Lumbar Disc HerniationNCT06318156
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
A study testing Infrared thermal imaging in people with Lumbar Disc Herniation, run by Zhou Xingchen at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Infrared thermal imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053
About this study
Official title: 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.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Infrared thermal imaging
- Keywords
- Lumbar Disc Herniation, Press quickly, Point-press method, Pressure-sensitive acupoints, Infrared thermal imaging
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared thermal imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Infrared thermal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhou Xingchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Xingchen, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Li-Jiang Lv, Ph.D., Study chair, The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318156
- Sponsor's protocol ID
- ZSLL-KY-2024-056-03
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06318156
- Acronym / sponsor ID
- ZSLL-KY-2024-056-03
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar Disc Herniation, Press quickly, Point-press method, Pressure-sensitive acupoints, Infrared thermal imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Zhou XingchenUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1(lumbar disc herniation) | Experimental | Diagnostic Test: Infrared thermal imagingA 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. |
| Group2 (healthy control) | Experimental | Diagnostic Test: Infrared thermal imagingA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared thermal imagingA 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 | Group1(lumbar disc herniation), Group2 (healthy control) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Jiang Lv, Ph.D. study chair
The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared thermal imaging in people with Lumbar Disc Herniation, run by Zhou Xingchen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin temperature (time frame: up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.