ISRCTN55059760
Completed
未知
The effect of lateral wedge INsoles on pain in individuals with medial knee osteoarthritis who biomechanically RESPOND
niversity of Manchester0 sites83 target enrollmentApril 2, 2015
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Primary Care, Musculoskeletal disorders
- Sponsor
- niversity of Manchester
- Enrollment
- 83
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30615299 results 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/36474674/ Secondary analysis (added 17/05/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 40\-85
- •2\. Global pain based on NRS \= 4
- •3\. Kellgren and Lawrence grades 2 – 4 on AP or PA view xray
- •(weight bearing, if possible) within the last 2 years of screening. Also, they need to have definite medial narrowing and NOT definite lateral narrowing and evidence (osteophyte \+/or definite sclerosis) of OA. And patellofemoral osteoarthritis on xray must be less severe than medial OA and cannot be KL3 or higher in patellofemoral joint
- •4\. On clinical examination, medial joint line tenderness and without significant tenderness at the medial or lateral patellar facets, nor pain on patellar compression tests (which would indicate predominantly PF joint disease and are exclusion findings)
- •5\. Stable medication regimen for 3 months (e.g. if the patients are using NSAIDs there should be no change)
- •6\. Willing to wear insoles for at least 4 hours per day
Exclusion Criteria
- •1\. Pain is more localised to the patellofemoral joint on examination than medial joint line
- •2\. A history of high tibial osteotomy or other realignment surgery or total knee replacement on the affected side.
- •3\. Knee Arthroscopy within at least 6 months
- •4\. Intraarticular injection or visco supplementation injection into the treatment knee in the last 3 months.
- •5\. Inflammatory arthritis including Rheumatoid Arthritis, psoriatic arthritis
- •6\. Diabetic Neuropathic pain, fibromyalgia
- •7\. Foot and ankle problems that will contraindicate the use of the footwear load modifying interventions.
- •8\. Severe coexisting medical morbidities.
- •9\. Unable to walk unaided and have to rely on a stick, crutch or frame
- •10\. BMI greater than 35 (since the gait laboratory cannot perform accurate measurements and the MRI knee coil may not fit these patients)
Outcomes
Primary Outcomes
Not specified
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