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

NCT ID: NCT05996341

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-02-29

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.

Conditions

Non-specific Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LBPADIM_BFR group

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.

Group Type: EXPERIMENTAL

blood flow restriction

Intervention Type: DEVICE

12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg

LBPADIM_shan BFR group

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.

Group Type: PLACEBO_COMPARATOR

blood flow restriction

Intervention Type: DEVICE

12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg

HealthyADIM_BFR group

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.

Group Type: EXPERIMENTAL

blood flow restriction

Intervention Type: DEVICE

12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg

Interventions

blood flow restriction

12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg

Intervention Type: DEVICE

Other Intervention Names

Delfi's Personalized Tourniquet System

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Physical Therapy of China Medical University

Taichung, Test2, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yueh-Ling Hsieh

Role: CONTACT

Phone: 04-22053366

Email: sherrie@mail.cmu.edu.tw

yan-zhang Li

Role: CONTACT

Phone: 0917805895

Facility Contacts

Yueh-Ling Hsieh, PHD

Role: primary

Other Identifiers

CMUH111-REC2-221

Identifier Type: -

Identifier Source: org_study_id