NCT06318156

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

March 13, 2024

Last Update Submit

June 13, 2025

Conditions

Keywords

Lumbar Disc HerniationPress quicklyPoint-press methodPressure-sensitive acupointsInfrared thermal imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group1(lumbar disc herniation)

EXPERIMENTAL

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

Group2 (healthy control)

EXPERIMENTAL

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

Interventions

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.

Group1(lumbar disc herniation)Group2 (healthy control)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Li-Jiang Lv, Ph.D.

    The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang,China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 19, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations