Exercise and Pain Sensitivity in Knee Osteoarthritis

Study Overview
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Brief Summary
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A commonly administered conservative non-pharmacological treatment for OA is exercise, with beneficial effects in terms of reduced pain and disability. While the link between exercise and reduced disability is mediated by e.g. increased muscle strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA patients have both peripheral and central sensitization of pain mechanisms resulting in hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral and central mechanisms but it unknown if exercise affects either of these mechanisms. It is hypothesized that in knee OA patients exercise reduces the pain sensitivity

Official Title
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Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 40 years Clinical diagnosis of tibiofemoral osteoarthritis Radiographic verification of diagnosis (Kellgren&Lawrence 2 or 3) Ability to participate in examinations Ability to participate in exercise sessions 20≤ Body Mass Index (BMI) ≤35 kg/m2 Ability to comply with rules about concomitant medication and therapy Speak, read and write Danish Exclusion Criteria: Participation in exercise training for the knee osteoarthritis within 3 months of enrollment Counterindications for exercise Pregnant or breastfeeding Current or previous autoimmune disease History of surgical joint replacement in the lower limbs Planned surgery Current or previous diagnosis or signs of cardiovascular disease Neurological disorders Alcohol or drug abuse Diabetes Psychiatric disorders Regional pain syndromes Regional pain caused by lumbar or cervical nerve root compression Counterindications to MR scan Counterindications to MR contrast

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise training supervised by trained physiotherapists lasting 60 minutes performed 3 times/week. | Other: Exercise<br>* Physiotherapy supervised exercise training. 60 minutes 3 times per week<br>* Other names: Exercise training;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mechanical pain sensitivity | Pain thresholds and temporal summation of pain | Baseline and at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine |  | Baseline and at 12 weeks | 
| Change from baseline in patient reported pain and function | KOOS questionnaire | Baseline and at 12 weeks | 
| Change from baseline in functional pain test | Pain is assessed during continuous tradmill walking at self-selected pace for 20 minutes. | Baseline and at 12 weeks | 
| Change from baseline in imaged based quantification of inflammation in the knee | Contrast enhanced MRI imaging used to quantify inflammation (DYNAMICA software) | Baseline and at 12 weeks |