Status Approved
First Submitted Date
2019/08/21
Registered Date
2019/08/23
Last Updated Date
2019/08/22
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004235 |
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Unique Protocol ID | 1040647-201904-HR-001-03 |
Public/Brief Title | Effect of lower trapezius strengthening exercise on neck pain patients |
Scientific Title | Effects of Lower trapezius strengthening exercises on pain, dysfunction, posture alignment, muscle thickness and shrinkage in patients with 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 | 1040647-201904-HR-001-03 |
Approval Date | 2019-08-19 |
Institutional Review Board Name | daejeon-University, Institutional Bioethics Committee |
Institutional Review Board Address | 62, Daehak-ro, Dong-gu, Daejeon |
Institutional Review Board Telephone | 042-280-2786 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | SAMHO PARK |
Title | postgraduate student |
Telephone | +82-42-336-1000 |
Affiliation | Daejeon University |
Address | 62, Daehak-ro, Dong-gu, Daejeon |
Contact Person for Public Queries | |
Name | SAMHO PARK |
Title | postgraduate student |
Telephone | +82-42-336-1000 |
Affiliation | Daejeon University |
Address | 62, Daehak-ro, Dong-gu, Daejeon |
Contact Person for Updating Information | |
Name | SAMHO PARK |
Title | postgraduate student |
Telephone | +82-42-336-1000 |
Affiliation | Daejeon University |
Address | 62, Daehak-ro, Dong-gu, Daejeon |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-08-20 Actual | |
Target Number of Participant | 40 | |
Primary Completion Date | 2019-08-21 , Actual | |
Study Completion Date | 2019-08-21 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Phil Korea Medicine Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-08-20 , |
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 | * Purpose of Research The purpose of this study was to evaluate the effects of lower trapezius strengthening exercise and scapular and thoracic stabilization programs on pain and dysfunction, posture alignment, muscle thickness and shrinkage in neck pain patients. *background -forward head dysfunction consists of a combination of lower cervical flexion and upper cervical extension and the round shoulder posture (RSP) is a combination of abduction and elevation of the scaoular. The two postures combine to form a forward headed rounded shoulder posture (FHRSP). -This posture is one of the general postural modifications seen in patients with neck and shoulder diseases, which may be referred to as a cause of chronic pain due to increased muscle fatigue. -Cervical pain patients are exposed to the risk of experiencing muscle-skeletal disease due to postural muscle rigidity and hypokinetics. -Lower trapezius plays an essential role in stabilizing the scapula in the scapula. The hyperactivity and shortening of the upper trapezius in the long term leads to the weakening of the trapezius, resulting in imbalance of the muscles. Many studies have suggested that a therapeutic approach is needed to strengthen weakened muscles for ideal posture alignment and to apply the kidney motion to shortened muscles. →The purpose of this study was to investigate the effect of lower trapezius strengthening exercise on pain, motor function, posture alignment, muscle thickness and shrinkage in neck pain patients. *Research hypothesis 1) Control group showed significant differences in pain level, dysfunction and posture alignment before and after experiment. 2) There will be significant differences in pain level, dysfunction, posture alignment, muscle thickness and shrinkage rate in the experimental group. 3) There will be a significant difference in pain level, dysfunction, posture alignment, muscle thickness and contraction rate between both groups. *Clinical research plan -This study is a pre-test post-test control group design. -In the neck pain patients who indicated voluntary participation, the center line of the ear for the selection of the subjects was more than 2.5 cm away from the center line of the acromion, craniovertebral angle (CVA) was 53 ° or less and the visual analog scale (VAS) was 3 or more. - Both groups measured pain levels (VAS), neck dysfunction index (NDI), posture alignment, muscle thickness and shrinkage before and after the experiment. - Both groups performed the scapula and thoracic stabilization exercise program and the lower trapezius strengthening exercise program in the experimental group. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Factorial |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Others (Lower trapezius strengthening exercise program) |
Intervention Description | - The scapular, thoracic stabilization and lower trapezius strengthening exercises were performed in the experimental group and the scapular and thoracic stabilization exercises were performed in the control group. To compare the pre-and post-experiment intervention effects, pre - and post - test were performed. - The scapular thoracic stabilization exercise program was performed in three sets of 10 times for 20 seconds, and the intervention was applied for 35 minutes / once, three times a week, and four weeks. - The lower trapezius strengthening exercise program was performed 10 times for 3 sets, and the intervention was applied for 30 minutes / once, 3 times a week, and 4 weeks. |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental group |
Target Number of Participant 20 |
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Arm Type Experimental |
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Arm Description - Scapular, thoracic stabilization exercise program We applied the scapula and thoracic stabilization exercise program, which was revised and supplemented by Cools et al. (2007). Exercise programs consisted of three exercise programs: scapula setting, upper temporomandibular stretching, and a thoracic extension exercise using a foam roller. Each exercise program, 20 sets of 10 times 3 sets, 20 seconds between the rest of the set. Each time the parking was increased, it was increased by 5 times, and the intervention was applied for 35 minutes / once, three times a week, and four weeks. - Lower trapezius strengthening exercise program The experimental program was supplemented with a lower trapezisu strengthening exercise program. Exercise programs consisted of modified prone cobra, trapezius muscle exercise progression, and wall slide. Each exercise program has 10 sets of 10 sets and 3 sets of sets and 20 seconds of set intervals. Each time the parking was increased, it was increased by 5 times, and the intervention was applied for a total of 30 minutes / once, three times a week, and four weeks. |
|
Arm 2 |
Arm Label control group |
Target Number of Participant 20 |
|
Arm Type Active comparator |
|
Arm Description - Scapular, thoracic stabilization exercise program We applied the scapula and thoracic stabilization exercise program, which was revised and supplemented by Cools et al. (2007). Exercise programs consisted of three exercise programs: scapula setting, upper temporomandibular stretching, and a thoracic extension exercise using a foam roller. Each exercise program, 20 sets of 10 times 3 sets, 20 seconds between the rest of the set. Each time the parking was increased, it was increased by 5 times, and the intervention was applied for 35 minutes / once, three times a week, and four weeks. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M54.22)Cervicalgia, cervical region The purpose of this study was to evaluate the outcome of the study. The criteria for participating in the experiment were that the center line of the outer ear of the ear was more than 2.5cm above the center line of the acromion There were no craniovertebral angle (CVA) of less than 53 °, a visual analogue scale (VAS) of 3 or more, and no congenital type of deformation. |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~65Year |
|
Description 1) The center line of the outer ear of the ear is more than 2.5 cm away from the center line of the shoulder bone peak. 2) a craniovertebral angle (CVA) of 53 ° or less 3) Pain level (visual analog scale, VAS) 3 or more points 4) Those who do not have the inherent type of deformation |
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Exclusion Criteria |
1) Those who have undergone orthopedic diagnosis on X-ray examination affecting the study 2) who have been diagnosed with traumatic neck injury 3) Those with a history of spinal bone or chest surgery 4) Those who participated in less than 70% of research mediation |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Pain level test - Explain that 0 means 'no pain', 5 means 'moderate pain', 10 means 'unimaginably severe pain', and measure the pain level at the time of measurement as a questionnaire |
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Timepoint | Immediately after the intervention |
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Primary Outcome(s) 2 | ||
Outcome | Posture Alignment - An angle formed by the line connecting the line connecting the line of the cervical vertebra with the line of the ear, the line joining the cervical vertebra (CVA), the line connecting the cervical vertebra with the ear, To measure the cranial rotation angle (CRA) |
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Timepoint | Immediately after the intervention |
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Primary Outcome(s) 3 | ||
Outcome | Muscle thickness and shrinkage - After restraining the cervical vertebra No. 7 and palpating the vertebra vertebrae, measure the resting position and contraction position of the muscle after the marking on the 8th thoracic vertebra. Shrinkage = (Thickness at contraction - Thickness at relaxation / Thickness at relaxation) * 100 Conversion |
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Timepoint | Immediately after the intervention |
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Secondary Outcome(s) 1 | ||
Outcome | Cervical dysfunction index - To quantify the physical discomfort in daily life caused by neck pain, a Korean version questionnaire was used to measure |
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Timepoint | Immediately after the intervention |
11. Study Results and Publication
Result Registered |
Yes
Results Upload |
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Final Enrollment Number | 40 |
Number of Publication | 0 |
Results Upload | 연구결과 - 박삼호.hwp |
Date of Posting Results | 2019/08/23 |
Protocol URL or File Upload | |
Brief Summary | 1) General characteristics of subjects - There were no significant differences in the variables such as gender, age, height, and weight between the two groups. 2) Comparison of pain levels before and after intervention There was no significant difference in pre - test between groups. Post - test showed that pain level was significantly decreased in both groups (p <.05). However, there was no significant difference between the two groups. 3) Comparison of disability level before and after intervention There was no significant difference in pre - test between groups. Post - test showed that both groups showed significant decrease in dysfunction level (p <.05). 4) Comparison of posture alignment before and after intervention There was no significant difference in pre-test between the two groups of the two vertebrae (CVA) and the cranial rotation angle (CRA), and post-test showed significant improvement in both groups (p <.05). In the group difference, both cervical vertebra (CVA) and cranial rotation angle (CRA) showed significant improvement in the experimental group (p <.05). 5) Comparison of muscle thickness and shrinkage before and after intervention There was no significant difference between the two groups in the pre - test. There was a significant difference in myocardial thickness only in the experimental group (p <.05), and there was no significant difference in relaxation muscle thickness between the two groups. There was also a significant difference between groups in the muscle thickness during contraction (p <.05) in the experimental group (p <.05) and in the experimental group (p <.05) in the muscle contraction. |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2019. 12 |
Way of Sharing | Available on Request
(samho15@naver.com) |
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