Lumbar Disc HerniationCRPNCT07754422
Bladder Meridian Gua Sha for Lumbar Disc Herniation: Efficacy and CRP Regulation Via Cutaneous-Meridian-Visceral Axis in Shen Period
A study testing Observation group（standard treatment supplemented with Gua Sha） in people with Lumbar Disc Herniation, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
Based on the "Cutaneous Region-Meridian-Visceral" axis theory, in this study, we investigated clinical efficacy of the Gua Sha intervention on the Bladder Meridian during the Shen Period (3:00-5:00 p.m.) for lumbar disc herniation (LDH) and its regulatory effect on serum C-reactive protein (CRP).This randomized… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Observation group（standard treatment supplemented with Gua Sha）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2023to 30 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting the diagnostic criteria for LDH according to Traditional Chinese Medicine and Western Medicine
- Stable vital signs and absence of severe complications, including concomitant severe cardiovascular, cerebrovascular, hepatic, renal, or hematological diseases
- Patients able to cooperate with the entire course of treatment and sign an informed consent form
- Patients unsuitable for surgery and experiencing recurrent episodes following treatment
Who cannot join
- Participants unable to continue treatment
- Participants developing other serious illnesses during the trial
- Participants whose symptoms worsen to the point that emergency measures are required
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Foshan, GuanDongSheng, 528200
About this study
Official title: A Randomized Controlled Trial to Evaluate the Clinical Efficacy and C-Reactive Protein (CRP) Regulatory Mechanism of Bladder Meridian Gua Sha Therapy，Administered During the Shen Period, in Patients With Lumbar Disc Herniation, Based on the "Cutaneous Region-Meridian-Visceral" Axis Theory
Based on the "Cutaneous Region-Meridian-Visceral" axis theory, in this study, we investigated clinical efficacy of the Gua Sha intervention on the Bladder Meridian during the Shen Period (3:00-5:00 p.m.) for lumbar disc herniation (LDH) and its regulatory effect on serum C-reactive protein (CRP).This randomized controlled study enrolled 128patients with LDH admitted to the Department of Rehabilitation at Guangdong Hospital of Integrated Traditional Chinese and Western Medicine between January 2023 and December 2024. They were randomly assigned to a control group (n=64) and an observation group (n=64). The control group consisted of standard treatment and care according to the diagnostic and treatment guidelines for LDH. The observation group consisted of standard treatment and care supplemented with Gua Sha on the Bladder Meridian during the Shen Period. The Japanese Orthopedic Association (JOA) scores, Visual Analog Scale (VAS) pain scores, changes in CRP levels, and traditional Chinese medicine (TCM) efficacy evaluations were assessed for both groups before the intervention and at 2-week and 4-week after the intervention.
Read the detailed description
The control group will receive standard treatment and care including: (1) clinical observation - for patients in the acute phase, monitoring changes in the location and nature of pain, and use of a lumbar support belt when getting out of bed; (2) avoidance of raw, cold, and chilled foods during medication, with medication administered as prescribed; (3) maintenance of a nutritious diet, and avoidance of alcohol, raw, cold, and spicy foods; (4) monitoring of the patient's emotional state.
The observation group will receive the same standard treatment and care plus Gua Sha therapy administered along the Bladder Meridian during the Shen Period (3:00-5:00 p.m.) as follows:
- The patient assumes a seated position. The Gua Sha board is held at 45° to the skin in the direction of the meridian. After applying Gua Sha oil to the treatment area, a Hu Fu copper Gua Sha board (manufactured by Shanghai Wensha Tang, made of pure brass) is used.
- The fast-scraping technique is used to stimulate the following four acupoints: Da Zhui (GV14), Da Zhu (BL11), Gao Huang (BL43), and Shen Tang (BL44) for approximately 5 minutes.
- An alternating fast-slow scraping technique is used, focusing primarily on the Bladder Meridian while avoiding the face. First, scraping is performed from top to bottom along both sides of the spine, covering Tian Zhu (BL10), Da Zhu (BL11), and Feng Men (BL12). Then, scraping proceeds as follows: Step 1: Scraping the Back-Shu points corresponding to the viscera - Lung-Shu (BL13), Heart-Shu (BL15), Liver-Shu (BL18), Gallbladder-Shu (BL19), Spleen-Shu (BL20), Stomach-Shu (BL21), Sanjiao-Shu (BL22), Kidney-Shu (BL23), Qihai-Shu (BL24), Large Intestine-Shu (BL25), Guanyuan-Shu (BL26), Small Intestine-Shu (BL27), and Bladder-Shu (BL28) - to stimulate qi flow and regulate internal organ functions. Step 2: Scraping the acupoints in the sacral region, including Shangliao (BL31), Ciliao (BL32), Zhongliao (BL33), and Xialiao (BL34), to promote local blood circulation. Step 3: Along the posterior aspect of the lower limb, scraping from Chengfu (BL36) on the buttocks through Yinmen (BL37) to Weizhong (BL40) at the knee, then down the calf from Heyang (BL55) through Chengshan (BL57) and Feiyang (BL58), continuing to the ankle joint through Fuyang (BL59), Kunlun (BL60), and Pucan (BL61), and further to the lateral foot acupoints - Shenmai (BL62), Shugu (BL65), and Zutonggu (BL66) - finally ending at Zhiyin (BL67) at the tip of the little toe. This entire process includes 58 acupoints and takes approximately 35 minutes.
