CTRI/2024/06/069688尚未招募4 期
A Prospective, Multicenter, Open-label, Post-Marketing Observational Study to Evaluate the Effectiveness and Safety of Triamcinolone Hexacetonide Intra-Articular Injection in Adhesive Capsulitis of the Shoulder (Frozen Shoulder) - NI
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male and female subjects aged =18 years.
- •2. Have been symptomatic for adhesive capsulitis of the shoulder for less than 1 year.
- •3. Should have a diagnosis of adhesive capsulitis as per the Investigator’s discretion
- •4. Patients with a total score of =30 on the SPADI.
- •5. Patients are willing and able to comply with the study procedures and sign the patient authorization form.
- •6. Patients who have been prescribed a single USG guided intra-articular injection of triamcinolone hexacetonide 20 or 40 mg for the treatment of frozen shoulder, as part of routine clinical practice.
排除标准
- •1. Adhesive capsulitis is secondary to another cause, including inflammatory, degenerative, metabolic, or infectious arthritis, cerebrovascular accident, dislocation or fracture
- •2. Significant (requiring surgical correction) deformity of the target joint.
- •3. Concomitant inflammatory or any other disease/condition which may affect joints (e.g metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.).
- •4. History of sepsis in the target joint or any clinical concern for acute or sub-acute infectious process in the target joint e.g. active tuberculosis, herpes simplex keratitis, systemic mycoses and parasitoses (strongyloid infections).
- •5. Clinically apparent tense effusion at the target joint.
- •6. Skin disease or infection in the area of the injection site.
- •7. Arthrocentesis in the past 3 months.
- •8. Allergic to the study drug or any of the other ingredients.
- •9. Participation in any other clinical study in the past 30 days.
- •10. Patients who had received intra-articular and/or periarticular systemic steroids in the previous 3 months.
- •11. Any contraindication to intra-articular and/or periarticular injection.
- •12. Females with child-bearing potential who are pregnant or planning to become pregnant or are not ready to use contraceptive measures or are lactating.
- •13. Patients with any other disease/comorbidities which may be exacerbated with THA administration as per Investigator discretion.
- •14. Patient with known blood coagulation disorder
研究者
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