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
CRIS Registration Number |
KCT0003358 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Daejeon University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Daejeon University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M43.62)Torticollis, cervical region |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Pain level (Numeric pain rating scale) |
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Timepoint | intervention pre, post, follow up (2 month) - 3 session |
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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 ) |
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Timepoint | intervention pre, post, follow up (2 month) - 3 session |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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