- After this, scraping is focused on Weizhong (BL40), Chengshan (BL57), Pucan (BL61), and Shenmai (BL62) for about 5 minutes.
- The scraping procedure starts from the upper body (trunk) and moves down to the lower limbs in the direction of muscle fibers until petechiae appear. Pressure is applied according to the patient's tolerance. Scraping is performed twice weekly, with an interval of 3-4 days between sessions, and alternated between the left and right Bladder Meridians. The treatment course lasts 4 weeks. If the patient is discharged, they are asked to return to the hospital at the scheduled time for scraping and to undergo monitoring of relevant indicators.
- Precautions: ① Scraping is performed in the direction of the meridians; ② The patient is kept warm and protected from wind and cold after scraping; ③ Even pressure is applied and adjusted to the patient's tolerance; ④ Scraping is avoided within 1 hour after a meal; ⑤ Areas with broken skin are avoided.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Control group（standard treatment and care）, Observation group（standard treatment supplemented with Gua Sha）
- Keywords
- Lumbar disc herniation, Gua Sha, "Cutaneous Region-Meridian-Visceral" Axis Theory, Bladder Meridian, Shen Period, Randomized Controlled Trial
- 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.
Control group（standard treatment and care）Other
Patients received the following standard treatment and care in accordance with the Diagnostic and Treatment Guidelines for LDH: (1) Clinical observation: For patients in the acute phase, changes was monitored in the location and nature of pain, and a lumbar support belt was used to stabilize the lower back when getting out of bed; (2) During medication, raw, cold, and chilled foods were avoided, and medication was administered as prescribed; (3) A nutritious diet was maintained; alcohol, raw, cold, and spicy foods were avoided; (4) Changes in the patient's emotional state were monitored.
Observation group（standard treatment supplemented with Gua Sha）Other
Gua Sha therapy was given along the Bladder Meridian during the Shen period (3:00-5:00 p.m.). The patient sat; a brass Hu Fu copper board (Shanghai Wensha Tang) was held at 45° along the meridian after applying oil. Fast scraping for 5 min on GV14, BL11, BL43, BL44; then alternating fast-slow on the meridian, avoiding face. First, scrape top-down along spine: BL10, BL11, BL12. Then back-shu points: BL13, BL15, BL18, BL19, BL20, BL21, BL22, BL23, BL24, BL25, BL26, BL27, BL28. Then sacral points BL31-BL34. Then lower limb posterior: from BL36 through BL37 to BL40, then down calf via BL55, BL57, BL58 to ankle, passing BL59, BL60, BL61, then lateral foot BL62, BL65, BL66, ending at BL67. Total 58 points for 35 min. Afterwards, focus on BL40, BL57, BL61, BL62 for 5 min. Scraping proceeds from upper trunk to lower limbs, along muscle fibres until petechiae appear; pressure according to tolerance. Twice weekly, 3-4 days apart, alternating left/right meridians, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group consisted of standard treatment and care according to the diagnostic and treatment guidelines for Lumbar Disc Herniation（LDH）. Receives: Other: Control group（standard treatment and care） |
| Observation Group | Experimental | The observation group consisted of standard treatment and care with Gua Sha on the Bladder Meridian during the Shen Period. Receives: Other: Observation group（standard treatment supplemented with Gua Sha） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Japanese Orthopedic Association (JOA) Score
The JOA score ranges from 0 to 29 points. Nine points are allocated to subjective symptoms (3 points for low back pain, 3 points for leg pain or numbness, and 3 points for walking ability), 6 points for objective signs (2 points each for the SLR test, motor deficits, and sensory deficits), and 14 points for limitations in daily living activities. A higher score indicates better lumbar spine function, whereas a lower score indicates poorer function.
Measured: * "Baseline" * "The second week after intervention" * ''The fourth week after intervention''
Secondary outcomes (1)
CRP Sample Collection and Testing
Serum sample was prepared by drawing 3 mL of fasting venous blood into a dry test tube, followed by centrifugation. The specific enzyme-linked immunosorbent assay was used to measure CRP levels according to the manufacturer's instructions.
Measured: * ''Baseline'' * ''The fourth week after intervention''
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start17 Jan 2023
- Primary completion19 Dec 2024
- Study completion30 Dec 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 128
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shu Mei, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754422
- Sponsor's protocol ID
- 2220001004583
- Acronym
- CRP
- Status last verified
- Jan 2023
- First submitted
- 21 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Clinical Efficacy and C-Reactive Protein (CRP) Regulatory Mechanism of Bladder Meridian Gua Sha Therapy，Administered During the Shen Period, in Patients With Lumbar Disc Herniation, Based on the "Cutaneous Region-Meridian-Visceral" Axis Theory
- ClinicalTrials.gov ID
- NCT07754422
- Acronym / sponsor ID
- CRP / 2220001004583
- Conditions
- Lumbar Disc Herniation
- Keywords
- Lumbar disc herniation, Gua Sha, "Cutaneous Region-Meridian-Visceral" Axis Theory, Bladder Meridian, Shen Period, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 10 Aug 2026 (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.
Based on the "Cutaneous Region-Meridian-Visceral" axis theory, in this study, we investigated clinical efficacy of the Gua Sha intervention on the Bladder Meridian during the Shen Period (3:00-5:00 p.m.) for lumbar disc herniation (LDH) and its regulatory effect on serum C-reactive protein (CRP).This randomized controlled study enrolled 128patients with LDH admitted to the Department of Rehabilitation at Guangdong Hospital of Integrated Traditional Chinese and Western Medicine between January 2023 and December 2024. They were randomly assigned to a control group (n=64) and an observation group (n=64). The control group consisted of standard treatment and care according to the diagnostic and treatment guidelines for LDH. The observation group consisted of standard treatment and care supplemented with Gua Sha on the Bladder Meridian during the Shen Period. The Japanese Orthopedic Association (JOA) scores, Visual Analog Scale (VAS) pain scores, changes in CRP levels, and traditional Chinese medicine (TCM) efficacy evaluations were assessed for both groups before the intervention and at 2-week and 4-week after the intervention.
Detailed description
The control group will receive standard treatment and care including: (1) clinical observation - for patients in the acute phase, monitoring changes in the location and nature of pain, and use of a lumbar support belt when getting out of bed; (2) avoidance of raw, cold, and chilled foods during medication, with medication administered as prescribed; (3) maintenance of a nutritious diet, and avoidance of alcohol, raw, cold, and spicy foods; (4) monitoring of the patient's emotional state.
The observation group will receive the same standard treatment and care plus Gua Sha therapy administered along the Bladder Meridian during the Shen Period (3:00-5:00 p.m.) as follows:
- The patient assumes a seated position. The Gua Sha board is held at 45° to the skin in the direction of the meridian. After applying Gua Sha oil to the treatment area, a Hu Fu copper Gua Sha board (manufactured by Shanghai Wensha Tang, made of pure brass) is used.
- The fast-scraping technique is used to stimulate the following four acupoints: Da Zhui (GV14), Da Zhu (BL11), Gao Huang (BL43), and Shen Tang (BL44) for approximately 5 minutes.
- An alternating fast-slow scraping technique is used, focusing primarily on the Bladder Meridian while avoiding the face. First, scraping is performed from top to bottom along both sides of the spine, covering Tian Zhu (BL10), Da Zhu (BL11), and Feng Men (BL12). Then, scraping proceeds as follows: Step 1: Scraping the Back-Shu points corresponding to the viscera - Lung-Shu (BL13), Heart-Shu (BL15), Liver-Shu (BL18), Gallbladder-Shu (BL19), Spleen-Shu (BL20), Stomach-Shu (BL21), Sanjiao-Shu (BL22), Kidney-Shu (BL23), Qihai-Shu (BL24), Large Intestine-Shu (BL25), Guanyuan-Shu (BL26), Small Intestine-Shu (BL27), and Bladder-Shu (BL28) - to stimulate qi flow and regulate internal organ functions. Step 2: Scraping the acupoints in the sacral region, including Shangliao (BL31), Ciliao (BL32), Zhongliao (BL33), and Xialiao (BL34), to promote local blood circulation. Step 3: Along the posterior aspect of the lower limb, scraping from Chengfu (BL36) on the buttocks through Yinmen (BL37) to Weizhong (BL40) at the knee, then down the calf from Heyang (BL55) through Chengshan (BL57) and Feiyang (BL58), continuing to the ankle joint through Fuyang (BL59), Kunlun (BL60), and Pucan (BL61), and further to the lateral foot acupoints - Shenmai (BL62), Shugu (BL65), and Zutonggu (BL66) - finally ending at Zhiyin (BL67) at the tip of the little toe. This entire process includes 58 acupoints and takes approximately 35 minutes.
- After this, scraping is focused on Weizhong (BL40), Chengshan (BL57), Pucan (BL61), and Shenmai (BL62) for about 5 minutes.
- The scraping procedure starts from the upper body (trunk) and moves down to the lower limbs in the direction of muscle fibers until petechiae appear. Pressure is applied according to the patient's tolerance. Scraping is performed twice weekly, with an interval of 3-4 days between sessions, and alternated between the left and right Bladder Meridians. The treatment course lasts 4 weeks. If the patient is discharged, they are asked to return to the hospital at the scheduled time for scraping and to undergo monitoring of relevant indicators.
- Precautions: ① Scraping is performed in the direction of the meridians; ② The patient is kept warm and protected from wind and cold after scraping; ③ Even pressure is applied and adjusted to the patient's tolerance; ④ Scraping is avoided within 1 hour after a meal; ⑤ Areas with broken skin are avoided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 128
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control group（standard treatment and care）The control group consisted of standard treatment and care according to the diagnostic and treatment guidelines for Lumbar Disc Herniation（LDH）. |
| Observation Group | Experimental | Other: Observation group（standard treatment supplemented with Gua Sha）The observation group consisted of standard treatment and care with Gua Sha on the Bladder Meridian during the Shen Period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients meeting the diagnostic criteria for LDH according to Traditional Chinese Medicine and Western Medicine
- Stable vital signs and absence of severe complications, including concomitant severe cardiovascular, cerebrovascular, hepatic, renal, or hematological diseases
- Patients able to cooperate with the entire course of treatment and sign an informed consent form
- Patients unsuitable for surgery and experiencing recurrent episodes following treatment
Key exclusion criteria (3 listed)
- Participants unable to continue treatment
- Participants developing other serious illnesses during the trial
- Participants whose symptoms worsen to the point that emergency measures are required
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 |
|---|---|---|
| Control group（standard treatment and care）Patients received the following standard treatment and care in accordance with the Diagnostic and Treatment Guidelines for LDH: (1) Clinical observation: For patients in the acute phase, changes was monitored in the location and nature of pain, and a lumbar support belt was used to stabilize the lower back when getting out of bed; (2) During medication, raw, cold, and chilled foods were avoided, and medication was administered as prescribed; (3) A nutritious diet was maintained; alcohol, raw, cold, and spicy foods were avoided; (4) Changes in the patient's emotional state were monitored. | Other | Control Group |
| Observation group（standard treatment supplemented with Gua Sha）Gua Sha therapy was given along the Bladder Meridian during the Shen period (3:00-5:00 p.m.). The patient sat; a brass Hu Fu copper board (Shanghai Wensha Tang) was held at 45° along the meridian after applying oil. Fast scraping for 5 min on GV14, BL11, BL43, BL44; then alternating fast-slow on the meridian, avoiding face. First, scrape top-down along spine: BL10, BL11, BL12. Then back-shu points: BL13, BL15, BL18, BL19, BL20, BL21, BL22, BL23, BL24, BL25, BL26, BL27, BL28. Then sacral points BL31-BL34. Then lower limb posterior: from BL36 through BL37 to BL40, then down calf via BL55, BL57, BL58 to ankle, passing BL59, BL60, BL61, then lateral foot BL62, BL65, BL66, ending at BL67. Total 58 points for 35 min. Afterwards, focus on BL40, BL57, BL61, BL62 for 5 min. Scraping proceeds from upper trunk to lower limbs, along muscle fibres until petechiae appear; pressure according to tolerance. Twice weekly, 3-4 days apart, alternating left/right meridians, for 4 weeks. | Other | Observation Group |
Primary outcome
Japanese Orthopedic Association (JOA) Score
Time frame: * "Baseline" * "The second week after intervention" * ''The fourth week after intervention''
The JOA score ranges from 0 to 29 points. Nine points are allocated to subjective symptoms (3 points for low back pain, 3 points for leg pain or numbness, and 3 points for walking ability), 6 points for objective signs (2 points each for the SLR test, motor deficits, and sensory deficits), and 14 points for limitations in daily living activities. A higher score indicates better lumbar spine function, whereas a lower score indicates poorer function.
1 secondary outcome
CRP Sample Collection and Testing
Time frame: * ''Baseline'' * ''The fourth week after intervention''
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 10 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation group（standard treatment supplemented with Gua Sha） in people with Lumbar Disc Herniation, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 4 inclusion and 3 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 10 Aug 2026. 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?
Japanese Orthopedic Association (JOA) Score (time frame: * "Baseline" * "The second week after intervention" * ''The fourth week after intervention''). 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 10 Aug 2026.