Study to evaluate safety and effectiveness of injection for patients seeking treatment for Frozen Shoulder
- Conditions
- Health Condition 1: M750- Adhesive capsulitis of shoulder
- Registration Number
- CTRI/2024/06/069688
- Lead Sponsor
- Abbott India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the total SPADI score from baseline to Week 4Timepoint: Change in the total SPADI score from baseline to Week 4
- Secondary Outcome Measures
Name Time Method • Change in the total SPADI score from baseline to Weeks 1, 8, and 12. <br/ ><br>• Change in SPADI subscale of pain score from baseline to Weeks 1, 4, 8, and 12. <br/ ><br>• Change in SPADI subscale of disability score from baseline to Weeks 1, 4, 8, and 12.Timepoint: 1, 4, 8 and 12 weeks