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

NCT07754422 | Completed DMC

• 1 other identifier: 2220001004583
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Keywords

Lumbar disc herniation; Gua Sha; "Cutaneous Region-Meridian-Visceral" Axis Theory; Bladder Meridian; Shen Period; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  * "Baseline" * "The second week after intervention" * ''The fourth week after intervention''

Secondary Outcomes (1)

• CRP Sample Collection and Testing

  * ''Baseline'' * ''The fourth week after intervention''

Other Outcomes (1)

• Visual Analog Scale (VAS) Pain Score

  * ''Baseline'' * ''The second week after intervention'' * ''The fourth week after intervention''

Study Arms (2)

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）.

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.

Other: Observation group（standard treatment supplemented with Gua Sha）

Interventions

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.

Control Group

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.

Observation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine

Foshan, GuanDongSheng, 528200, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse, Guangdong Hospital of Integrated Traditional Chinese and Western Medicine.

Model Details: 128

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 10, 2026
• Study Start: January 17, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 30, 2024
• Last Updated: August 10, 2026

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)