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)
Primary Purpose
Shoulder Impingement Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LAENNEC
0.9% normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome
Eligibility Criteria
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
15. Those who determine that other testors are inadequate
Sites / Locations
- Keimyung University Dongsan Hospital
- Chung-Ang University Gwangmyeong Hospital
- Chung-Ang University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LAENNEC
0.9% Normal saline
Arm Description
4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment
4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment
Outcomes
Primary Outcome Measures
Change amoust of VAS (visual analogue scale)
Secondary Outcome Measures
Change amoust of VAS (visual analogue scale)
Change amoust of SPADI
Change amoust of EQ-5D-5L
Full Information
NCT ID
NCT05528705
First Posted
September 1, 2022
Last Updated
January 31, 2023
Sponsor
Green Cross Wellbeing
Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05528705
Brief Title
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
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Wellbeing
Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAENNEC
Arm Type
Experimental
Arm Description
4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment
Arm Title
0.9% Normal saline
Arm Type
Active Comparator
Arm Description
4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment
Intervention Type
Biological
Intervention Name(s)
LAENNEC
Other Intervention Name(s)
Human Placenta Hydrolysate
Intervention Description
Subacromial spatial administration
Intervention Type
Other
Intervention Name(s)
0.9% normal saline
Intervention Description
Subacromial spatial administration
Primary Outcome Measure Information:
Title
Change amoust of VAS (visual analogue scale)
Time Frame
week 0 and 12
Secondary Outcome Measure Information:
Title
Change amoust of VAS (visual analogue scale)
Time Frame
week 1, 2, 3 and 6
Title
Change amoust of SPADI
Time Frame
week 1, 2, 3, 6 and 12
Title
Change amoust of EQ-5D-5L
Time Frame
week 1, 2, 3, 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
15. Those who determine that other testors are inadequate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeongmin Kwon
Phone
+82-70-8892-7881
Email
ymkwon@gccorp.com
Facility Information:
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chul-Hyun Cho, Ph.D
Facility Name
Chung-Ang University Gwangmyeong Hospital
City
Gwangmyeong
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Don-Kyu Kim, Ph. D
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Du Hwan Kim, Ph.D.
First Name & Middle Initial & Last Name & Degree
Du Hwan Kim, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
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
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