneurological deficit, vestibular pathology, neurological, cardiopulmonary, musculoskeletal problems affecting physical performance Being any pathology in the shoulder joint, any pathology in the jaw joint, and pregnancy were determined.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mehmet CANLI
    Phone
    05415501346
    Email
    canlimehmet600@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Investigation of the Efficacy of Rocabado Exercises in Individuals With Chronic Neck Pain

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