Clinical trial NCT01535001
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, Knee Treatment Outcome Time Factors Rehabilitation Combined Modality Therapy Middle Aged Aged Aged, 80 and over Male Female Humans Analysis of Variance
Sponsor: Northern Orthopaedic Division, Denmark
Start date: 2012-02-01; Completion date: 2014-09-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.

The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment.

See statistical analysis plan available under "Links" for further description of the study.

Detailed description:
Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.

It is recommended both nationally and internationally that the treatment of knee osteoarthritis should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement.

However if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. This postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. Therefore, the current treatment strategy for the patient group is problematic.

The current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.

Arms: arm 1: Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months. arm 2: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
Interventions: intervention 1: Neuromuscular training (NEMEX-TJR) intervention 2: Information intervention 3: Paracetamol intervention 4: Burana intervention 5: Pantoprazole intervention 6: Dietary counseling intervention 7: Patient education intervention 8: Insoles
Intervention descriptions: intervention 1: 60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR. intervention 2: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.

Information will be given in a leaflet. intervention 3: 1 g x 4/day intervention 4: 400 mg x 3/day for three weeks intervention 5: 20mg x 1/day for three weeks intervention 6: For participants with a BMI equal to or \>25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs. intervention 7: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, "Lær at leve med kronisk sygdom (Learn to live with chronic illness)" by The National Board of Health, Denmark and "Artrosskolan Spenshult" in Sweden. intervention 8: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).

The participants will be advised to use the insoles in all shoes.

Protocol documents: