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Completed

NCT Number: NCT07754422

Bladder Meridian Gua Sha for Lumbar Disc Herniation: Efficacy and CRP Regulation Via Cutaneous-Meridian-Visceral Axis in Shen Period

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

Foshan, GuanDongSheng, 528200, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. CRP Sample Collection and Testing

    Time frame: * ''Baseline'' * ''The fourth week after intervention''

    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.

Other outcomes

  1. Visual Analog Scale (VAS) Pain Score

    Time frame: * ''Baseline'' * ''The second week after intervention'' * ''The fourth week after intervention''

    The severity of pain was scored on a scale of 0-10 points. A score of 0 indicates no pain and a score of 10 indicates highest degree of pain.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Other

Registry information

Official study 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

Acronym: CRP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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