Topic: Primary Care, Musculoskeletal disorders
Conditions
Interventions
1. Lateral Wedge: Participants will be required to wear a lateral wedge in their shoes for a period of 8 weeks
2. Placebo: Participants will be asked to wear a neutral insole for a period of 8 weeks
F
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion 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
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) 11. Currently use, or have used, orthoses of any description prescribed by a Podiatrist or Orthotist within the last 2 months. 12. Unable to take in, understand or retain the information provided regarding the study procedures. 13. Inability to walk for 100 metres without stopping, as they may be unable to complete the full testing protocol. 14. Contraindication to MRI such as, but not limited to:Metal implants which prohibit safe use of MRI scan including cochlear implants / metal objects in the body including, knee prosthesis , cardiac or neural pacemakers, hydrocephalus shunts, intrauterine device or coil, claustrophobia, inability to lie in the MRI for up to 1 hour. 15. Planned surgery or knee replacement in next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee pain using Numerical Rating Scale – Last Week (Patient perceived Pain/Discomfort overall in the last week) question. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Structural end point: volume of BMLs in the medial TF compartment on MRIs 2. Other measures of knee pain: pain on nominated activity using NRSNA : Numerical Rating Scale - Nominated Activity (patient nominated aggravating activity causing most pain) and KOOS pain and other subscales; physical activity over 1 week (based on activity monitoring); rescue analgesia 3. Physical function: KOOS subscales and SF12 4. Structural outcomes: BMLs in the whole knee | — |
Countries
England, United Kingdom
Outcome results
None listed