Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy

Pharmacological Action Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222710
• Other study ID #: JS-CT-2023-04
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Jaseng Medical Foundation
• Contact: Sunah Kim, KMD
• Phone: 82-42-1577-0007
• Email: tnsdk2648[@]jaseng.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacological Action
• Tendinopathy

Intervention

Procedure:
• Pharmacoacupuncture with ultrasound guiding
Physician choose the adequate type and dose of pharmacoacupuncture and needle type with ultrasound guiding
• Pharmacoacupuncture without ultrasound guiding
Physician choose the adequate type and dose of pharmacoacupuncture and needle type without ultrasound guiding

Locations

Country	Name	City	State
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain numeric rating scale, NRS	The intensity of spinal pain during the first week will be assessed using the NRS. In the NRS, patients choose a number from 0 to 10 that best describes their comfort (0 being no pain and 10 being the most comfortable they can imagine).	Week 1,2,3,4,5,6,7,13
Secondary	Shoulder Pain And Disability Index, SPADI	The functional status of study subjects will be assessed using the SPADI questionnaire. SPADI is a 13-item questionnaire developed to assess the degree of disability related to shoulder pain. Each question is divided into 10 levels and consists of 5 questions in the pain evaluation section and 8 questions in the functional disability evaluation section. The higher the score, the more severe the disability. We will conduct an accredited Korean SPADI survey.	Week 1,7,13
Secondary	Range of motion, ROM	Active and passive ROM will be measured before and after treatment to evaluate the degree of improvement after treatment. ROM is evaluated by measuring the angle between the subject's upper limb and an imaginary line drawn vertically from the ground in the maximum range of motion of the subject's shoulder joint in flexion, extension, abduction, adduction, external rotation, and internal rotation. If measurement is not possible due to pain, it will be recorded as UC.	Week 1,2,3,4,5,6,7,13
Secondary	Neer test	Neer test is performed to evaluate the diagnostic significance before treatment and the degree of improvement after treatment. If measurement is not possible due to pain, it will be recorded as UC.	Week 1,2,3,4,5,6,7,13
Secondary	Empty can test	Empty can test is performed to evaluate the diagnostic significance before treatment and the degree of improvement after treatment. If measurement is not possible due to pain, it will be recorded as UC.	Week 1,2,3,4,5,6,7,13
Secondary	Full can test	Full can test is performed to evaluate the diagnostic significance before treatment and the degree of improvement after treatment. If measurement is not possible due to pain, it will be recorded as UC.	Week 1,2,3,4,5,6,7,13
Secondary	Hawkin's test	Hawkin's test is performed to evaluate the diagnostic significance before treatment and the degree of improvement after treatment. If measurement is not possible due to pain, it will be recorded as UC.	Week 1,2,3,4,5,6,7,13
Secondary	EuroQol-5 Dimension, EQ-5D-5L	EQ-5D-5L is a method of evaluating health status from various aspects and then indirectly calculating the quality weight of a specific health status using pre-assigned preference scores for each functional level. It is the most widely used among several indirect measurement methods. there is. The EQ-5D-5L consists of 5 questions. Each question includes mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Ask about the degree of depression, etc. Each item is weighted according to its level, and the preference score calculation equation is presented based on these weights and constants.	Week 1,7,13
Secondary	Patient Global Impression of Change, PGIC	This is a method that allows the patient to subjectively evaluate the degree of improvement on a 7-level scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.	Week 7,13
Secondary	Muscle test	To evaluate the degree of improvement in rotator cuff strength as shoulder stability is restored, the strength during external and internal rotation of the shoulder joint is compared with the healthy side. If measurement is not possible due to pain, it will be recorded as UC.	Week 1,2,3,4,5,6,7,13