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)
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in the total SPADI score from baseline to Week 4
研究概览
简要总结
This is an observational, non-interventional study that will be conducted in 3 to 4 centers in India.
Patients seeking treatment for frozen shoulder and prescribed USG guided intra-articular injection
of triamcinolone hexacetonide at the respective study sites will be consecutively enrolled in the
study after assessment of eligibility criteria.
This multicenter study will enroll 60 patients, with Adhesive Capsulitis of the Shoulder (Frozen Shoulder). The study will consist of a total of 5 visits. At the first visit, the subject will receive the study
medication followed by 4 follow-up visits. The selection of patients for the study will be totally at the discretion of the investigator, and as per the study protocol. All the patients diagnosed with symptoms of Adhesive Capsulitis of the Shoulder (Frozen Shoulder), meeting inclusion and exclusion criteria, and ready to give written informed consent for study participation, are eligible for participation in this study. The study is planned to be conducted for approximately Six (6)- months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged ≥18 years.
- •Have been symptomatic for adhesive capsulitis of the shoulder for less than 1 year.
- •Should have a diagnosis of adhesive capsulitis as per the Investigator’s discretion
- •Patients with a total score of ≥30 on the SPADI.
- •Patients are willing and able to comply with the study procedures and sign the patient authorization form.
- •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
- •Adhesive capsulitis is secondary to another cause, including inflammatory, degenerative, metabolic, or infectious arthritis, cerebrovascular accident, dislocation or fracture
- •Significant (requiring surgical correction) deformity of the target joint.
- •Concomitant inflammatory or any other disease/condition which may affect joints (e.g metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.).
- •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).
- •Clinically apparent tense effusion at the target joint.
- •Skin disease or infection in the area of the injection site.
- •Arthrocentesis in the past 3 months.
- •Allergic to the study drug or any of the other ingredients.
- •Participation in any other clinical study in the past 30 days.
- •Patients who had received intra-articular and/or periarticular systemic steroids in the previous 3 months.
- •Any contraindication to intra-articular and/or periarticular injection.
- •Females with child-bearing potential who are pregnant or planning to become pregnant or are not ready to use contraceptive measures or are lactating.
- •Patients with any other disease/comorbidities which may be exacerbated with THA administration as per Investigator discretion.
- •Patient with known blood coagulation disorder.
结局指标
主要结局
Change in the total SPADI score from baseline to Week 4
时间窗: Change in the total SPADI score from baseline to Week 4
次要结局
- • Change in the total SPADI score from baseline to Weeks 1, 8, and 12.(• Change in SPADI subscale of pain score from baseline to Weeks 1, 4, 8, and 12.)
研究者
Dr Shivani Acharya
Abbott India Limited