Structured Non-operative Treatment of Knee Osteoarthritis

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.

Conditions

• Osteoarthritis of the Knee

Interventions

OTHER

Neuromuscular training (NEMEX-TJR)

60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.

BEHAVIORAL

Information

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.

DRUG

Paracetamol

1 g x 4/day

DRUG

Burana

400 mg x 3/day for three weeks

DRUG

Pantoprazole

20mg x 1/day for three weeks

BEHAVIORAL

Dietary counseling

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.

BEHAVIORAL

Patient education

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.

OTHER

Insoles

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.

Sponsors & Collaborators

• The Danish Rheumatism Association

  collaborator OTHER

• Association of Danish Physiotherapists

  collaborator OTHER

• Northern Orthopaedic Division, Denmark

  lead OTHER

Principal Investigators

• Søren T. Skou, PhD-student · Orthopaedic Research Unit, Aalborg University Hospital, Denmark

• Ewa M. Roos, PhD · Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark

• Lars Arendt-Nielsen, Dr.Sci.Med. · Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University

• Mogens B. Laursen, PhD · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

• Sten Rasmussen, M.D. · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

• Michael S. Rathleff, PhD-student · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

• Ole H. Simonsen, Dr.Sci.Med. · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• Denmark

Study Locations