ISRCTN28555470进行中（未招募）未知
A multi-centre, primary care, randomised, parallel-group, superiority trial (with internal pilot) to evaluate the effectiveness of bracing in the management of symptomatic knee osteoarthritis: the PROP OA trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 466
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33771832/ (added 13/08/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/05/2021:
- •1. Aged 45 years and over
- •2. Residing in England
- •3. Clinically significant knee pain on weight bearing (NRS >=4)
- •4. With or without knee instability or buckling
- •5. Able to have knee x-ray
- •6. Able to read and write English
- •7. Access to a mobile phone that can receive SMS text messages
- •8. Able to give full informed consent
- •9. Willing to participate
- •Previous inclusion criteria:
- •1. Aged 45 years and over
- •2. Residing in England
- •3. Clinically significant knee pain on weight bearing (NRS >=4)
- •4. With or without knee instability or buckling
- •5. No morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
- •6. Able to have knee x-ray
- •7. Able to read and write English
- •8. Access to a mobile phone that can receive SMS text messages
- •9. Able to give full informed consent
- •10. Willing to participate
排除标准
- •Current inclusion criteria as of 14/05/2021:
- •1. Red flags in the history or clinical examination that may indicate further investigation or referral for possible serious underlying pathology
- •2. Vulnerable individuals (e.g. in palliative phase of care for cancer, unstable mental health disorders)
- •3. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis)
- •4. Symptoms not attributable to knee osteoarthritis
- •5. Previous total knee replacement, high tibial osteotomy, or autologous cartilage implantation
- •6. On the waiting list for TKR/THR within the next 6 months
- •7. Unwilling to wear a knee brace
- •8. Brace size unavailable for leg circumference
- •9. Knee brace contraindicated (superficial wounds where the knee brace would reside, psoriasis, eczema or poor circulation, arterial insufficiency, or severe varicosities that could result in skin at risk with regular brace wear, a history of thrombophlebitis in either leg)
- •10. Recent/routine knee brace wear within the last 3 months
- •11. Nursing home resident
- •12. Unable to attend clinic
- •13. Close family member already a trial participant
- •14. Knee injection in the last 3 months
- •15. Course of physiotherapy in the last 3 months
- •16. Significant neurological disorder (e.g. stroke, Parkinson’s disease, multiple sclerosis, dementia)
- •17. Fibromyalgia
- •18. Autologous cartilage implantation in last 12 months in the knee to be treated
- •19. Significant fixed flexion deformity that prevents fitting of brace
- •Previous exclusion criteria:
- •1. Red flags in the history or clinical examination that may indicate further investigation or referral for possible serious underlying pathology
- •2. Vulnerable individuals (e.g. in palliative phase of care for cancer, unstable mental health disorders)
- •3. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis)
- •4. Symptoms not attributable to knee osteoarthritis
- •5. Previous total knee replacement, high tibial osteotomy, or autologous cartilage implantation
- •6. On the waiting list for TKR/THR within the next 6 months
- •7. Unwilling to wear a knee brace
- •8. Brace size unavailable for leg circumference
- •9. Knee brace contraindicated (superficial wounds where the knee brace would reside, psoriasis, eczema or poor circulation, arterial insufficiency, or severe varicosities that could result in skin at risk with regular brace wear, a history of thrombophlebitis in either leg)
- •10. Recent/routine knee brace wear within the last 3 months
- •11. Nursing home resident
- •12. Unable to attend clinic
- •13. Close family member already a trial participant
- •14. Knee injection in the last 3 months
- •15. Course of physiotherapy in the last 3 months
研究者
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