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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 1 month. |
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Inclusion Criteria:
- Trial group
control group
Exclusion Criteria:
- Trial group
control group
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Patients with lumbar disc herniation and relatively healthy people
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucheng Song, Doctor | Contact | +8613589089003 | lucheng.s@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lucheng Song, Doctor | The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University | Recruiting | Jinan | Shandong | 250014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33667683 | Background | 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. | |
| 33315945 | Background | Ishitani 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 14, 2022 | |
| Reset | Mar 29, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2021 | Apr 24, 2022 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 14, 2022 | Mar 29, 2023 |
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| 33315158 | Background | Siccoli 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. |
| 24139459 | Background | Bilton 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. |
| 33412329 | Background | Shimony 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |