Injecting Atelocollagen to Treat Shoulder Tendinitis
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis
This study is testing if atelocollagen injections can help people with shoulder tendinitis feel better compared to a standard treatment with lidocaine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 20 Years to 69 Years |
| Sex | All |
| Sponsor | The Catholic University of Korea Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06040112 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of atelocollagen injections in patients suffering from calcific tendinitis of the shoulder. Participants will be randomly assigned to receive either an ultrasound-guided barbotage followed by atelocollagen injection or a control treatment with lidocaine injection. The study aims to assess clinical outcomes and functional scores six months after the injection. The goal is to determine if atelocollagen can improve patient outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with calcification of 5mm or more in their shoulder as observed in plain radiographs.
Not a fit: Patients with a history of infectious arthritis, autoimmune diseases, or allergies to porcine proteins may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with calcific tendinitis, potentially leading to improved shoulder function and pain relief.
How similar studies have performed: While the use of atelocollagen is a novel approach in this context, similar studies have shown promising results with other injection therapies for tendinitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Patients in whom calcification of 5mm or more is observed in plain radiographs.
2. In cases where concomitant medication is administered continuously during the clinical trial period, patients who have verified the exact prescribed medication taken within the last week and agreed to maintain the same amount throughout the study period.
3. Individuals who have agreed to participate in this study and have given written consent themselves.
Exclusion Criteria:
* Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.
* Patients with hypersensitivity.
* Patients with a history of anaphylactic reactions.
* Patients with ongoing autoimmune diseases or a past medical history of such diseases, either in the patient or their family members.
* Patients who are allergic to transplants. ⑥ Patients who are allergic to porcine (pig) proteins.
⑦ Patients deemed unsuitable for this trial based on the judgment of the trial administrator, such as those with mental illnesses.
⑧ Patients who have received intra-articular steroid or other injection treatments within one month prior to the procedure decision.
⑨ Patients who are on concomitant medications that include oral steroids.
Where this trial is running
Seoul
- Eunpyeong St. Mary's Hospital, The Catholic University of Korea — Seoul, Korea, Republic of (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.