Ultrasound Guiding Pharmacopuncture Therapy for Supraspinatus Tendinopathy

NCT06222710 | Completed DMC

• 1 other identifier: JS-CT-2023-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Shoulder Pain And Disability Index, SPADI

  Week 1,7,13

• Range of motion, ROM

  Week 1,2,3,4,5,6,7,13

• Neer test

  Week 1,2,3,4,5,6,7,13

• Empty can test

  Week 1,2,3,4,5,6,7,13

• Full can test

  Week 1,2,3,4,5,6,7,13

Study Arms (2)

Patients with ultrasound-guided pharmacoacupuncture

EXPERIMENTAL

20 patients with ultrasound-guided pharmacoacupuncture

Procedure: Pharmacoacupuncture with ultrasound guiding

Patients with blind pharmacoacupuncture

ACTIVE COMPARATOR

20 patients who treat pharmacoacupuncture without checking ultrasound images

Procedure: Pharmacoacupuncture without ultrasound guiding

Interventions

Pharmacoacupuncture with ultrasound guiding PROCEDURE

Physician choose the adequate type and dose of pharmacoacupuncture and needle type with ultrasound guiding

Patients with ultrasound-guided pharmacoacupuncture

Pharmacoacupuncture without ultrasound guiding PROCEDURE

Physician choose the adequate type and dose of pharmacoacupuncture and needle type without ultrasound guiding

Patients with blind pharmacoacupuncture

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

Location

Study Officials

• Sunah Kim, KMD

  Daejeon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 25, 2024
• Study Start: December 20, 2023
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)