Status Approved
First Submitted Date
2019/11/12
Registered Date
2019/12/10
Last Updated Date
2019/12/04
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0004527 |
|---|---|
| Unique Protocol ID | 1041849-201901-BM-019-01 |
| Public/Brief Title | Effects of automatic spinal roller massage and thoracic extension exercise intervention for excessive thoracic kyphosis |
| Scientific Title | Effects of automatic spinal roller massage and thoracic extension exercise on spinal alignment, range of motion, respiratory function and body pressure distribution for excessive thoracic kyphosis |
| 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 |
|---|---|
| Board Approval Number | 1041849-201901-BM-019-01 |
| Approval Date | 2019-02-07 |
| Institutional Review Board Name | Yonsei University Wonju Institutional Review Board |
| Institutional Review Board Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do |
| Institutional Review Board Telephone | 033-760-5238 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | oh-yun Kwon |
| Title | Prof. |
| Telephone | +82-33-760-2427 |
| Affiliation | Yonsei University |
| Address | Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do, 26493, Korea |
| Contact Person for Public Queries | |
| Name | sung-hoon Jung |
| Title | Post Dr researcher |
| Telephone | +82-33-760-2971 |
| Affiliation | Yonsei University |
| Address | Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do, 26493, Korea |
| Contact Person for Updating Information | |
| Name | sung-hoon Jung |
| Title | Post Dr researcher |
| Telephone | +82-33-760-2971 |
| Affiliation | Yonsei University |
| Address | Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do, 26493, Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2019-03-11 Actual | |
| Target Number of Participant | 94 | |
| Primary Completion Date | 2019-09-23 , Actual | |
| Study Completion Date | 2019-09-23 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Yonsei University | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2019-03-11 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Yonsei University |
| Organization Type | University |
| Project ID | 2018-51-0477 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Yonsei University |
| Organization Type | University |
7. Study Summary
| Lay Summary | Individuals with more than 40 degrees of thoracic kyphosis is excessive thoracic kyphosis (hyperkyphosis). If you have an excessive thoracic kyphosis, that is, your back bends, the thoracic disc may be structurally compressed, and affect your breathing ability. It can also induce excessive protraction of head, creating a turtle neck posture, and diminishing the lumbar lordosis, causing lumbar disc protrusion. Therefore, many treatments such as thoracic extension exercise intervention were introduced to solve excessive thoracic curves. In addition, with the recent technology advances, spinal roller massage techniques with mechanical algorithms have been developed and are widely used to the general public. However, the effects of spinal roller massage and comparison with thoracic extension exercise intervention have not been studied. Therefore, the purpose of this study is to investigate the effects of automatic spinal roller massage and thoracic spinal exercise intervention and to identify the differences between the two effects. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Treatment |
| Phase | Not applicable |
| Intervention Model | Parallel |
| Blinding/Masking | Open |
| Allocation | RCT |
| Intervention Type | Others (automatic spinal roller massage, thoracic extension exercise intervention) |
| Intervention Description | The automatic spinal roller massage group is performed three times a week (30 minutes once a day) for eight weeks. The thoracic spinal exercise intervention group is performed to thoracic spinal exercise intervention three times a week (30 minutes per day) by an experienced physiotherapist at laboratory setting. The interventions involved back extensor muscle massage, thoracic joint mobilization, back extensor muscle exercise (muscle energy technique), and myofascial release, which were followed by F. kamali et al (2016). |
| Number of Arms | 2 |
| Arm 1 |
Arm Label automatic spinal roller massage group |
|
Target Number of Participant 19 |
|
|
Arm Type Experimental |
|
|
Arm Description three times a week (30 minutes once a day) for eight weeks |
|
| Arm 2 |
Arm Label back extension exercise interventions group |
|
Target Number of Participant 16 |
|
|
Arm Type Experimental |
|
|
Arm Description The interventions involved back extensor muscle massage, thoracic joint mobilization, back extensor muscle exercise (muscle energy technique), and myofascial release, which were followed below. Massage: With the participant in the prone position, the physiotherapist applied wringing and skin rolling massage to the back extensor muscles Myofascial release: The therapist applied gentle sustained pressure, and then moved both hands in opposite directions and held the stretch at the extension barrier until release occurred. Mobilization: The therapist placed the medial border of her hand on each spinous process of the thoracic vertebrae and applied downward pressure toward thoracic extension. Muscle energy: The patient was asked to sit in a relaxed position with both hands on her neck. Her upper arms were supporting on the therapist’s arm. The therapist’s other hand was placed on the spinous process of the thoracic vertebra in order to move the vertebra to the end of the extension barrier. Then, the participant was instructed to push her elbows toward flexion no more than 25% of her maximum contraction. The therapist resisted her effort for 5–7 seconds. When the patient ceased the effort, the therapist moved the vertebra further into extension. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M43.94)Deforming dorsopathy, unspecified, thoracic region thoracic hyperkyphosis |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 20Year~50Year |
|
|
Description thoracic kyphosis angle greater than 40 degrees |
|
| Exclusion Criteria |
scoliosis; a history of spinal column fracture; spinal tumors and related malignancies; congenital spinal anomalies; cancer; and rheumatoid arthritis |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | Not applicable | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | thoracic kyphosis in standing posture |
|
| Timepoint | pre-post intervention |
|
| Primary Outcome(s) 2 | ||
| Outcome | thoracic kyphosis in extension |
|
| Timepoint | pre-post intervention |
|
| Primary Outcome(s) 3 | ||
| Outcome | lumbar lordosis in standing posture |
|
| Timepoint | pre-post intervention |
|
| Primary Outcome(s) 4 | ||
| Outcome | lumbar lordosis in extension |
|
| Timepoint | pre-post intervention |
|
| Primary Outcome(s) 5 | ||
| Outcome | electromyography of erector spinae |
|
| Timepoint | pre-post intervention |
|
| Primary Outcome(s) 6 | ||
| Outcome | strength of thoracic extension |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 1 | ||
| Outcome | cervical lordosis |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 2 | ||
| Outcome | head position in supine |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 3 | ||
| Outcome | deep neck flexion angle |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 4 | ||
| Outcome | forward head position |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 5 | ||
| Outcome | scapular ratio |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 6 | ||
| Outcome | pressure pain threshold |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 7 | ||
| Outcome | diaphragm movement during inspiration |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 8 | ||
| Outcome | forced volume capacity |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 9 | ||
| Outcome | forced expiratory voulme in one second |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 10 | ||
| Outcome | peak expiratory flow |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 11 | ||
| Outcome | pain questionnaire |
|
| Timepoint | pre-post intervention |
|
| Secondary Outcome(s) 12 | ||
| Outcome | sleep questionnaire |
|
| Timepoint | pre-post intervention |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Yes |
|---|---|
| Time of Sharing | 2021. 12 |
| Way of Sharing | Available on Request
(movt_architect@daum.net) |
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