A Standardized Copper Bian-Stone Gua Sha Protocol for Treating Chronic Fatigue Syndrome in Human Subjects

Summary

This protocol describes a standardized, step-by-step procedure for performing copper Bian-stone Gua Sha in human subjects diagnosed with chronic fatigue syndrome. The technique involves the application of a copper alloy scraper to specific meridian pathways (Governor Vessel and Bladder Meridian) and designated acupoints. Representative pre- and post-intervention observational data are included to illustrate the procedural workflow and data collection methods.

Abstract

Chronic fatigue syndrome (CFS) is characterized by persistent, unexplained fatigue lasting six months or longer. This protocol describes a standardized copper Bian-stone Gua Sha procedure for application in human subjects with CFS. The procedure targets the Governor Vessel (from Dazhui DU14 to Yaoyangguan DU3) and the Bladder Meridian (from Feishu BL13 to Shenshu BL23). A copper Bian-stone scraper is used to apply light scraping along the meridians at approximately 5 cm/s, with moderate pressure applied for 30 s at Back-Shu points (Pishu BL20, Weishu BL21, Shenshu BL23). Scraping continues until uniform petechiae (sha) appear or 10 strokes per segment are completed. Sessions last approximately 20 min and are performed twice weekly for two weeks. Pre- and post-intervention assessments include the Fatigue Severity Scale (FSS), a TCM syndrome score, and the SF-36 Health Survey. Representative changes in these scores are documented to illustrate protocol execution. This protocol emphasizes standardized acupoint localization, pressure calibration, and safety monitoring to facilitate reproducibility in clinical research settings.

Introduction

Chronic fatigue syndrome (CFS) is a clinical condition characterized by persistent or recurrent fatigue lasting six months or longer that is not substantially alleviated by rest and cannot be explained by an underlying medical condition¹. The global prevalence of CFS has been reported to be increasing, and prolonged fatigue may contribute to functional impairment across multiple physiological systems².

Current pharmacological interventions for CFS are primarily symptomatic and include anti-fatigue agents and low-dose antidepressants; however, long-term use may be associated with adverse effects such as gastrointestinal discomfort and dependency³. As a result, non-pharmacological approaches, including certain Traditional Chinese Medicine (TCM) external therapies, have been explored as alternative or adjunctive options. Gua Sha is a TCM technique that involves instrument-assisted scraping of the skin along designated meridian pathways. The use of copper Bian-stone scrapers introduces specific material properties, such as thermal conductivity, that differ from traditional tools made of horn or jade.

This protocol describes a standardized copper Bian-stone Gua Sha procedure for application in human subjects with CFS. The aim is to provide a detailed, step-by-step framework covering material preparation, acupoint localization, scraping technique, pressure calibration, and safety monitoring. The protocol emphasizes reproducibility and is intended for use in clinical research settings where a consistent, well-documented external intervention is required.

(Note: This study focused on the relationship between syndrome homogeneity and therapeutic efficacy; the age and gender distribution of individual patients were not systematically recorded or analyzed. All efficacy was based on the entire enrolled population = 20.)

Protocol

This study has been approved by the Ethics Committee of the Fifth Clinical Medical College of Guangzhou University of Chinese Medicine / the Second Traditional Chinese Medicine Hospital of Guangdong(Number: 202511-004-02). Informed consent was obtained from all participants all experimental procedures strictly adhered to the Declaration of Helsinki and institutional ethical standards for human research.

1. Diagnostic criteria

1. Define chronic fatigue syndrome as a clinical syndrome characterized by persistent fatigue as the primary manifestation, absence of a clear disease diagnosis explaining the fatigue, lack of relief after rest, and recurrence or persistence for more than 6 months.
2. Use the Western medical diagnostic criteria for chronic fatigue syndrome outlined in Reference ¹.
3. Confirm persistent or recurrent fatigue lasting 6 months or longer, with no clear underlying cause and no adequate relief after rest.
4. Confirm the presence of at least four of the following symptoms:
   1. Identify impaired memory or difficulty concentrating.
   2. Identify sore or tender lymph nodes in the neck or armpits.
   3. Identify generalized muscle pain.
   4. Identify multi-joint pain.
   5. Identify unrefreshing sleep.
   6. Identify post-exertional malaise lasting more than 24 h.
5. Exclude other conditions that explain the current state of fatigue.
6. Establish the Traditional Chinese Medicine diagnosis according to the “Criteria for Diagnosis and Therapeutic Effect of TCM Diseases and Syndromes,” specifically the syndrome classification related to phlegm-dampness and blood stasis, in combination with expert opinion and clinical practice⁴.
7. Confirm the following primary symptoms:
   1. Confirm heaviness in the body.
   2. Confirm aching pain in the muscles and joints.
8. Confirm the following secondary symptoms:
   1. Confirm poor appetite.
   2. Confirm sticky stools.
   3. Confirm excessive vaginal discharge in women.
9. Examine the tongue coating and confirm thick, greasy, white or yellow coating.
10. Examine the sublingual collateral vessels and confirm tortuous vessels.
11. Assess the pulse for deep and choppy qualities or wiry and slippery qualities.
12. Treat the pulse finding as an auxiliary diagnostic criterion and exclude it from the syndrome score.
13. Diagnose the phlegm-dampness and blood stasis syndrome only when the patient presents with both primary symptoms and at least two secondary symptoms.

2. Inclusion criteria

1. Include participants aged 18–60 years.
2. Include eligible participants of any sex.
3. Include participants with a clinical diagnosis of chronic fatigue syndrome.
4. Include participants whose TCM diagnostic classification meets the phlegm-dampness and blood stasis obstruction type.
5. Confirm that the participant has received no treatment for at least 2 weeks before the intervention, including drug treatment and other Traditional Chinese Medicine treatments.
6. Enroll only participants who voluntarily participate in the research project.
7. Confirm that each participant communicates adequately with the researchers, cooperates actively, and signs the informed consent form.

3. Exclusion criteria

1. Exclude pregnant women.
2. Exclude lactating women.
3. Exclude patients with a history of emotional disorders or current emotional disorders.
4. Exclude patients with major concurrent diseases, including emphysema, heart failure, cirrhosis, or kidney failure.
5. Exclude patients whose chronic fatigue results from other diseases, including hypothyroidism, sleep disorders, or osteoarthritis.
6. Exclude patients with current or previous skin diseases that interfere with safe scraping.
7. Exclude patients with ulcerated skin in the planned treatment area.
8. Exclude patients with poor compliance.
9. Exclude participants with a history of alcohol abuse before developing chronic fatigue syndrome.
10. Exclude participants with a history of drug dependence before developing chronic fatigue syndrome.

4. Termination criteria

1. Terminate the trial for a participant when the researchers determine, from a medical perspective, that trial termination is necessary.
2. Stop the trial immediately when the participant requests withdrawal.
3. Terminate participation when the participant receives treatments outside the measures stipulated in this trial.
4. Document the reason for termination in the study record.

5. Preparation of materials, environment, and safety controls

1. Prepare the following materials: disposable medical examination gloves, copper Bian-stone scraper, Gua Sha oil, 75% medical alcohol, sterile cotton balls, and medical forceps (Figure 1A–F).
2. Refer to the Table of Materials for detailed specifications.
3. Inspect all packaging for integrity before use.
4. Check expiration dates before use.
5. Confirm sterilization of all instruments before use.
6. Maintain the treatment room at 24 °C ± 2 °C.
7. Maintain illumination at approximately 500 lux.
   Note: Adjust room temperature within 22–26 °C and illumination within 300–700 lux according to patient comfort and document the selected values.
8. Use a clean, well-ventilated clinical treatment room.
9. Keep 75% medical alcohol away from heat, open flames, sparks, electrocautery equipment, and other ignition sources.
10. Keep alcohol containers capped when not in use.
11. Apply 75% medical alcohol with sterile cotton balls.
12. Do not spray alcohol or generate aerosols during skin disinfection.
13. Use a chemical fume hood only for separate preparation or transfer of volatile or irritating chemicals when institutional safety policy requires hood use.
14. Do not place the patient inside a chemical fume hood or biosafety cabinet.
15. Do not perform the Gua Sha treatment inside a chemical fume hood or biosafety cabinet.
    Note: Routine hood use is not applicable to the patient treatment procedure because this protocol uses cotton-applied 75% medical alcohol and Gua Sha oil.
16. Don a clean work uniform before preparing the patient.
17. Perform hand hygiene according to standard medical handwashing protocols⁵.
18. Wear a fresh pair of disposable medical examination gloves.
19. Replace gloves immediately if they tear, become visibly contaminated, or contact non-clean surfaces.
20. Wear eye protection and a medical mask when splash exposure is possible.
21. Assign a licensed acupuncturist or licensed TCM practitioner trained in Gua Sha procedures and emergency management to perform the intervention.
22. Use the same operator for all sessions for a given patient to minimize inter-operator variability.
23. Dispose of used gloves, cotton balls, and contaminated disposable materials as clinical waste according to institutional infection-control procedures.
24. Clean and disinfect reusable instruments after each use according to institutional infection-control procedures.

