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 (PAIN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Biological: LAENNEC; Other: 0.9% normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: Du Hwan Kim, Ph.D.
    • Principal Investigator: Du Hwan Kim, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAENNEC; 4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment	Biological: LAENNEC; Subacromial spatial administration; Other Names: Human Placenta Hydrolysate
Active Comparator: 0.9% Normal saline; 4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment	Other: 0.9% normal saline; Subacromial spatial administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change amoust of VAS (visual analogue scale)	week 0 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change amoust of VAS (visual analogue scale)	week 1, 2, 3 and 6
Change amoust of SPADI	week 1, 2, 3, 6 and 12
Change amoust of EQ-5D-5L	week 1, 2, 3, 6 and 12

Collaborators and Investigators

• Sponsor: Green Cross Wellbeing
• Collaborators: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: LAEN-PAIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No