NCT06222710

Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy

Pragmatic Randomized Controlled Trial of Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Jaseng Medical Foundation · Academic / Other
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the comparative effect and accuracy of ultrasound procedures by conducting a practical randomized controlled clinical study comparing patients (20 patients) with ultrasound-guided pharmacoacupuncture and patients (20 patients) without checking ultrasound images in 40 patients with whom complain of moderate or higher pain with 5 or higher NRS when stabilizing the shoulder joint.

Detailed description

This clinical study is conducted for the purpose of research, and it is a practical clinical study to confirm the comparative effect by comparing the strategy of treating patients with extreme myopathy (more than a month after the onset of symptoms) with ultrasound-guided acupuncture. Supraspinatus tendonopathy is the most common of rotator cuff tendonopathy, which occurs most frequently among shoulder diseases. Inflammation of joints, muscles, and tendons often means tendinitis. Pain within a few days of acute manifestation can be diagnosed as tendinitis, but if it is older than a few months, degenerative changes in tissues may be the main cause rather than inflammation, and in this case, it is called tendinosis. Clinically, the line between tendinitis and tendinosis is unclear, and it is collectively referred to as tendinopathy because it is a series of successive pathological processes. Rotator cuff refers to the four muscles: hypertrophy, hypertrophy, distal, and subscapular muscles, which play the most important role in rotator cuff. About 95% of the muscles, when they lift their arms to the side or forward, regression occurs in the hypertrophy due to the anatomical structure, and it progresses to rupture when continuous regression or strong trauma occurs. Due to the anatomical characteristics, conservative treatment is strong in that the pain area is persistent and the risk of recurrence is high when the arm is moved. Pharmacopuncture is a combination of acupuncture and drug therapy, which diagnoses a patient's constitution and disease condition and injects a certain amount of drugs extracted from specific herbal medicines into the treatment area to treat the disease. Ultrasound medical devices have the advantage of being able to perform high sensitivity, specificity, and dynamic tests, and being an inducer of not only diagnosis but also interventional treatment, allowing accurate procedures in real time without radiation exposure. In this study, 40 patients with external pain in their shoulders and symptoms lasting more than a month will be assigned to 20 patients who are treated with ultrasound-guided acupuncture and 20 patients who are treated with acupuncture using tactile acupuncture. The recruitment of patients will be conducted in non-competitive recruitment and will be conducted until the recruitment of all patients (40 patients) is completed. According to the schedule, patients will visit for a total of 12 treatments over a six-week period until the end of participation. After that, a total of two visits (weeks 7 and 13) will be made over a seven-week follow-up period.

Conditions

• Pharmacological Action

Interventions

Type	Name	Description
PROCEDURE	Pharmacoacupuncture with ultrasound guiding	Physician choose the adequate type and dose of pharmacoacupuncture and needle type with ultrasound guiding
PROCEDURE	Pharmacoacupuncture without ultrasound guiding	Physician choose the adequate type and dose of pharmacoacupuncture and needle type without ultrasound guiding

Timeline

• Start date: 2023-12-20
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2024-01-25
• Last updated: 2026-03-10

Locations

1 site across 1 country: South Korea