Electroacupuncture and Cupping for Shoulder Tendinitis

NCT07545785 | Recruiting

• 1 other identifier: 251094 - ĐHYD
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the effectiveness of electroacupuncture combined with vacuum cupping therapy in treating simple periarthritis of the shoulder associated with the traditional medicine syndrome of Qi stagnation and blood stasis. Shoulder periarthritis is a common condition that causes pain, stiffness, and limited movement of the shoulder due to injury or inflammation of the muscles, tendons, ligaments, and surrounding soft tissues. It can interfere with daily activities such as dressing, lifting objects, sleeping, and working. Electroacupuncture is commonly used to relieve shoulder pain and improve shoulder function. Vacuum cupping therapy is another non-drug treatment that may help improve blood circulation, reduce muscle tightness, decrease pain, and improve mobility. However, there is currently limited evidence about whether combining electroacupuncture with vacuum cupping provides better results than electroacupuncture alone in patients with shoulder periarthritis and Qi stagnation-blood stasis syndrome. This study is being conducted to determine whether the combined treatment is more effective and safe. A total of 54 participants with simple shoulder periarthritis and Qi stagnation-blood stasis syndrome will be enrolled in the study. Participants will be randomly assigned to one of two groups: Group 1: treatment with electroacupuncture alone. Group 2: treatment with electroacupuncture combined with vacuum cupping therapy. All participants will also receive advice on shoulder exercises, posture, and daily activities to support recovery. Treatments will be performed by licensed traditional medicine practitioners. Each participant will take part in the study for two weeks. Assessments will be performed before treatment, after one week, and after two weeks. The study will evaluate: Pain intensity using the Visual Analogue Scale (VAS). Shoulder pain and disability using the Shoulder Pain and Disability Index (SPADI). Shoulder range of motion using the McGill-McRomi Range of Motion Index. Any side effects or unwanted events related to treatment. Possible benefits of participating in this study include reduced shoulder pain, improved movement and daily function, and close monitoring by health care professionals. Participants may also benefit from receiving non-drug therapies at no cost during the study period. The findings of this research may help improve future treatment options for patients with shoulder pain. Possible risks of electroacupuncture include mild pain at the needle site, minor bleeding, bruising, dizziness, or fainting. Possible risks of vacuum cupping include temporary discomfort, skin redness, bruising, or mild pain in the treated area. These side effects are usually mild and temporary. If any unexpected problem occurs, participants will receive prompt medical attention. Participation in this study is completely voluntary. Participants may refuse to join or may withdraw from the study at any time without affecting their usual medical care. All personal information collected during the study will remain confidential and will only be used for research purposes.

Conditions

Shoulder Tendinopathy; Shoulder Tendinitis

Keywords

shoulder tendinopathy; Rotator cuff tendinitis; Long head of the biceps tendonitis; Shoulder Tendinitis

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  The Visual Analogue Scale (VAS) is a validated tool used to quantify pain intensity. It consists of a 10cm horizontal line where the 0 cm mark represents "no pain" and the 10 cm mark represents the "worst pain imaginable". How the measure is taken: Participants are instructed to mark a single point on the line that best reflects their current level of shoulder pain. The researcher then measures the distance from the 0 cm starting point to the patient's mark in centimeters to obtain a numerical score. Pain Level Definitions: No pain (0 cm). Mild (1-3 cm): Slight pain that does not significantly interfere with concentration. Moderate (4-6 cm): Noticeable pain that may interfere with daily activities, though the patient can still work. Severe (7-10 cm): Distressing pain that significantly limits daily activities and affects sleep.

  From enrollment to the completion of the 2-week treatment period, with assessments conducted at baseline (T0), after 1 week of intervention (T1), and after 2 weeks of intervention (T2).

Secondary Outcomes (3)

• Shoulder Pain and Disability Index - SPADI.

  Assessment Schedule: Data is collected at three time points: baseline (T0), after 1 week (T1), and after 2 weeks (T2) of the intervention.

• McGill Range of Motion Index - McGill-McRomi.

  From enrollment to the completion of the 2-week treatment period, with assessments conducted at baseline (T0), after 1 week of intervention (T1), and after 2 weeks of intervention (T2).

• Adverse Events

  Adverse events are monitored throughout the 2-week intervention

Study Arms (2)

Electroacupuncture combined with cupping therapy

EXPERIMENTAL

The intervention group receives a combination of Electroacupuncture (EA) and Vacuum Cupping (VC) over a 2-week period (10 sessions total, excluding weekends). Protocol \& Sequence: VC: Performed 3 times over 2 weeks. Cups (4.5cm diameter) are applied at LI15, SI13, SI11, SI10 (affected side), and bilateral BL17 for 5 minutes using 3 manual pumps. Rest: A 10-minute rest period follows cupping. EA: Performed daily (10 sessions). Points LI15, LI14, LI16, SI9, SI11, LU1, LU2, GB21, and BL17 are stimulated using a continuous wave at 10Hz for 20 minutes. Lifestyle modification counseling and exercise guidance: Participants also perform daily 20-minute home exercises (pendulum and ROM) and receive lifestyle counseling, such as avoiding heavy lifting or overhead arm movements.