6. Patient preparation

1. Explain the purpose of the procedure to the patient.
2. Explain expected sensations, including soreness and pressure.
3. Explain potential skin changes, including sha appearance.
4. Explain post-treatment precautions before the intervention begins.
5. Confirm that the patient is not excessively hungry.
6. Confirm that the patient is not excessively full.
7. Confirm that the patient is not excessively fatigued.
8. Confirm that the patient is not excessively stressed.
9. Schedule the procedure 1–2 h after a meal.
10. Inspect the posterior trunk before treatment.
11. Do not scrape areas with ulceration, infection, active dermatitis, open wounds, bleeding, severe bruising, or other unsafe skin findings.
12. Position the patient in a seated posture with an approximately 15° forward lean.
13. Place the patient’s arms on padded support.
14. Expose the posterior trunk region selected for scraping.
15. Drape all non-treated areas with a blanket to maintain warmth and privacy.

7. Selection of the scraping area

1. Determine acupoint locations according to the national standard of the People’s Republic of China, “Nomenclature and Location of Meridian Points⁶.”
2. Select the Governor Vessel from Dazhui (DU14) along the spinal midline down to Yaoyangguan (DU3) (Figure3).
3. Select the bilateral Bladder Meridian of Foot-Taiyang from Feishu (BL13) to Shenshu (BL23), including Pishu (BL20) and Weishu (BL21), located 1.5 cun lateral to the posterior midline.
   Note: Existing research reports therapeutic effects of the Governor Vessel and Bladder Meridian (Figure 4) for the syndrome type investigated in this study⁷.
4. Measure acupoint distances with the finger-cun measurement method.
5. Use the patient’s own fingers as the reference for measurement.
6. Use the middle crease of the patient’s middle finger as the benchmark.
7. Define the combined width of the patient’s index and middle fingers as 1.5 cun (Figure 2).
8. Locate Dazhui (DU14) in the depression below the spinous process of the 7th cervical vertebra on the posterior midline (Figure3).
9. Locate Yaoyangguan (DU3) in the depression below the spinous process of the 4th lumbar vertebra on the posterior midline (Figure3).
10. Locate Feishu (BL13) 1.5 cun lateral to the posterior midline, below the spinous process of the 3rd thoracic vertebra (Figure 4).
11. Locate Pishu (BL20) 1.5 cun lateral to the posterior midline, below the spinous process of the 11th thoracic vertebra (Figure 4).
12. Locate Weishu (BL21) 1.5 cun lateral to the posterior midline, below the spinous process of the 12th thoracic vertebra (Figure 4).
13. Locate Shenshu (BL23) 1.5 cun lateral to the posterior midline, below the spinous process of the 2nd lumbar vertebra (Figure 4).

