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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Shoulder Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LAENNEC

4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment

Group Type EXPERIMENTAL

LAENNEC

Intervention Type BIOLOGICAL

Subacromial spatial administration

0.9% Normal saline

4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment

Group Type ACTIVE_COMPARATOR

0.9% normal saline

Intervention Type OTHER

Subacromial spatial administration

Interventions

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LAENNEC

Subacromial spatial administration

Intervention Type BIOLOGICAL

0.9% normal saline

Subacromial spatial administration

Intervention Type OTHER

Other Intervention Names

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Human Placenta Hydrolysate

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No