Lumbar Disc HerniationNCT04859712
A Diagnostic Test of Abnormal Sound Waves in Modern Pulsology of Lumbar Disc Herniation
An observational study of Lumbar Disc Herniation and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The purpose of this study is to use the " Pulse Detection System of Sound Waves " to collect the pulse information of recruited subjects, and to extract characteristic pulse information by multi-scale entropy, Fourier transform, Hilbert yellow transform, spectrum analysis, wavelet analysis and other methods. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Radial Artery
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2021to 25 Apr 2022
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with lumbar disc herniation and relatively healthy people
Who may be able to join
- Trial group
- Study time: March 9, 2021, to March 9, 2022 ;
- Study site: The First Affiliated Hospital of Shandong First Medical University;
- Patients with lumbar disc herniation who have not undergone lumbar surgery and who meet the diagnostic gold standard of symptoms, signs and imaging examinations should be comprehensively assessed.;
- Patients who were first diagnosed with lumbar disc herniation less than 4 months ago;
- Patients with a range of ages of 20-50 years and stable vital signs;
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- Patients who have informed consent to receive the pulse collection;
- control group
- Study time: March 9, 2021, to March 9, 2022 ;
- Study site: The First Affiliated Hospital of Shandong First Medical University;
- Relatively healthy people without lumbar disc herniation diagnosis;
- Patients with a range of ages of 20-50 years and stable vital signs;
- Patients who have informed consent to accept the pulse collection;
Who cannot join
- Trial group
- Patients with lumbar spinal stenosis, lumbar tuberculosis, vertebral metastases, nerve root and cauda equina tumors, hip osteoarthropathy or aseptic necrosis of the femoral head, piriformis syndrome, ankylosing spondylitis, herpes zoster and other lumbar diseases;
- Patients with diseases of the urinary system and reproductive system;
- Patients who have undergone lumbar disc surgery;
- Pregnant or lactating women;
- Patients with other thoracic diseases;
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- Patients with gallbladder, pancreas and other diseases adjacent to the liver;
- Patients with severe infectious diseases;
- Those who are not easy to collect pulse manifestation such as pulse on back of wrist and oblique-running pulse;
- Incomplete data due to subjective or objective reasons affect the judgment of results;
- Patients with Parkinson's disease or other limb tremor;
- Patients with atrial fibrillation.
- control group
- Patients with lumbar disc herniation;
- Patients suffering from lumbar tuberculosis, ankylosing spondylitis and other serious diseases and difficult to maintain posture for a certain period of time;
- Pregnant or lactating women;
- Patients with severe infectious diseases;
- Those who are not easy to collect pulse manifestation such as pulse on back of wrist and oblique-running pulse;
- Incomplete data due to subjective or objective reasons affect the judgment of results;
- Patients with Parkinson's disease or other limb tremor;
- Patients with atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250014
Lili Cao, PH.D, qykyc309@163.com
Lucheng Song, PH.D
About this study
The purpose of this study is to use the " Pulse Detection System of Sound Waves " to collect the pulse information of recruited subjects, and to extract characteristic pulse information by multi-scale entropy, Fourier transform, Hilbert yellow transform, spectrum analysis, wavelet analysis and other methods. Evaluate the specificity, sensitivity, positive likelihood ratio and negative likelihood ratio of the "Pulse Detection System of Sound Waves" in the diagnosis of lumbar disc herniation.
Read the detailed description
Pulse diagnosis is an important method to judge the status of patients in the process of diagnosis and treatment of traditional Chinese medicine. At present, the commonly used site of pulse diagnosis is the radial artery, which is divided into "cun", "guan" and "chi". Whether the diagnosis of lumbar disc herniation can be realized through pulse diagnosis has not been solved. Herniation of the lumbar intervertebral disc is a syndrome caused by degeneration of intervertebral disc, partial or complete rupture of the annulus fibrosus, protrusion of nucleus pulposus, or compression of nerve roots and cauda equina. In the area of compression, the blood supply is also limited to a certain extent, and the blood that should be in the normal laminar flow state gradually turns into a turbulent state, causing abnormal vibration, which is fused with a larger cluster of sound waves transmitted by the heart and then transmitted throughout the body. In this situation, the investigators can feel the combination of abnormal vibration waves by touching the pulse at different levels of the arteries near the surface of the body, including the radial artery. In long-term clinical practice, the investigators have found that the ulnar radial pulse of patients with lumbar disc herniation, i.e. the fifth layer of the ulnar radial pulse, often presents an unsmooth pulse. Therefore, the investigators believe that patients with lumbar disc herniation may have abnormal sound waves in the radial artery.
