ISRCTN50550256已完成未知
For patients with painful hip OA; comparing 1) best current treatment plus an ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40mg) with 1% lidocaine hydrochloride with either 2) best current treatment alone or 3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride. a randomised, clinical, single-blind, three-arm, parallel group pragmatic trial in patients with hip OA with a linked qualitative study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 199
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30021588 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35387783/ (added 18/08/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37905905/ qualitative interview data (added 01/11/2023) 2023 Results article in https://doi.org/10.1093/rheumatology/kead659 Cost-effectiveness (added 13/12/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female aged =40 years
- •2. A clinical diagnosis of unilateral or bilateral hip OA, and confirmed on plain radiography within the last 24 months, as made by a trained clinician in the musculoskeletal service
- •3. Moderate to severe current hip pain
- •4. Symptom duration of episode of at least 6 weeks
- •5. Hip pain occurring on most days of the last month
- •6. Informed written consent provided by the patient
排除标准
- •1. Hip pain due to other disorders (e.g. trochanteric bursitis, avascular necrosis, pain referred from back)
- •2. Intra-articular corticosteroid injection into the affected hip or ipsilateral trochanteric bursa injection within the preceding 3 months
- •3. Any previous surgery on the affected hip
- •4. Clinical suspicion of local or systemic sepsis or infection
- •5. Current or previous infection of the affected hip
- •6. Significant trauma to the affected hip requiring immobilisation in the previous 3 months
- •7. Unwillingness to undergo study interventions
- •8. Unable to understand and complete self-report questionnaires written (or spoken) in English
- •9. Significant illness (known or suspected) including, but not limited to:
- •9.1. Inflammatory joint disease (e.g. rheumatoid arthritis, seronegative spondyloarthropathy (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory-bowel disease associated inflammatory arthritis))
- •9.2. Polymyalgia rheumatica or other condition requiring regular oral steroid use
- •9.3. Malignancy (where malignancy is thought to be causing hip pain e.g. suspected bony metastases)
- •9.4. Any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation
- •10. Pregnant or lactating females
- •11. Receiving anticoagulants (warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin)
- •12. Any history of hypersensitivity to triamcinolone acetonide or 1% lidocaine hydrochloride or any of their excipients (1N Hydrochloric Acid QS, 1N Sodium Hydroxide QS, Benzyl alcohol. Polysorbate 80, Sodium carboxymethylcellulose and Sodium chloride)
- •13.Contraindications to use of local anaesthetic: Complete heart block and hypovolaemia
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