Non-specific Low Back PainNCT05996341
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
A study testing blood flow restriction in people with Non-specific Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- blood flow restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2024to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Stress fracture
- osteoporosis
- acute lower back pain
- Spinal tumor
- spinal canal narrowing
- spinal osteitis
- spinal meningitis
- vertebral slippage
Trial locations and contacts
1 site in 1 country.
yan-zhang Li contact
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy of China Medical University
Taichung, Test2, test3
Yueh-Ling Hsieh, PHD, 04-22053366 ext. 7312, sherrie@mail.cmu.edu.tw
About this study
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.
Read the 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
- Being tested
- blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restrictionDevice
Also called Delfi's Personalized Tourniquet System
12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study startJan 2024 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996341
- Sponsor's protocol ID
- CMUH111-REC2-221
- Status last verified
- Dec 2023
- First submitted
- 27 Jul 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05996341
- Acronym / sponsor ID
- CMUH111-REC2-221
- Conditions
- Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LBPADIM_BFR group | Experimental | Device: blood flow restrictionRecipient 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. |
| LBPADIM_shan BFR group | Placebo comparator | Device: blood flow restrictionThe 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. |
| HealthyADIM_BFR group | Experimental | Device: blood flow restrictionTested 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Stress fracture
- osteoporosis
- acute lower back pain
- Spinal tumor
- spinal canal narrowing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood flow restrictionAlso: Delfi's Personalized Tourniquet System12 lower ribs and upper rechargeable nylon ribs (84 cm long, 14 cm long) Points), recharge to 160mmHg | Device | HealthyADIM_BFR group, LBPADIM_BFR group, LBPADIM_shan BFR group |
Primary outcome
Muscle thickness
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yan-zhang Li contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood flow restriction in people with Non-specific Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Ling Hsieh (04-22053366 ext. #7312, sherrie@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle thickness (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.