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Completed

NCT Number: 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

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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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University Dongsan Hospital, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At the time of screening, 19 or 70 years
  • Those who are suspected of rotator cuff lesions or damage due to shoulder pain
  • Those who are judged to have a shoulder joint disease during screening
  • Neer test, Hawkins-Kennedy inspection, job test, Painful Arc inspection or resisted showder external rotation test
  • Those with a significant pain of 30 mm of Visual Analogue Scale (VAS)
  • Those who can sign a test subject or to comply with the matters required for clinical trials.

Exclusion criteria

  • 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.
  • Those who have confirmed the rupture of the entire layer by ultrasound
  • Those with serious damage to the shoulders and the past power
  • Those who have suspected fractures, dislocations, degenerative arthritis, and calcification in the shoulder radiation test in the shoulder radiation test.
  • Those who complain of shoulder pain due to stroke, spinal cord injury, and other surgery
  • Those with other shoulder diseases other than fifty dogs (rheumatoid arthritis, osteoarthritis, bone defect injuries, malignant tumors, etc.)
  • Those who are accompanied by diseases of cervical spine or other upper limbs that have a significant effect on the shoulder
  • Those who have performed steroid injections in the joint steel within 3 months of participation in clinical trials
  • Those who have administered anti -inflammatory drugs within two weeks of participation in clinical trials
  • 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.
  • Those who are diagnosed with mental illness and taking drugs
  • Pregnant women and lactation departments, fertility women who are not willing to contraceptive during the clinical trial period
  • 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
  • Those who determine that other testors are inadequate

Treatment and study plan

LAENNEC

Biological

Subacromial spatial administration

Other names: Human Placenta Hydrolysate

0.9% normal saline

Other

Subacromial spatial administration

Primary outcomes

  1. Change amoust of VAS (visual analogue scale)

    Time frame: week 0 and 12

Secondary outcomes

  1. Change amoust of VAS (visual analogue scale)

    Time frame: week 1, 2, 3 and 6

  2. Change amoust of SPADI

    Time frame: week 1, 2, 3, 6 and 12

  3. Change amoust of EQ-5D-5L

    Time frame: week 1, 2, 3, 6 and 12

Sponsors and collaborators

Lead sponsor

Green Cross Wellbeing

Industry

Collaborators

  • Chung-Ang University Hospital

Registry information

Official study 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

Acronym: PAIN

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 6, 2022
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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