8. Gua Sha treatment procedure

1. Position the patient in a seated posture with an approximately 15° forward lean.
2. Expose the back while maintaining warmth and privacy with appropriate draping.
3. Hold a sterile cotton ball with medical forceps.
4. Disinfect the skin from Dazhui (DU14) to Yaoyangguan (DU3) and along the bilateral Bladder Meridian lines with 75% medical alcohol.
5. Repeat the disinfection three times.
6. Allow the skin to air dry for 10 s between applications.
7. Apply approximately 5 mL of Gua Sha oil evenly over the target area.
8. Hold the sterilized copper Bian-stone scraper at a 45° angle to the skin surface.
9. Begin at Dazhui (DU14).
10. Apply the light scraping technique along the spinal midline toward Yaoyangguan (DU3) at approximately 5 cm/s.
    Note: Define the light scraping technique as pressure that produces skin indentation of less than 2 mm.
11. Repeat the downward scraping motion 10 times along the Governor Vessel.
12. Increase pressure briefly to the moderate-pressure scraping technique at Dazhui (DU14) for 30 s.
13. Increase pressure briefly to the moderate-pressure scraping technique at Yaoyangguan (DU3) for 30 s.
    Note: Define the moderate-pressure technique as pressure that produces skin indentation of 3–5 mm, equivalent to a force of 5–10 N.
14. Monitor patient discomfort continuously using a 0–10 Visual Analog Scale.
15. Do not exceed a patient-reported pain score of 4.
16. Reduce pressure immediately when the pain score exceeds 4.
17. Proceed to the bilateral Bladder Meridian lines.
18. Begin at Feishu (BL13).
19. Scrape downward from Feishu (BL13) to Shenshu (BL23).
20. Apply the light scraping technique along the meridian.
21. Switch to the moderate-pressure technique for 30 s at Pishu (BL20).
22. Switch to the moderate-pressure technique for 30 s at Weishu (BL21).
23. Switch to the moderate-pressure technique for 30 s at Shenshu (BL23).
24. Repeat the scraping sequence 10 times on each side of the spine.
25. Stop the procedure immediately if the patient experiences dizziness, palpitations, cold sweats, nausea, pallor, faintness, chest discomfort, shortness of breath, or any other concerning symptom.
26. Place the patient in a supine position when an adverse reaction occurs.
27. Assess airway, breathing, circulation, level of consciousness, and vital signs when an adverse reaction occurs.
28. Confirm that oral intake is safe before giving fluids
29. Administer 200 mL of warm water containing 10 g of glucose when the patient is conscious, able to swallow safely, and has no glucose-related contraindication.
30. Activate institutional emergency procedures when symptoms persist, worsen, or indicate a medical emergency.
31. Continue scraping until uniform petechiae, or sha, appear at a density of 10–15 petechiae per cm², or until 10 strokes per segment are completed, whichever endpoint occurs first.
32. Do not pursue excessive sha formation.
33. Discontinue scraping once the defined endpoint is reached.
34. Limit the total session duration to approximately 20 min.
35. Gently wipe residual oil from the skin with a soft cloth after completion.
36. Inspect the treated skin for excessive irritation, bleeding, blistering, or other abnormal findings.
37. Advise the patient to keep the scraped area warm.
38. Advise the patient to avoid wind exposure for 4–6 h.
39. Advise the patient to avoid cold-water exposure for 4–6 h.
40. Document the treatment sites, scraping duration, patient response, pain score, sha appearance, adverse events, and post-treatment instructions.

9. Adverse event management

1. Stop the procedure immediately when dizziness, cold sweats, palpitations, nausea, pallor, faintness, or other adverse symptoms occur.
2. Place the patient flat in a supine position.
3. Keep the patient warm.
4. Assess airway, breathing, circulation, consciousness, and vital signs.
5. Provide warm sugar water only after confirming that the patient is conscious, able to swallow safely, and has no contraindication to glucose intake.
6. Reduce scraping pressure immediately when intensified localized pain occurs.
7. Ask the patient to describe the location, intensity, and quality of pain.
8. Cease the procedure when pain worsens, persists, or indicates tissue injury.
9. Inspect the treated skin when localized pain intensifies.
10. Provide appropriate clinical care according to institutional procedures when skin injury, excessive bruising, bleeding, blistering, syncope, allergic reaction, or other adverse findings occur.
11. Report and document all adverse events in accordance with the study protocol and institutional requirements.

10. Efficacy observation

1. Administer the Fatigue Severity Scale as the primary outcome measure⁸.
2. Ask patients to rate fatigue over the past 1–2 weeks.
3. Present all 9 Fatigue Severity Scale items to the patient.
4. Instruct the patient to select one of 7 graded options for each item.
5. Assign 1 point to “does not affect at all.”
6. Assign 7 points to “severely affects.”
7. Increase scores sequentially by 1 point across the response options.
8. Sum the scores from all 9 items to obtain the total Fatigue Severity Scale score.
9. Interpret a higher Fatigue Severity Scale score as more severe fatigue.
10. Administer the TCM Syndrome Score as a secondary outcome measure⁹.
11. Quantify symptoms including bodily heaviness, joint soreness, tongue coating, and sublingual collateral vessel findings.
12. Score the 3 TCM Syndrome Score items according to the patient’s subjective symptoms and objective tongue and pulse signs.
13. Instruct the evaluator to select one of 4 graded options for each item.
14. Assign 0 points to the absence of the symptom, absence of greasy coating, or absence of tortuous sublingual collaterals.
15. Assign 3 points to severe symptoms, thick coating, or clustered black sublingual collaterals.
16. Increase scores by 1 point for each response option.
17. Interpret a higher TCM Syndrome Score as more pronounced phlegm-dampness and blood stasis syndrome.
18. Administer the SF-36 Health Survey as a secondary outcome measure^10,11.
19. Present all 36 SF-36 items to the patient.
20. Ask the patient to answer each item according to life status over the past 1–2 weeks.
21. Score all SF-36 items in a positive direction according to the survey manual.
22. Calculate the score for each of the 8 core domains according to the survey manual algorithm.
23. Interpret a higher SF-36 domain score as better health status in the corresponding domain.
24. Evaluate overall efficacy according to the efficacy criteria for chronic fatigue syndrome described in the reference¹².
25. Classify the outcome as clinical recovery when primary and secondary clinical symptoms disappear completely, the TCM syndrome score reaches 0, and the SF-36 score reaches the maximum.
    Note: Verify the intended Fatigue Severity Scale threshold for clinical recovery before final use, because the source text lists an FSS value of 0 while the scoring instructions define each FSS item as 1–7 points.
26. Classify the outcome as markedly effective when most primary and secondary clinical symptoms disappear and the Fatigue Severity Scale, TCM Syndrome Score, and SF-36 scores show marked improvement.
27. Classify the outcome as effective when a portion of primary and secondary clinical symptoms disappear and the Fatigue Severity Scale, TCM Syndrome Score, and SF-36 scores show partial improvement.
28. Classify the outcome as ineffective when primary and secondary clinical symptoms do not disappear and the Fatigue Severity Scale, TCM Syndrome Score, and SF-36 scores show no improvement.

11. Statistical analysis

1. Collect study data using standardized case report forms or the approved study database.
2. Perform statistical analysis using SPSS Statistics for Windows, Version 27.0.
3. Express continuous data as mean ± standard deviation.
4. Use a paired-samples t-test to compare pre-intervention and post-intervention values.
5. Treat a two-sided P value of <0.05 as indicating a statistically significant difference

Results

This study describes a copper Bian-gua-sha scraping treatment protocol for chronic fatigue syndrome with a Phlegm-Dampness and Blood Stasis pattern(Figure 5). A total of 20 patients who met the inclusion criteria were enrolled and completed the trial. All patients were diagnosed using uniform criteria the identical Gua Sha therapy protocol was performed by the same practitioner. Evaluations using the Fatigue Severity Scale SF-36 Health Survey the TCM Syndrome Score were conducted for all pat...

Discussion

The present protocol describes a standardized copper Bian-stone Gua Sha procedure for application in human subjects with chronic fatigue syndrome (CFS). In the execution of this protocol, changes in Fatigue Severity Scale (FSS) scores, TCM syndrome scores, and SF-36 domain scores were recorded between pre- and post-intervention time points in the 20-subject cohort. The observed differences are presented as representative data to illustrate the protocol's procedural flow and outcome documentation, rather than to estab...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Alcohol,75% medical grade	Guangdong Province Guangning County Shunning Glucose Pharmaceutical Co., Ltd.	N/A	CAS 64-17-5;thanol concentration 75% ± 1% (v/v); Medical disinfectant grade
Copper Bian-stone scraper	Liaoning Province Xiangsha Health Management Consulting Co., Ltd.	Model:H62(C28000)	H62 brass alloy (copper content ≥ 61.2035%); Dimensions: 180 mm × 40 mm × 4 mm; Weight: 160 ± 5 g; Edge radius: 2 mm; Surface treatment: polished
Cotton balls,sterile	Guangzhou Haozheng Medical Devices Co., Ltd.	N/A	Medium size (approximately 0.3 g per ball); 100% medical-grade absorbent cotton; Autoclave sterilized
Examination gloves,disposable	Guangdong Feiyang Medical Supplies Co., Ltd.	Type B (Powder-Free Matte Surface)	Made of natural rubber latex, powder-free; Size: S (small); Non-sterile; Single use only.
Forceps,medical	Shanghai Jinzhong Medical Equipment Co., Ltd.	N/A	Stainless steel; Length: 12.5 cm; Straight tip with serrated grip
Gua Sha oil	Nanjing Tongren Hospital Pharmaceutical Co., Ltd.	N/A	Ingredients: Vegetable oil-based (CAS No. 8007-08-7, 8022-37-5), with a mixture of natural essential oils added at no more than 1%;viscosity:approximately 15 mPa·s at 25 °C;dosage per use: Approximately 5 mL