The investigators have found that there are low-frequency sound waves in the radial artery, which carry the physiological and pathological information of the organs in the body, and developed the "Pulse Detection System of Sound Waves". Previous projects have achieved certain results after exploring the abnormal sound waves of the radial artery in patients with sequelae of cerebral infarction, stable coronary heart disease, chronic gastritis and other diseases.
Therefore, this study will use the "Pulse Detection System of Sound Waves" to collect the sound waves in the radial artery of both hands from 45 patients with lumbar disc herniation and 45 relatively healthy people and carry out spectrum analysis and wavelet analysis to extract the pulse characteristics. The sensitivity and specificity of "Pulse Detection System of Sound Waves" in the diagnosis of lumbar disc herniation will be calculated. Supposed there are characteristic sound waves in the radial artery of patients with lumbar disc herniation, and these characteristic sound waves have some specific distributions, planes, and points that are different from the sound waves of relatively healthy persons. Then this study will explore and gradually confirm such characteristics and differences. It is expected to contribute to the pulse diagnosis of lumbar disc herniation.
- Conditions
- Lumbar Disc Herniation, Radial Artery
- Keywords
- Diagnostic Test, Lumbar Disc Herniation, Radial Artery
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trial group: 45 patients with lumbar disc herniation | The "Pulse Detection System of Sound Waves " was used to collect three parts and five layers of pulsed sound waves from the hands of 45 patients with lumbar disc herniation. | |
| Control group :45 relatively healthy people | The "Pulse Detection System of Sound Waves " was used to collect the three-parts and five-layers pulse sound waves of the hands of 45 relatively healthy people. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of abnormal sound waves in the pulses.
Using the Pulse Detection System of Sound Waves (PDSSW) to collect the pulse waves of both hands. The percentage(%) of Frequencies of abnormal sound waves in the pulse will be calculated.
Measured: The data will be collected, analyzed and calculated in about 7 days.
The changes of sound waves in the pulses.
The changes of sound waves at different Hertz (Hz) frequencies and SMPL amplitudes will be compared between patients with lumbar disc herniation and relatively healthy individuals.
Measured: The discovery of characteristic sound waves may take 3 months.
Diagnostic test
The percentage (%) of specificity, sensitivity, positive likelihood ratio and negative likelihood ratio of the "Pulse Detection System of Sound Waves" in the diagnosis of patients with lumbar disc herniation.
Measured: Diagnostic tests may take about 1 month.
Sound waves analysis
The Hertz (Hz) of the different segments of the sound waves in Wavelet transform.
The Hertz (Hz) of the different layers of the sound waves in Hilbert-Huang. The SMPL amplitudes of the sound waves in Discrete Fourier Transform. The sampEn of sound waves in Sample Entropy.
Measured: 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start9 Apr 2021
- Primary completion25 Apr 2022 (estimated)
- Study completion25 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Lucheng Song, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859712
- Sponsor's protocol ID
- SFUYIN-03
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rickers KW, Pedersen PH, Tvedebrink T, Eiskjaer SP. Comparison of interventions for lumbar disc herniation: a systematic review with network meta-analysis. Spine J. 2021 Oct;21(10):1750-1762. doi: 10.1016/j.spinee.2021.02.022. Epub 2021 Mar 3.
PubMed 33667683Ishitani H, Tamura T, Kanaya S, Fujimoto H. Examination of the regression model to quantify the degree of low back pain and lower limb symptoms in patients with lumbar disc herniation by the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). PLoS One. 2020 Dec 14;15(12):e0243861. doi: 10.1371/journal.pone.0243861. eCollection 2020.
PubMed 33315945Siccoli A, Schroder ML, Staartjes VE. Association of age with incidence and timing of recurrence after microdiscectomy for lumbar disc herniation. Eur Spine J. 2021 Apr;30(4):893-898. doi: 10.1007/s00586-020-06692-1. Epub 2020 Dec 14.
