NCT05996341

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

July 27, 2023

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

Study Arms (3)

LBPADIM_BFR group

EXPERIMENTAL

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.

Device: blood flow restriction

LBPADIM_shan BFR group

PLACEBO COMPARATOR

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.

Device: blood flow restriction

HealthyADIM_BFR group

EXPERIMENTAL

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.

Device: blood flow restriction

Interventions

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

Also known as: Delfi's Personalized Tourniquet System
HealthyADIM_BFR groupLBPADIM_BFR groupLBPADIM_shan BFR group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Stress fracture
  • osteoporosis
  • acute lower back pain
  • Spinal tumor
  • spinal canal narrowing
  • spinal osteitis
  • spinal meningitis
  • vertebral slippage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy of China Medical University

Taichung, Test2, test3, Taiwan

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

yan-zhang Li

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 18, 2023

Study Start

January 1, 2024

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations