Effect of lateral wedge insoles on osteoarthritis knee pain and joint loading
- Conditions
- Osteoarthritis of the kneeMusculoskeletal DiseasesPolyarthrosis, unspecified
- Registration Number
- ISRCTN67577681
- Lead Sponsor
- niversity of Salford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 42
1. Aged 40 to 85 years
2. Pain with walking (using KOOS question (P5), they need to have at least mild pain walking on a flat surface)
3. On anteroposterior (AP) or Posterior-Anterior (PA) view x-ray (weight bearing, if possible) within the last 2 years of screening. They need to have definite medial narrowing and not lateral narrowing and evidence (osteophyte + or definite sclerosis) of OA (this would give them Kellgren and Lawrence grade 2 or 3 with medial narrowing). And the absence of patellofemoral osteoarthritis on x-ray (must be less severe OA that medial disease and cannot be KL3 or higher in patellofemoral joint). Therefore for a patient to be eligible on x-ray they must fulfil the following criteria:
3.1. KL grade 2 or 3 in the tibiofemoral joint (TFJ)
3.2. The KL grade in the TFJ must be higher than the PFJ and cannot be equal
3.3. The medial joint space narrowing score must be higher that the lateral joint space narrowing score and cannot be equal
3.4. Medial tenderness either by their own indication that this is where they have pain or by examination showing tenderness at the medial TF joint line ? Clinical diagnosis by qualified clinician. Absence of of PF tenderness on examination
3.5. They are able to walk for 100 metres non-stop
Target Gender: Male & Female; Upper Age Limit 85 years ; Lower Age Limit 40 years
Participants will be excluded if the pain is more localised to the patellofemoral joint on examination than medial joint line, have tricompartmental knee osteoarthritis or have grade 4 medial tibiofemoral osteoarthritis on the Kellgren Lawrence scale.
Other exclusions include:
1. A history of high tibial osteotomy or other realignment surgery or total knee replacement on the affected side
2. Knee Arthroscopy with the last 6 months
3. Intraarticular injection into the treatment knee in the last 3 months
4. Inflammatory arthritis including Rheumatoid Arthritis
5. Complex pain conditions such as Diabetic Neuropathic pain, fibromyalgia
6. Any foot and ankle problems that will contraindicate the use of the footwear load modifying interventions.
7. Severe coexisting medical morbidities
8. Use, or have used, orthoses of any description prescribed by a Podiatrist or Orthotist within the last 2 months.
9. Cannot understand procedures
10. Body Mass Index (BMI) >35 since gait laboratory cannot perform accurate measurements
11. Unable to walk unaided and have to rely on a stick, crutch or frame
12. If the participants cannot walk for 100 metres without stopping they will also be excluded, as they may be unable to complete the full testing protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale, measured at baseline, weeks 3, 6, 10, 13 and 16
- Secondary Outcome Measures
Name Time Method <br> 1. Comfort rating scale, measured at baseline, weeks 3, 6, 13 and 16<br> 2. External adduction moment, measured at 2 weeks (evaluation of responder/non-responder status), 6 weeks and 16 weeks<br> 3. Patient perceived global change in pain, measured at baseline, week 6, 10 and 16<br>