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The effects of sling based manual therapy on patients with chronic mechanical neck pain

Status Approved

  • First Submitted Date

    2018/09/18

  • Registered Date

    2018/11/16

  • Last Updated Date

    2018/11/07

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003358
    Unique Protocol ID 1040647-201706-HR-013-03
    Public/Brief Title The effects of sling equipment based manual therapy on patients with chronic mechanical neck pain
    Scientific Title The effects of sling based manual therapy on patients with chronic mechanical neck pain
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1040647-201706-HR-013-03
    Approval Date 2018-09-05
    Institutional Review Board Name Daejeon University Institutional Review Board
    Institutional Review Board Address 62, Daehak-ro, Dong-gu, Daejeon
    Institutional Review Board Telephone 042-280-2786
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kim Dae Hyun
    Title physical therapist
    Telephone +82-63-250-1720
    Affiliation Jeonbuk National University Hospital
    Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do, Republic of Korea
    Contact Person for Public Queries
    Name Kim Dae Hyun
    Title physical therapist
    Telephone +82-63-250-1720
    Affiliation Jeonbuk National University Hospital
    Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do, Republic of Korea
    Contact Person for Updating Information
    Name Kim Dae Hyun
    Title physical therapist
    Telephone +82-63-250-1720
    Affiliation Jeonbuk National University Hospital
    Address 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2018-11-19 Anticipated
    Target Number of Participant 22
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Jeonbuk National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-11-19 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Daejeon University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daejeon University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Forward head posture is a typical neck disorder in modern society, mainly in office workers and students.Forward head posture (FHP) is identified as the flexion of the lower cervical spine (C4-7) along with the extension of the upper cervical spine (C1-3), Several articles have reported that maintaining this posture causes an abnormal cervical movement pattern and is an important cause of mechanical neck pain. also, It has been reported that the more forward the head is, the greater the tension in the muscles responsible for stabilizing the neck, as well as the compressive force in the cervical joint.
     In previous studies, the angle of the craniovertebral angle decreased as the anterior head posture increased, This posture has been reported to reduce the flexion mobility of the craniocervical region and the activity of the deep cervical flexor muscles. The decreased muscle activity of the deep cervical flexor muscles during flexion of the craniofacial region is related to the increased activity of the superficial muscles such as SCM and anterior scalene. Therefore, most of the interventions related to the anterior head posture in the current clinical practice focus on the upper cervical vertebrae, as well as the cervical and thoracic stretching exercises and the upper extremity and scapular muscle strengthening exercises. There is a lack of research related to the frequency of treatment cervicothoracic junctions. 
     In this study, we compared the results of general intervention (upper cervical manual therapy) for nonspecific neck pain patients with forward head posture and the addition of general intervention and manual therapy of the cervicothoracic joint to compare the effect of pain level, dysfunction, and angle of forward head posture and muscle activity on effectiveness.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase0
    Intervention Model Factorial  
    Blinding/Masking Single
    Blinded Subject Subject, Outcome Accessor
    Allocation RCT
    Intervention Type Others (manual therapy)
    Intervention Description
    control group : manual therapy of upper cervical area
     experimental group : manual therapy of upper cervical area + cervicothoracic junction 
     The difference between the interventions is the difference in segmental level of the vertebrae applying manual therapy.
    Number of Arms 2
    Arm 1

    Arm Label

    manual therapy of upper cervical area

    Target Number of Participant

    11

    Arm Type

    Active comparator

    Arm Description

    Patients were positioned in supine crook lying position with the cervical spine in a neutral position on the sling device (non-elastic cord, cervical strap). One hand of the therapist contacts and fixes the transverse process of C1 (both), while the other hand grabs the occiput and applies mobilization in the dorsal direction (Fig. 2). Subjects in this group applied passive mobilization for only 3 min to the segment (occiput–C1). Segmental motor control training is also performed in the same segment, guiding the range and speed of movement of the subject through the therapist’s hand. This intervention is also performed 3 times for 1 min, with an interval of 1 min.
    Arm 2

    Arm Label

    manual therapy of upper cervical area and cervicothoracic junction

    Target Number of Participant

    11

    Arm Type

    Experimental

    Arm Description

    manual therapy of the upper cervical area is the same as that of the control group.
    Subjects were positioned in the same starting position and had identical intervention time as the uppercervical group. A sling device (elastic cord [red], chest strap) was used in the group to facilitate segmental movement of the cervicothoracic junction (C7–T3). A chest strap was applied to allow contact from the T4 level or less (T5), and the elastic length of the elastic cord was unified to the length of the chest (dorsal part) of each subject not reaching the bed. In order to exclude the effect of arm position on the mediation process, a sling device was additionally applied to maintain the natural position next to the chest (non-elastic cord, elbow/hand strap). One hand of the therapist contacts and fixes the occiput of the subject, and the other hand holds both articular pillars of the vertebrae of the segment (Fig. 2). Passive mobilization was applied to the C7–T1, T1–T2, and T2–T3 levels at 1-min intervals. Segmental motor control training was also performed in the same posture. The subjects were instructed to perform an extension motion at each segment (C7–T1, T1–T2, and T2–T3 levels) while holding a cervical strap supporting the occiput plane. The therapist guided the optimal segmental movement through the hand. This intervention was also applied to each of the three segments at 1-min intervals.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M43.62)Torticollis, cervical region 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~65Year

    Description

    1. non-specific neck pain (Numertic pain rate scale >3)
    2. craniovertebral angle < 52
    Exclusion Criteria
    1. Dizziness 2. CNS lesion, vestibular lesion  3. Neck radicular pain  
    4.A person who has undergone surgery for an orthopedic injury or disease in the spine or upper extremity within the last 6 months.
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Pain level (Numeric pain rating scale)
    Timepoint
    intervention pre, post, follow up (2 month)  - 3 session
    Primary Outcome(s) 2
    Outcome
    dysfunction level (Neck disability index)
    Timepoint
    intervention pre, post, follow up (2 month)  - 3 session
    Primary Outcome(s) 3
    Outcome
    forward head posture angle (Craniovertebral angle)
    Timepoint
    intervention pre, post, follow up (2 month)  - 3 session
    Secondary Outcome(s) 1
    Outcome
    Muscle activity (Electromyography )
    Timepoint
    intervention pre, post, follow up (2 month)  - 3 session
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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