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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Japanese Orthopedic Association (JOA) Score
Study Overview
Brief 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Randomization and Blinding This study used the random number table method for simple randomization and generated an allocation sequence for enrolled participants in a 1:1 ratio. The allocation sequence was preloaded into sequentially numbered, opaque, and sealed envelopes. The envelope corresponding to each participant's number was then opened to determine their unique group assignment. Due to significant differences in treatment regimens between groups, it was difficult to maintain patient blinding. However, the follow-up scoring process used standardized codes to ensure objective and reliable data evaluation. During the efficacy assessment phase, all evaluators were unaware of the patient group assignments and used only codes to identify patients during the assessment process to avoid assessment bias.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
The control group consisted of standard treatment and care according to the diagnostic and treatment guidelines for Lumbar Disc Herniation（LDH）.
Intervention: Control group（standard treatment and care） (Other)
Observation Group
The observation group consisted of standard treatment and care with Gua Sha on the Bladder Meridian during the Shen Period.
Intervention: Observation group（standard treatment supplemented with Gua Sha） (Other)
Outcomes
Primary Outcomes
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
- CRP Sample Collection and Testing(* ''Baseline'' * ''The fourth week after intervention'')
Investigators
Li Shu Mei
Chief Nurse, Guangdong Hospital of Integrated Traditional Chinese and Western Medicine.
Guangdong Provincial Hospital of Traditional Chinese Medicine