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The Effects of Blood Flow Restriction-based Abdominal draw-in Maneuver on Activation of Abdominal Core Muscles in Patients With Non-specific Low Back Pain

Primary Purpose

Non-specific Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
blood flow restriction
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Low Back Pain

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Confirm that it is caused by pathological and mental stress or illness Non-idiopathic low back pain persistent or intermittent pain for more than six weeks the pain index of the scale, number is between 2 and 10 points. Exclusion Criteria: Stress fracture osteoporosis acute lower back pain Spinal tumor spinal canal narrowing spinal osteitis spinal meningitis vertebral slippage

Sites / Locations

  • Department of Physical Therapy of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

LBPADIM_BFR group

LBPADIM_shan BFR group

HealthyADIM_BFR group

Arm Description

Recipient No. 12 lower ribs and upper rechargeable nylon ribs , charge to 160mmHg and do ADIM at the same time and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once. The total number of intervention was 20 minutes, once a time, a total of 4 minutes.

The recipient has a rechargeable nylon rib under the 12th rib , but it is not filled and does not cause abdominal muscle BFR, which is used as the BFR of abdominal muscle. At the same time, we also do ADIM authentication,and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once. The total number of intervention was 20 minutes, once a time, a total of 4 minutes.

Tested The top rechargeable nylon under the 12th rib , charge to 160mmHg and do ADIM password at the same time, and tand retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once. The total number of intervention was 20 minutes, once a time, a total of 4 minutes.

Outcomes

Primary Outcome Measures

Muscle thickness
In this study, abdominal muscles were evaluated by Brightness-mode, 5M-Hz, Linear). The thickness of meat during abdominal muscle relaxation and during draw-in. The probing position is located at the lowest end of the rib and in the middle of the iliac spine. At the midpoint of the axillary line. Put an ultrasonic image of the abdominal muscle in the abdominal muscle and vomit in ADIM. At the end of the day, we take an image. Then calculate the muscle thickness. The calculation standard is from the tail and abdomen of TrA The fascia joint tip is three centimeters inward, and the muscle thickness of transvers abdominal, internal oblique and external oblique muscle is calculated from bottom to top, and Total muscle thickness, measured in centimeters (cm).

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
August 16, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05996341
Brief Title
The Effects of Blood Flow Restriction-based Abdominal draw-in Maneuver on Activation of Abdominal Core Muscles in Patients With Non-specific Low Back Pain
Official Title
The Effects of Blood Flow Restriction-based Abdominal draw-in Maneuver on Activation of Abdominal Core Muscles in Patients With Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The transverse abdominis (TrA) is the deepest muscle layer of lateral and anterior abdominal wall and also known as a significant component of core stability. Abdominal draw-in maneuver (ADIM) is the main for the strengthening of the deep muscle, however, sufficient activation of TrA by ADIM is limited. Blood flow restriction (BFR) training is a technique combined with low intensity exercise that produces similar results to high intensity training. Therefore, the purpose of this study is to explore whether BFR-assisted ADIM can become a new auxiliary way to train TrA, and whether it can better activate their TrA in patients with low back pain. Low back pain (LBP) is a major health problem with huge economic and social costs. Core muscle weakness is a risk factor for LBP. Past studies have also pointed out that the biggest cause affecting the quality of life and activities of modern people is lower back pain. In modern life, low back pain can be said to be a very common disease. According to past research, there is a 50% to 70% chance that people may have lower back pain in their lifetime, and non-specific low back pain accounts for the majority (90%), the reason why the influence of non-specific low back pain is so great is not only physically but also psychologically. When people perform many functions of daily life, people need the help of the waist. But once the wrong way of effort or posture will lead to more pressure on the spine, leading to greater pain, a strong sense of discomfort will haunt them for a long time. Therefore, the activation and control of TrA is very important because of the relationship between the lateral direction of TrA, so when TrA contracts, it will result in a decrease in waist circumference, an increase in thoracolumbar fascia tension and an increase in intra-abdominal pressure, so it is regarded as the most important stable muscle in the core.In addition, TrA is a special presence in the core muscle group, it can independently contract and like the presence of waist protection to stabilize our spine, but because it is located in the deepest layer, coupled with less muscle activity, it is difficult to effectively activate correctly, so if TrA is not activated or contracted correctly, it may cause non-specific lower back pain.
Detailed Description
In this study, 20 healthy people and 20 patients with lower back pain were recruited and divided into healthy group, experimental group (patients with lower back pain) and sham experimental group (patients with lower back pain). The subjects in the experimental group and the healthy group were tied under the ribs with a pulse band (14 cm wide and 84 cm long) to block at least 60% of the blood flow and do abdominal exercise. In the sham experimental group, the ventral compression band was fastened but the abdominal contraction exercise was performed without inflation. Each subject exercised for 20 minutes twice a week for six weeks. At the first, third and sixth week, ultrasound (Ultrasound, USD) was used to evaluate the muscle thickness and muscle activation of external oblique muscle, internal oblique muscle and transverse muscle (core muscle group). This study expects that blood blocking training can increase the degree of activation, muscle strength and hypertrophy of transverse abdominal muscle in patients with lower back pain, and can provide a new auxiliary method to improve the predicament that it is difficult to activate transverse abdominal muscle correctly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LBPADIM_BFR group
Arm Type
Experimental
Arm Description
Recipient No. 12 lower ribs and upper rechargeable nylon ribs , charge to 160mmHg and do ADIM at the same time and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once. The total number of intervention was 20 minutes, once a time, a total of 4 minutes.
Arm Title
LBPADIM_shan BFR group
Arm Type
Placebo Comparator
Arm Description
The recipient has a rechargeable nylon rib under the 12th rib , but it is not filled and does not cause abdominal muscle BFR, which is used as the BFR of abdominal muscle. At the same time, we also do ADIM authentication,and retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once. The total number of intervention was 20 minutes, once a time, a total of 4 minutes.
Arm Title
HealthyADIM_BFR group
Arm Type
Experimental
Arm Description
Tested The top rechargeable nylon under the 12th rib , charge to 160mmHg and do ADIM password at the same time, and tand retract the abdominal muscles and let the belly fold inward and upward toward the spine and hold for 10 seconds, once. The total number of intervention was 20 minutes, once a time, a total of 4 minutes.
Intervention Type
Device
Intervention Name(s)
blood flow restriction
Other Intervention Name(s)
Delfi's Personalized Tourniquet System
Intervention Description
12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg
Primary Outcome Measure Information:
Title
Muscle thickness
Description
In this study, abdominal muscles were evaluated by Brightness-mode, 5M-Hz, Linear). The thickness of meat during abdominal muscle relaxation and during draw-in. The probing position is located at the lowest end of the rib and in the middle of the iliac spine. At the midpoint of the axillary line. Put an ultrasonic image of the abdominal muscle in the abdominal muscle and vomit in ADIM. At the end of the day, we take an image. Then calculate the muscle thickness. The calculation standard is from the tail and abdomen of TrA The fascia joint tip is three centimeters inward, and the muscle thickness of transvers abdominal, internal oblique and external oblique muscle is calculated from bottom to top, and Total muscle thickness, measured in centimeters (cm).
Time Frame
The experiment was conducted for a total of five weeks.After the first ultrasonic image estimation and the fourth week, all the assessments are carried out again, and then tracked down in the fifth week. Estimate.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Confirm that it is caused by pathological and mental stress or illness Non-idiopathic low back pain persistent or intermittent pain for more than six weeks the pain index of the scale, number is between 2 and 10 points. Exclusion Criteria: Stress fracture osteoporosis acute lower back pain Spinal tumor spinal canal narrowing spinal osteitis spinal meningitis vertebral slippage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yueh-Ling Hsieh
Phone
04-22053366
Ext
#7312
Email
sherrie@mail.cmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
yan-zhang Li
Phone
0917805895
Facility Information:
Facility Name
Department of Physical Therapy of China Medical University
City
Taichung
State/Province
Test2
ZIP/Postal Code
test3
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueh-Ling Hsieh, PHD
Phone
04-22053366
Ext
7312
Email
sherrie@mail.cmu.edu.tw

12. IPD Sharing Statement

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The Effects of Blood Flow Restriction-based Abdominal draw-in Maneuver on Activation of Abdominal Core Muscles in Patients With Non-specific Low Back Pain

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