A Diagnostic Test of Abnormal Sound Waves in Modern Pulsology of Lumbar Disc Herniation

NCT04859712 | Unknown

• 1 other identifier: SFUYIN-03
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lumbar Disc Herniation; Radial Artery

Keywords

Diagnostic Test; Lumbar Disc Herniation; Radial Artery

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with lumbar disc herniation and relatively healthy people

You may qualify if:

• \- 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;
• 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;

You may not qualify if:

• \- 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;
• 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;

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 33667683 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.

  PMID: 33315945 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.

  PMID: 33315158 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.

  PMID: 24139459 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.

  PMID: 33412329 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucheng Song, Doctor

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucheng Song, Doctor

CONTACT

+8613589089003; lucheng.s@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: April 26, 2021
• Study Start: April 9, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CN (1)