PubMed 33315158Bilton K, Hammer L, Zaslawski C. Contemporary Chinese pulse diagnosis: a modern interpretation of an ancient and traditional method. J Acupunct Meridian Stud. 2013 Oct;6(5):227-33. doi: 10.1016/j.jams.2013.04.002. Epub 2013 Apr 24.
PubMed 24139459Shimony N, Louie C, Barrow D, Osburn B, Noureldine MHA, Tuite GF, Carey CM, Jallo GI, Rodriguez L. Adolescent Disc Disease: Risk Factors and Treatment Success-Related Factors. World Neurosurg. 2021 Apr;148:e314-e320. doi: 10.1016/j.wneu.2020.12.126. Epub 2021 Jan 4.
PubMed 33412329
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Test of Abnormal Sound Waves in Modern Pulsology of Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT04859712
- Acronym / sponsor ID
- SFUYIN-03
- Conditions
- Lumbar Disc Herniation, Radial Artery
- Keywords
- Diagnostic Test, Lumbar Disc Herniation, Radial Artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 25 Apr 2022 (estimated)
- Study completion
- 25 Apr 2022 (estimated)
- First posted
- 26 Apr 2021 (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 purpose of this study is to use the " Pulse Detection System of Sound Waves " to collect the pulse information of recruited subjects, and to extract characteristic pulse information by multi-scale entropy, Fourier transform, Hilbert yellow transform, spectrum analysis, wavelet analysis and other methods. Evaluate the specificity, sensitivity, positive likelihood ratio and negative likelihood ratio of the "Pulse Detection System of Sound Waves" in the diagnosis of lumbar disc herniation.
Detailed description
Pulse diagnosis is an important method to judge the status of patients in the process of diagnosis and treatment of traditional Chinese medicine. At present, the commonly used site of pulse diagnosis is the radial artery, which is divided into "cun", "guan" and "chi". Whether the diagnosis of lumbar disc herniation can be realized through pulse diagnosis has not been solved. Herniation of the lumbar intervertebral disc is a syndrome caused by degeneration of intervertebral disc, partial or complete rupture of the annulus fibrosus, protrusion of nucleus pulposus, or compression of nerve roots and cauda equina. In the area of compression, the blood supply is also limited to a certain extent, and the blood that should be in the normal laminar flow state gradually turns into a turbulent state, causing abnormal vibration, which is fused with a larger cluster of sound waves transmitted by the heart and then transmitted throughout the body. In this situation, the investigators can feel the combination of abnormal vibration waves by touching the pulse at different levels of the arteries near the surface of the body, including the radial artery. In long-term clinical practice, the investigators have found that the ulnar radial pulse of patients with lumbar disc herniation, i.e. the fifth layer of the ulnar radial pulse, often presents an unsmooth pulse. Therefore, the investigators believe that patients with lumbar disc herniation may have abnormal sound waves in the radial artery.
The investigators have found that there are low-frequency sound waves in the radial artery, which carry the physiological and pathological information of the organs in the body, and developed the "Pulse Detection System of Sound Waves". Previous projects have achieved certain results after exploring the abnormal sound waves of the radial artery in patients with sequelae of cerebral infarction, stable coronary heart disease, chronic gastritis and other diseases.
Therefore, this study will use the "Pulse Detection System of Sound Waves" to collect the sound waves in the radial artery of both hands from 45 patients with lumbar disc herniation and 45 relatively healthy people and carry out spectrum analysis and wavelet analysis to extract the pulse characteristics. The sensitivity and specificity of "Pulse Detection System of Sound Waves" in the diagnosis of lumbar disc herniation will be calculated. Supposed there are characteristic sound waves in the radial artery of patients with lumbar disc herniation, and these characteristic sound waves have some specific distributions, planes, and points that are different from the sound waves of relatively healthy persons. Then this study will explore and gradually confirm such characteristics and differences. It is expected to contribute to the pulse diagnosis of lumbar disc herniation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group: 45 patients with lumbar disc herniation | – | –The "Pulse Detection System of Sound Waves " was used to collect three parts and five layers of pulsed sound waves from the hands of 45 patients with lumbar disc herniation. |
| Control group :45 relatively healthy people | – | –The "Pulse Detection System of Sound Waves " was used to collect the three-parts and five-layers pulse sound waves of the hands of 45 relatively healthy people. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with lumbar disc herniation and relatively healthy people
Key inclusion criteria (13 listed)
- Trial group
- Study time: March 9, 2021, to March 9, 2022 ;
- Study site: The First Affiliated Hospital of Shandong First Medical University;
- Patients with lumbar disc herniation who have not undergone lumbar surgery and who meet the diagnostic gold standard of symptoms, signs and imaging examinations should be comprehensively assessed.;
- Patients who were first diagnosed with lumbar disc herniation less than 4 months ago;
Key exclusion criteria (21 listed)
- Trial group
- Patients with lumbar spinal stenosis, lumbar tuberculosis, vertebral metastases, nerve root and cauda equina tumors, hip osteoarthropathy or aseptic necrosis of the femoral head, piriformis syndrome, ankylosing spondylitis, herpes zoster and other lumbar diseases;
- Patients with diseases of the urinary system and reproductive system;
- Patients who have undergone lumbar disc surgery;
- Pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequencies of abnormal sound waves in the pulses.
Time frame: The data will be collected, analyzed and calculated in about 7 days.
Using the Pulse Detection System of Sound Waves (PDSSW) to collect the pulse waves of both hands. The percentage(%) of Frequencies of abnormal sound waves in the pulse will be calculated.
The changes of sound waves in the pulses.
Time frame: The discovery of characteristic sound waves may take 3 months.
The changes of sound waves at different Hertz (Hz) frequencies and SMPL amplitudes will be compared between patients with lumbar disc herniation and relatively healthy individuals.
Diagnostic test
Time frame: Diagnostic tests may take about 1 month.
The percentage (%) of specificity, sensitivity, positive likelihood ratio and negative likelihood ratio of the "Pulse Detection System of Sound Waves" in the diagnosis of patients with lumbar disc herniation.
Sound waves analysis
Time frame: 1 month.
The Hertz (Hz) of the different segments of the sound waves in Wavelet transform. The Hertz (Hz) of the different layers of the sound waves in Hilbert-Huang. The SMPL amplitudes of the sound waves in Discrete Fourier Transform. The sampEn of sound waves in Sample Entropy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 33667683Rickers KW, Pedersen PH, Tvedebrink T, Eiskjaer SP. Comparison of interventions for lumbar disc herniation: a systematic review with network meta-analysis. Spine J. 2021 Oct;21(10):1750-1762. doi: 10.1016/j.spinee.2021.02.022. Epub 2021 Mar 3.
- Background: PubMed 33315945Ishitani H, Tamura T, Kanaya S, Fujimoto H. Examination of the regression model to quantify the degree of low back pain and lower limb symptoms in patients with lumbar disc herniation by the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). PLoS One. 2020 Dec 14;15(12):e0243861. doi: 10.1371/journal.pone.0243861. eCollection 2020.
- Background: PubMed 33315158Siccoli A, Schroder ML, Staartjes VE. Association of age with incidence and timing of recurrence after microdiscectomy for lumbar disc herniation. Eur Spine J. 2021 Apr;30(4):893-898. doi: 10.1007/s00586-020-06692-1. Epub 2020 Dec 14.
- Background: PubMed 24139459Bilton K, Hammer L, Zaslawski C. Contemporary Chinese pulse diagnosis: a modern interpretation of an ancient and traditional method. J Acupunct Meridian Stud. 2013 Oct;6(5):227-33. doi: 10.1016/j.jams.2013.04.002. Epub 2013 Apr 24.
- Background: PubMed 33412329Shimony N, Louie C, Barrow D, Osburn B, Noureldine MHA, Tuite GF, Carey CM, Jallo GI, Rodriguez L. Adolescent Disc Disease: Risk Factors and Treatment Success-Related Factors. World Neurosurg. 2021 Apr;148:e314-e320. doi: 10.1016/j.wneu.2020.12.126. Epub 2021 Jan 4.
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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.
Lucheng Song, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
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 13 inclusion and 21 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 2 May 2022. 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 China. 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. 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 Lucheng Song, Doctor (+8613589089003, lucheng.s@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of abnormal sound waves in the pulses. (time frame: The data will be collected, analyzed and calculated in about 7 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859712, which also lists 5 linked publications.
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 2 May 2022.