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

Last updated: May 30, 2024
Sponsor: Green Cross Wellbeing
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

0.9% normal saline

LAENNEC

Clinical Study ID

NCT05528705
LAEN-PAIN
  • Ages 20-70
  • All Genders

Study 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

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 resistedshowder 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 forclinical trials.

Exclusion

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, andcalcification in the shoulder radiation test in the shoulder radiation test.

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

  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 thathave a significant effect on the shoulder

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

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

  10. Those with all other joint diseases that have musculoskeletal diseases that mayaffect effective evaluation, or that it is impossible to participate in thisclinical trial.

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

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

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

  14. Those who determine that other testors are inadequate

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: 0.9% normal saline
Phase:
Study Start date:
September 13, 2022
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • Keimyung University Dongsan Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong,
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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