Exploring the Distribution Patterns and Infrared Characteristics of Force-sensitive Acupoints in Different Lumbar Nerve Segments in Patients With LDH Based on "Press Quickly" Theory

March 13, 2024 updated by: Zhou Xingchen

Exploring the Distribution Patterns and Infrared Characteristics of Force-sensitive Acupoints in Different Lumbar Nerve Segments in Patients With Lumbar Disc Herniation Based on "Press Quickly" Theory

Utilizing the "responsive acupoint palpation" technique and infrared thermography, we investigated the distribution patterns of pressure-sensitive acupoints across different lumbar spinal segments in patients with lumbar disc herniation (LDH). Methodology: The Finger TPS tactile pressure measurement system was employed to conduct sensitivity examinations on the acupoints of the L1~L5 lumbar spine in 80 LDH patients (Group 1) and 80 healthy individuals (Group 2), applying a standardized force of 60N. When a sensation of comfort was elicited, the points were marked on a human cutaneous nerve segment map. We then utilized infrared thermography to collect and compare the temperature differences of the top 10 most frequently responsive acupoint areas in the experimental group against those in the control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310053
        • Recruiting
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age range of 18 to 65 years, regardless of gender.
  • Radiological confirmation of central type L4~L5 intervertebral disc herniation.
  • Meeting the diagnostic criteria for lumbar disc herniation, primarily manifesting as lower back pain, radicular pain, and numbness or weakness in the lower limbs, with imaging findings consistent with neurological localization.
  • Patients in the non-acute phase of mild to moderate pain and functional impairment (onset more than 2 weeks ago), with a visual analog scale (VAS) score greater than 4 points and a Japanese Orthopaedic Association (JOA) score less than 15 points.
  • No consumption of analgesics, neurotrophic drugs, or sedatives, and no systemic treatment in the past week.
  • Willing participants in the study who have signed an informed consent form.

Exclusion Criteria:

  • Concomitant internist and gynecological diseases that can cause lower back pain, such as nephritis, urinary tract stones, gynecological inflammations, and uterine pathologies.
  • Individuals with severe primary diseases of the cardiovascular, cerebrovascular, liver, kidney, etc.
  • Patients with neurosis or psychiatric disorders, or those with a history of cranial trauma or coma.
  • Patients with primary or ankylosing sciatica.
  • Individuals with concomitant lumbar spondylolisthesis.
  • Patients with lumbar spine tumors or tuberculosis.
  • Individuals with consciousness disorders, severe impairments in vision, hearing, or speech, or any other condition that prevents the completion of a health assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1(lumbar disc herniation)
A well-trained physician donned the Finger TPS tactile pressure measurement system (Finger TPS II, BTLETG03, USA), methodically applying a consistent 60N force with a single thumb vertically downward on the acupoints of the L1 to L5 spinal segments, in accordance with the human cutaneous nerve segment map. Additionally, environmental conditions were meticulously controlled-temperature maintained between 20°C to 25°C, relative humidity at 50% to 60%, with gentle indoor lighting, quiet, and stable airflow. The MESH T-1000 Smart medical infrared thermograph, produced by Wuhan Gewu Optoelectronics Technology Co., Ltd., was utilized to assess the surface temperature of the patient's pressure-sensitive acupoint areas.
Diagnostic test: Infrared thermal imaging
A well-trained physician donned the Finger TPS tactile pressure measurement system (Finger TPS II, BTLETG03, USA), methodically applying a consistent 60N force with a single thumb vertically downward on the acupoints of the L1 to L5 spinal segments, in accordance with the human cutaneous nerve segment map. Additionally, environmental conditions were meticulously controlled-temperature maintained between 20°C to 25°C, relative humidity at 50% to 60%, with gentle indoor lighting, quiet, and stable airflow. The MESH T-1000 Smart medical infrared thermograph, produced by Wuhan Gewu Optoelectronics Technology Co., Ltd., was utilized to assess the surface temperature of the patient's pressure-sensitive acupoint areas.
Experimental: Group2 (healthy control)
A well-trained physician donned the Finger TPS tactile pressure measurement system (Finger TPS II, BTLETG03, USA), methodically applying a consistent 60N force with a single thumb vertically downward on the acupoints of the L1 to L5 spinal segments, in accordance with the human cutaneous nerve segment map. Additionally, environmental conditions were meticulously controlled-temperature maintained between 20°C to 25°C, relative humidity at 50% to 60%, with gentle indoor lighting, quiet, and stable airflow. The MESH T-1000 Smart medical infrared thermograph, produced by Wuhan Gewu Optoelectronics Technology Co., Ltd., was utilized to assess the surface temperature of the patient's pressure-sensitive acupoint areas.
Diagnostic test: Infrared thermal imaging
A well-trained physician donned the Finger TPS tactile pressure measurement system (Finger TPS II, BTLETG03, USA), methodically applying a consistent 60N force with a single thumb vertically downward on the acupoints of the L1 to L5 spinal segments, in accordance with the human cutaneous nerve segment map. Additionally, environmental conditions were meticulously controlled-temperature maintained between 20°C to 25°C, relative humidity at 50% to 60%, with gentle indoor lighting, quiet, and stable airflow. The MESH T-1000 Smart medical infrared thermograph, produced by Wuhan Gewu Optoelectronics Technology Co., Ltd., was utilized to assess the surface temperature of the patient's pressure-sensitive acupoint areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin temperature
Time Frame: up to one month
The medical infrared thermographic camera captures thermal images of the human cutaneous nerve segment map on the back of the subjects, focusing on the L1 to L5 spinal segment areas.
up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhou Xingchen

Investigators

  • Study Chair: Li-Jiang Lv, Ph.D., The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang,China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSLL-KY-2024-056-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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