Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome

Shoulder Impingement Syndrome Clinical Trial

— PAIN  

Official title:

A Randomized, Parallel-group, Placebo-controlled, Single-blind, Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528705
• Other study ID #: LAEN-PAIN
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: September 2022
• Source: Green Cross Wellbeing
• Contact: Yeongmin Kwon
• Phone: +82-70-8892-7881
• Email: ymkwon[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To patients with shoulder collision syndrome, LAENNEC (Human Placenta Hydrolysate) is administered as an injection in the ultrasonic induction underglone, to evaluate the effectiveness and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. At the time of screening, 19 or 70 years

2. Those who are suspected of rotator cuff lesions or damage due to shoulder pain

3. Those who are judged to have a shoulder joint disease during screening

4. Neer test, Hawkins-Kennedy inspection, job test, Painful Arc inspection or resisted showder external rotation test

5. Those with a significant pain of 30 mm of Visual Analogue Scale (VAS)

6. Those who can sign a test subject or to comply with the matters required for clinical trials.

Exclusion Criteria:

1. A person who appears in the movement of two or more shoulder joints with more than 50% of the joint movement limit on the passive shoulder joint operation scope test.

2. Those who have confirmed the rupture of the entire layer by ultrasound

3. Those with serious damage to the shoulders and the past power

4. Those who have suspected fractures, dislocations, degenerative arthritis, and calcification in the shoulder radiation test in the shoulder radiation test.

5. Those who complain of shoulder pain due to stroke, spinal cord injury, and other surgery

6. Those with other shoulder diseases other than fifty dogs (rheumatoid arthritis, osteoarthritis, bone defect injuries, malignant tumors, etc.)

7. Those who are accompanied by diseases of cervical spine or other upper limbs that have a significant effect on the shoulder

8. Those who have performed steroid injections in the joint steel within 3 months of participation in clinical trials

9. Those who have administered anti -inflammatory drugs within two weeks of participation in clinical trials

10. Those with all other joint diseases that have musculoskeletal diseases that may affect effective evaluation, or that it is impossible to participate in this clinical trial.

11. Those who are diagnosed with mental illness and taking drugs

12. Pregnant women and lactation departments, fertility women who are not willing to contraceptive during the clinical trial period

13. Those who have received medication, oriental medicine, physical therapy, and injection treatment in relation to shoulder pain within the last two weeks 14 Those who are participating in other clinical trials during screening

15. Those who determine that other testors are inadequate

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Syndrome

Intervention

Biological:
• LAENNEC
Subacromial spatial administration

Other:
• 0.9% normal saline
Subacromial spatial administration

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Chung-Ang University Gwangmyeong Hospital	Gwangmyeong
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Green Cross Wellbeing	Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change amoust of VAS (visual analogue scale)		week 0 and 12
Secondary	Change amoust of VAS (visual analogue scale)		week 1, 2, 3 and 6
Secondary	Change amoust of SPADI		week 1, 2, 3, 6 and 12
Secondary	Change amoust of EQ-5D-5L		week 1, 2, 3, 6 and 12