Pharmacological ActionNCT06222710
Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy
A study testing Pharmacoacupuncture with ultrasound guiding and Pharmacoacupuncture without ultrasound guiding in people with Pharmacological Action, run by Jaseng Medical Foundation at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Pharmacoacupuncture with ultrasound guiding and Pharmacoacupuncture without ultrasound guiding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2023to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Randomized Controlled Trial of Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy: a Pilot Study
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.
Read the 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
- Being tested
- Pharmacoacupuncture with ultrasound guiding, Pharmacoacupuncture without ultrasound guiding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacoacupuncture with ultrasound guidingProcedure or surgery
Physician choose the adequate type and dose of pharmacoacupuncture and needle type with ultrasound guiding
Pharmacoacupuncture without ultrasound guidingProcedure or surgery
Physician choose the adequate type and dose of pharmacoacupuncture and needle type without ultrasound guiding
| Study group | Role | What they receive |
|---|---|---|
| Patients with ultrasound-guided pharmacoacupuncture | Experimental | 20 patients with ultrasound-guided pharmacoacupuncture Receives: Procedure: Pharmacoacupuncture with ultrasound guiding |
| Patients with blind pharmacoacupuncture | Active comparator | 20 patients who treat pharmacoacupuncture without checking ultrasound images Receives: Procedure: Pharmacoacupuncture without ultrasound guiding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 1,2,3,4,5,6,7,13
Secondary outcomes (9)
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.
Measured: Week 1,7,13
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.
Measured: Week 1,2,3,4,5,6,7,13
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.
Measured: Week 1,2,3,4,5,6,7,13
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.
Measured: Week 1,2,3,4,5,6,7,13
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.
Measured: Week 1,2,3,4,5,6,7,13
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.
Measured: Week 1,2,3,4,5,6,7,13
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.
Measured: Week 1,7,13
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.
Measured: Week 7,13
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.
Measured: Week 1,2,3,4,5,6,7,13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start20 Dec 2023
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunah Kim, KMD, Principal investigator, Daejeon Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222710
- Sponsor's protocol ID
- JS-CT-2023-04
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy: a Pilot Study
- ClinicalTrials.gov ID
- NCT06222710
- Acronym / sponsor ID
- JS-CT-2023-04
- Conditions
- Pharmacological Action
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ultrasound-guided pharmacoacupuncture | Experimental | Procedure: Pharmacoacupuncture with ultrasound guiding20 patients with ultrasound-guided pharmacoacupuncture |
| Patients with blind pharmacoacupuncture | Active comparator | Procedure: Pharmacoacupuncture without ultrasound guiding20 patients who treat pharmacoacupuncture without checking ultrasound images |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacoacupuncture with ultrasound guidingPhysician choose the adequate type and dose of pharmacoacupuncture and needle type with ultrasound guiding | Procedure or surgery | Patients with ultrasound-guided pharmacoacupuncture |
| Pharmacoacupuncture without ultrasound guidingPhysician choose the adequate type and dose of pharmacoacupuncture and needle type without ultrasound guiding | Procedure or surgery | Patients with blind pharmacoacupuncture |
Primary outcome
Shoulder pain numeric rating scale, NRS
Time frame: Week 1,2,3,4,5,6,7,13
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).
9 secondary outcomes
Shoulder Pain And Disability Index, SPADI
Time frame: Week 1,7,13
Range of motion, ROM
Time frame: Week 1,2,3,4,5,6,7,13
Neer test
Time frame: Week 1,2,3,4,5,6,7,13
Empty can test
Time frame: Week 1,2,3,4,5,6,7,13
Full can test
Time frame: Week 1,2,3,4,5,6,7,13
Hawkin's test
Time frame: Week 1,2,3,4,5,6,7,13
EuroQol-5 Dimension, EQ-5D-5L
Time frame: Week 1,7,13
Patient Global Impression of Change, PGIC
Time frame: Week 7,13
Muscle test
Time frame: Week 1,2,3,4,5,6,7,13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunah Kim, KMD principal investigator
Daejeon Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacoacupuncture with ultrasound guiding and Pharmacoacupuncture without ultrasound guiding in people with Pharmacological Action, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain numeric rating scale, NRS (time frame: Week 1,2,3,4,5,6,7,13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.