Clinical trial NCT06222710: Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy
Official title: Pragmatic Randomized Controlled Trial of Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pharmacological Action
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Those between 19 and 70 years of age.
* Those whose NRS (Numeric Rating Scale) of shoulder joint pain is 5 or higher and who complain of pain when abducting.
* When supraspinatus tendinopathy is confirmed on MRI.
* Those whose symptoms above last for more than 1 month.
* Those who agree to participate in clinical research and provide written test subject consent.

Exclusion Criteria:

* For patients diagnosed with a specific serious disease that may cause shoulder pain (acute fracture, dislocation of the shoulder, complete rupture of rotator cuff, etc.)
* For patients whose pain was caused by a condition other than the shoulder (tumor, fibromyalgia, rheumatoid arthritis, gout, cervical disc herniation, etc.)
* In patients with other chronic conditions (such as stroke and myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with treatment effectiveness or interpretation of outcomes
* Patients currently taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect their findings
* Inadequate or unsafe medication: hemorrhagic disease, anticoagulant therapy, severe diabetic patients with risk of infection
* Patients who have taken drugs that can affect pain such as non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or have experienced acupuncture treatment
* For patients who have received steroid injections within the last 3 months
* In the case of pregnant women and in the case of planning to become pregnant or nursing
* For patients within 6 months of shoulder surgery
* If it has not been one month since the end of participation in other clinical studies, or if you are planning to participate in other clinical studies within six months from the date of selection and participate in other clinical studies during the follow-up period
* If it is difficult to fill out a consent form to participate in the study
* In cases where it is difficult for other researchers to participate in clinical research

Primary outcomes:
measure: Shoulder pain numeric rating scale, NRS
timeFrame: Week 1,2,3,4,5,6,7,13
Secondary outcomes:
measure: Shoulder Pain And Disability Index, SPADI
timeFrame: Week 1,7,13
measure: Range of motion, ROM
timeFrame: Week 1,2,3,4,5,6,7,13
measure: Neer test
timeFrame: Week 1,2,3,4,5,6,7,13
measure: Empty can test
timeFrame: Week 1,2,3,4,5,6,7,13
measure: Full can test
timeFrame: Week 1,2,3,4,5,6,7,13
measure: Hawkin's test
timeFrame: Week 1,2,3,4,5,6,7,13
measure: EuroQol-5 Dimension, EQ-5D-5L
timeFrame: Week 1,7,13
measure: Patient Global Impression of Change, PGIC
timeFrame: Week 7,13
measure: Muscle test
timeFrame: Week 1,2,3,4,5,6,7,13
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Daejeon Jaseng Hospital of Korean Medicine
name: Sunah Kim, KMD
role: PRINCIPAL_INVESTIGATOR
References: