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Differences in abdominal muscles activation on the positions of pelvis and application of vibration during sling bridge exercise in individuals with and without low back pain

Status Approved

First Submitted Date

2020/04/14
Registered Date

2020/05/20
Last Updated Date

2020/04/14

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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	KCT0005043
Unique Protocol ID	2020AN0142
Public/Brief Title	Differences in abdominal muscles activation on the positions of pelvis and application of vibration during sling bridge exercise in individuals with and without low back pain
Scientific Title	Differences in abdominal muscles activation on the positions of pelvis and application of vibration during sling bridge exercise in individuals with and without low back 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	2020AN0142
Approval Date	2020-04-06
Institutional Review Board Name	Korea University Anam Hospital Ethical Review Board
Institutional Review Board Address	73, Korea University-ro, Seongbuk-gu, Seoul
Institutional Review Board Telephone	02-920-6566
Data Monitoring Committee	No

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	Seungmin Kim
Title	physical therapist
Telephone	+82-2-920-6485
Affiliation	Korea University
Address	Korea University Medicine, 73, Goryeodae-ro Seong buk-gu, Seoul
Contact Person for Public Queries
Name	Seungmin Kim
Title	physical therapist
Telephone	+82-2-920-6485
Affiliation	Korea University
Address	Korea University Medicine, 73, Goryeodae-ro Seong buk-gu, Seoul
Contact Person for Updating Information
Name	Seungmin Kim
Title	physical therapist
Telephone	+82-2-920-6485
Affiliation	Korea University
Address	Korea University Medicine, 73, Goryeodae-ro Seong buk-gu, Seoul

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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-04-10 Actual
Target Number of Participant	60
Primary Completion Date	2021-03-31 , Anticipated
Study Completion Date	2021-03-31 , Anticipated
Name of Study	Korea University Anam Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-04-10 ,

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	Korea University Anam Hospital
Organization Type	Medical Institute
Project ID	2020AN0142

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea University Anam Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Chronic back pain is caused by instability in the spine due to muscle weakness around the spine, damage to soft tissues in the trunk, and degenerative changes in trunk muscle endurance. In the normal case, when the lower limb moves, the lumbo-pelvic stabilization muscle is involuntarily mobilized first, whereas in the low back pain patients with instability, the lumbar stabilization muscle appears late. The stabilizing muscles for the stability of the trunk include the multifidus muscle, the transverse abdominis muscle, the pelvic floor muscles, the diaphragm muscle, and the thoracolumbar fascia. Therefore, evaluation for lumbar instability is a very important factor in judging the proper treatment and prognosis of patients with low back pain. Recently, among the studies on posture and movement control, studies related to stabilization of the lumbar region or stabilization of the trunk have been receiving attention. The trunk stabilization exercise is a muscle strengthening exercise of the local muscle group located in the deep part of the trunk around the lumbar region, which plays an important role in providing dynamic stability of the spinal segment, and is a useful exercise to reduce dysfunction due to instability of the spine. In order to effectively activate the transverse abdominal muscle, studies of using tools such as a ball or a sling in various postures have been attempted for normal and patient groups. In particular, Saliba et al. suggested that the activation of the transverse abdominis muscle was the most pronounced during the bridge exercise including various elements that spread the legs in various bridge exercises using the sling. In addition, the application of vibration during bridge exercise will be able to expect greater activity of the abdominal muscles by inducing an increase in load as well as stimulation of the proprioceptive sensation. However, studies that quantify the effects of the application of pelvic position and vibration during bridge exercise using a sling through ultrasound studies are insufficient, so we intend to confirm clinical effectiveness through this study.

Study Summary Information

Lay Summary

Chronic back pain is caused by instability in the spine due to muscle weakness around the spine, damage to soft tissues in the trunk, and degenerative changes in trunk muscle endurance. In the normal case, when the lower limb moves, the lumbo-pelvic stabilization muscle is involuntarily mobilized first, whereas in the low back pain patients with instability, the lumbar stabilization muscle appears late. The stabilizing muscles for the stability of the trunk include the multifidus muscle, the transverse abdominis muscle, the pelvic floor muscles, the diaphragm muscle, and the thoracolumbar fascia. Therefore, evaluation for lumbar instability is a very important factor in judging the proper treatment and prognosis of patients with low back pain.
Recently, among the studies on posture and movement control, studies related to stabilization of the lumbar region or stabilization of the trunk have been receiving attention. The trunk stabilization exercise is a muscle strengthening exercise of the local muscle group located in the deep part of the trunk around the lumbar region, which plays an important role in providing dynamic stability of the spinal segment, and is a useful exercise to reduce dysfunction due to instability of the spine.
In order to effectively activate the transverse abdominal muscle, studies of using tools such as a ball or a sling in various postures have been attempted for normal and patient groups. In particular, Saliba et al. suggested that the activation of the transverse abdominis muscle was the most pronounced during the bridge exercise including various elements that spread the legs in various bridge exercises using the sling. In addition, the application of vibration during bridge exercise will be able to expect greater activity of the abdominal muscles by inducing an increase in load as well as stimulation of the proprioceptive sensation.
However, studies that quantify the effects of the application of pelvic position and vibration during bridge exercise using a sling through ultrasound studies are insufficient, so we intend to confirm clinical effectiveness through this study.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-control
Time Perspective	Cross-sectional
Target Number of Participant	60
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label individuals without low back pain
Cohort/ Group 1	Cohort/Group Description The activity rate of the transverse abdominal muscle, the internal oblique abdominal muscle, and the external oblique abdominal muscle during sling bridge exercise
Cohort/ Group 2	Cohort/Group Label individuals with low back pain
Cohort/ Group 2	Cohort/Group Description The activity rate of the transverse abdominal muscle, the internal oblique abdominal muscle, and the external oblique abdominal muscle during sling bridge exercise
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	individuals with and without low back pain who visit the Dept. of rehabilitation medicine of Korea University Anam Hospital
Sampling Method	simple random sampling
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M54.56)Low back pain, lumbar region Those who meet M54 (lower back pain) in ICD-10 and individuals without low back pain for 3 months
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~70Year
	Description 1) Normal group - No low back pain in 3 months 2) Low back pain group - Those who understand the contents of the research and voluntarily participate and agree - Pain Index VAS (Visual Analog Scale) 20mm more and over 20 years old and under 70 years old - pain lasting more than 3 months - ODI(oswestry disability index) > 20% - Those who meet M54 (lower back pain) in ICD-10
Exclusion Criteria	- people who have experienced traffic accidents in the last 3 months - people with acute back pain - people with vascular disorders around the abdomen and lumbar region - people with advanced neurological disorders - persons who are contraindicated in physical therapy examination and treatment (fractures, severe trauma, infection, cancer, rheumatoid myelitis, spinal cord or mammary disease, etc.) - pregnant woman
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Rate of change in thickness of the abdominal muscle
Timepoint	Initial measurement time
Primary Outcome(s) 2
Outcome	Rate of change in thickness of internal oblique muscle
Timepoint	Initial measurement time
Primary Outcome(s) 3
Outcome	Rate of change in thickness of external oblique muscle
Timepoint	Initial measurement time
Secondary Outcome(s) 1
Outcome	Oswestry Disability Index
Timepoint	Initial measurement time

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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