ISRCTN27075727终止2 期
Anti-TNF (adalimumab) injection for the treatment of adults with frozen shoulder during the pain-predominant phase: a multi-centre, randomised, double blind, parallel group, feasibility study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
研究概览
简要总结
2023 Protocol article in https://doi.org/10.3310/nihropenres.13275.2 (added 09/06/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38692727/ (added 17/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men and women aged 18 years and above.
- •2. With a new episode of shoulder pain attributable to pain-predominant stage of frozen shoulder (i.e. within approximately 3 months of onset of symptoms) diagnosed using criteria set out in the BESS guidelines
- •3. Who are not being considered for surgery;
- •4. Able to understand spoken and written English;
- •5. Willing and able to give informed consent for trial participation and comply with all study requirements and time line;
- •6. Willing to allow his or her General Practitioner be notified of participation in the trial.
- •7. If female and of child-bearing potential OR if male and their partner is of child-bearing potential – willing to use effective contraception throughout the treatment period and for 5 months after the last injection.
排除标准
- •1. Those with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g. recent breast cancer surgery or radiotherapy);
- •2. Those with a neurological disease affecting the shoulder;
- •3. Those with bilateral concurrent frozen shoulder;
- •4. Those with other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out in the BESS guidelines (33);
- •5. Those who have received corticosteroid injection for shoulder pain in the last 12 weeks to either shoulder;
- •6. Those currently taking any anti-TNF drug;
- •7. Those being treated with coumarin anticoagulants, such as warfarin;
- •8. Those who have participated in another research study involving an investigational medicinal product in the past 12 weeks;
- •9. Those with significant renal or hepatic impairment;
- •10. Those with contra-indications to anti-TNF injection:
- •10.1 Known allergy to any anti-TNF agent or any of the excipients;
- •10.2 Known Active tuberculosis (TB) or history of TB.
- •10.3 Known Active infection (chronic or localised) or known history of recurring infections or condition which may predispose patients to infection, including the use of concomitant immunosuppressive medications;
- •10.4 Known Moderate to severe heart failure (NYHA class III/IV);
- •10.5 Those known to have HIV, Hepatitis B or C;
- •10.6 Those at risk of Hepatitis B infection;
- •10.7 Those diagnosed with Multiple Sclerosis (MS) or other central or peripheral nervous system demyelinating disorders;
- •10.8 Those who have ever been diagnosed with cancer, except basal cell carcinoma (BCC);
- •10.9 Those requiring live vaccination prior towithin 12 weeks after of the last trial injection or within the 4 weeks prior to randomisation;
- •10.10 Those taking biologic DMARDS;
- •10.11 Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
研究者
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