Clinical trial NCT05528705: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: Green Cross Wellbeing
Sponsor class: INDUSTRY
Collaborators: name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
First posted: 2022-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change amoust of VAS (visual analogue scale)
timeFrame: week 0 and 12
Secondary outcomes:
measure: Change amoust of VAS (visual analogue scale)
timeFrame: week 1, 2, 3 and 6
measure: Change amoust of SPADI
timeFrame: week 1, 2, 3, 6 and 12
measure: Change amoust of EQ-5D-5L
timeFrame: week 1, 2, 3, 6 and 12
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References: