Shoulder Impingement SyndromePAINNCT05528705
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
A study testing LAENNEC and 0.9% normal saline in people with Shoulder Impingement Syndrome, run by Green Cross Wellbeing at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- LAENNEC and 0.9% normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 13 Sep 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Keimyung University Dongsan Hospital
Daegu
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Chung-Ang University Hospital
Seoul
About this study
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
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.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- LAENNEC, 0.9% normal saline
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAENNECBiological
Also called Human Placenta Hydrolysate
Subacromial spatial administration
0.9% normal salineOther
Subacromial spatial administration
| Study group | Role | What they receive |
|---|---|---|
| LAENNEC | Experimental | 4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment Receives: Biological: LAENNEC |
| 0.9% Normal saline | Active comparator | 4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment Receives: Other: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change amoust of VAS (visual analogue scale)
Measured: week 0 and 12
Secondary outcomes (3)
Change amoust of VAS (visual analogue scale)
Measured: week 1, 2, 3 and 6
Change amoust of SPADI
Measured: week 1, 2, 3, 6 and 12
Change amoust of EQ-5D-5L
Measured: week 1, 2, 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start13 Sep 2022
- Primary completion23 Oct 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Wellbeing
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chung-Ang University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528705
- Sponsor's protocol ID
- LAEN-PAIN
- Acronym
- PAIN
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim DH, Park MW, Shin HI, Lee BC, Kim DK, Cho CH, Kim YJ. Effectiveness and safety of human placenta hydrolysate injection into subacromial space in patients with shoulder impingement syndrome: a single-blind, randomized trial. BMC Musculoskelet Disord. 2025 Jan 3;26(1):11. doi: 10.1186/s12891-024-08266-4.
PubMed 39754114
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05528705
- Acronym / sponsor ID
- PAIN / LAEN-PAIN
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Green Cross WellbeingIndustry (pharma, biotech, devices)
- Collaborators
- Chung-Ang University Hospital
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAENNEC | Experimental | Biological: LAENNEC4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment |
| 0.9% Normal saline | Active comparator | Other: 0.9% normal saline4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAENNECAlso: Human Placenta HydrolysateSubacromial spatial administration | Biological | LAENNEC |
| 0.9% normal salineSubacromial spatial administration | Other | 0.9% Normal saline |
Primary outcome
Change amoust of VAS (visual analogue scale)
Time frame: week 0 and 12
3 secondary outcomes
Change amoust of VAS (visual analogue scale)
Time frame: week 1, 2, 3 and 6
Change amoust of SPADI
Time frame: week 1, 2, 3, 6 and 12
Change amoust of EQ-5D-5L
Time frame: week 1, 2, 3, 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 39754114Kim DH, Park MW, Shin HI, Lee BC, Kim DK, Cho CH, Kim YJ. Effectiveness and safety of human placenta hydrolysate injection into subacromial space in patients with shoulder impingement syndrome: a single-blind, randomized trial. BMC Musculoskelet Disord. 2025 Jan 3;26(1):11. doi: 10.1186/s12891-024-08266-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAENNEC and 0.9% normal saline in people with Shoulder Impingement Syndrome, run by Green Cross Wellbeing at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change amoust of VAS (visual analogue scale) (time frame: week 0 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.