Procedure: Electroacupuncture; Procedure: Vacuum Cupping Therapy

Electroacupuncture Group

ACTIVE COMPARATOR

Participants in this group receive Electroacupuncture (EA) as the sole primary intervention. Intervention Details: Frequency: Once daily, totaling 10 sessions over 2 weeks (excluding weekends). Duration: 20 minutes per session. Acupoints: LI15 (Jianyu), LI14 (Binao), LI16 (Jugu), SI9 (Jianzhen), SI11 (Tianzong), LU1 (Zhongfu), LU2 (Yunmen), GB21 (Jianjing), and BL17 (Geshu). Technique: A continuous wave at a 10Hz frequency is applied until the patient achieves the "De Qi" sensation (heaviness or distension). Supportive Care (Standardized for both groups): Home Exercises: Daily 20-minute sessions of pendulum and active range-of-motion (ROM) exercises. Lifestyle Counseling: Guidance on ergonomic adjustments, such as avoiding heavy lifting and overhead arm movements. Monitoring: Compliance with exercises is evaluated during each hospital visit

Procedure: Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

Intervention Description: Electroacupuncture Electroacupuncture is administered using the KWD-808I device and sterile, single-use needles (0.30 x 25 mm). The protocol targets a standardized set of acupoints: LI15 (Jianyu), LI14 (Binao), LI16 (Jugu), SI9 (Jianzhen), SI11 (Tianzong), LU1 (Zhongfu), LU2 (Yunmen), GB21 (Jianjing), and BL17 (Geshu). Distinguishing Technical Details: Sensation: Needles are inserted to achieve the "De Qi" sensation (aching, heaviness, or distension). Electrode Pairing: Electrodes are connected in specific pairs: LU1-LU2, LI15-LI16, and SI11-SI9. Waveform \& Frequency: A continuous wave at a 10Hz frequency is used. Intensity is titrated to the patient's maximum comfortable tolerance (distension without sharp pain). Regimen: 20 minutes per session, daily for 10 sessions over 2 weeks (excluding weekends). All procedures are performed by licensed Traditional Medicine physician physicians with over 5 years of experience

Also known as: Vacuum Cupping Therapy

Electroacupuncture Group; Electroacupuncture combined with cupping therapy

Vacuum Cupping Therapy PROCEDURE

Vacuum Cupping Therapy (VCT) VCT uses 4.5 cm diameter cups and a manual pump to create negative pressure. Standardized procedure: Medium suction force (3 manual pumps) is applied for 5 minutes per session. Treatment sequence: VCT is performed first, followed by a 10-minute rest period before electroacupuncture. Acupoint selection: Targets Jianyu (LI15), Quyuan (SI13), Tianzong (SI11), and Naoshu (SI10) on the affected shoulder, plus bilateral Geshu (BL17). Regimen: 3 sessions over a 2-week period with 3-day intervals. Safety: Vaseline is applied to cup rims to ensure a seal and prevent skin irritation. All procedures are conducted by licensed Traditional Medicine physicians with at least 5 years of experience

Electroacupuncture combined with cupping therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 70 years old.
• Pain intensity score on the Visual Analogue Scale (VAS) between 4 and 7.
• Diagnosis of rotator cuff and/or long head of the biceps tendonitis according to the guidelines issued by the Ministry of Health of Vietnam.
• Mechanical pain that increases during movements such as abduction or raising the arm.
• Presence of tender points at the long head of the biceps tendon or supraspinatus tendon .
• Pain that increases during resisted contraction tests, such as the Jobe test or Palm-up test.
• Absence of limitation in the passive range of motion of the shoulder.
• Ultrasound findings showing a hypoechoic tendon or evidence of calcification.
• Absence of motor weakness or paralysis.
• Diagnosis of the TCM syndrome "Qi Stagnation and Blood Stasis"

You may not qualify if:

• Patients who do not agree to participate in the study.
• Diagnosis of pseudo-paralysis, acute calcific periarthritis, or frozen shoulder.
• Shoulder pain caused by cervical nerve root lesions.
• Shoulder pain originating from apical lung tumors, coronary artery disease, or myocardial infarction.
• Specific joint lesions caused by infection, tuberculosis, or rheumatoid arthritis.
• Bone pathologies including fractures, dislocations, or osteonecrosis of the humeral head.
• Shoulder dysfunction resulting from stroke or hemiplegia.
• Women who are pregnant.
• Patients with mental illness.
• Contraindications for vacuum cupping, such as acute skin inflammation, open wounds, or alcohol consumption.
• Contraindications for electroacupuncture, including cardiac pacemakers, heart failure, or local skin ulcers.
• Current participation in another intervention study.
• Use of painkillers, muscle relaxants, or within the last week.
• Use of anticoagulants or a history of hemophilia.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (2)

Le Van Thinh Hospital

Ho Chi Minh City, 71322, Vietnam

RECRUITING

Ho Chi Minh City Orthopedic and Rehabilitation Hospital

Ho Chi Minh City, 72121, Vietnam

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

HUY HOANG LAM, Doctor

CONTACT

+ 84 933 - 887 - 373; huymhd159@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)