ISRCTN28555470
Active, not recruiting
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Knee osteoarthritis (symptomatic)
- Sponsor
- Keele University
- Enrollment
- 466
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33771832/ (added 13/08/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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