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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318156
Other study ID # ZSLL-KY-2024-056-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date January 1, 2025

Study information

Verified date March 2024
Source The Third Affiliated hospital of Zhejiang Chinese Medical University
Contact Xing-chen Zhou, Ph.D.
Phone +86-18370133761
Email zhouxingchen0210@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
China The Third Affiliated Hospital of Zhejiang Chinese Medical University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhou Xingchen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary skin temperature 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
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