Structured Non-operative Treatment of Knee Osteoarthritis
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Osteoarthritis of the Knee |
Intervention | Other: Neuromuscular training (NEMEX-TJR) Behavioral: Information Drug: Paracetamol Drug: Burana Drug: Pantoprazole Behavioral: Dietary counseling Behavioral: Patient education Other: Insoles |
Phase | N/A |
Sponsor | Northern Orthopaedic Division, Denmark |
Responsible Party | Northern Orthopaedic Division, Denmark |
ClinicalTrials.gov Identifier | NCT01535001 |
First Received | February 9, 2012 |
Last Updated | April 22, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 9, 2012 |
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Last Updated Date | April 22, 2014 |
Start Date | February 2012 |
Estimated Primary Completion Date | September 2014 |
Current Primary Outcome Measures | Change from baseline in KOOS4 (Knee injury and Osteoarthritis Outcome Score) [Time Frame: Primary: 12months. Other: 3, 6 and 24 months.] [Designated as safety issue: No]The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using ANCOVA adjusting for baseline values. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Structured Non-operative Treatment of Knee Osteoarthritis |
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Official Title | Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up |
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. |
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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment |
Condition | Osteoarthritis of the Knee |
Intervention | 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. Other Names: No otherBehavioral: 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. Other Names: No otherDrug: Paracetamol 1 g x 4/day Other Names: No otherDrug: Burana 400 mg x 3/day for three weeks Other Names: No otherDrug: Pantoprazole 20mg x 1/day for three weeks Other Names: No otherBehavioral: 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. Other Names: No otherBehavioral: 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 Names: No otherOther: 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. Other Names: No other |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 100 |
Estimated Completion Date | September 2014 |
Estimated Primary Completion Date | September 2014 |
Eligibility Criteria | Inclusion Criteria: - Knee-OA detected by x-ray (Kellgren & Lawrence grade 1 or greater) - KOOS4 of ≤ 75 - Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon. - The participant is > 18 years of age. - The participant can provide relevant and adequate, informed consent. Exclusion Criteria: - Prior TKA ipsilateral - Rheumatoid arthritis - Mean VAS > 60mm the last week on a 0-100mm scale - Possible pregnancy or planning pregnancy; - Inability to comply with the protocol; - Inadequacy in written and spoken Danish. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01535001 |
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Other Study ID Numbers | N-20110085 |
Has Data Monitoring Committee | No |
Information Provided By | Northern Orthopaedic Division, Denmark |
Study Sponsor | Northern Orthopaedic Division, Denmark |
Collaborators | The Danish Rheumatism Association The Association of Danish Physiotherapists Research Fund |
Investigators | Principal Investigator: Søren T. Skou, PhD-student Orthopaedic Research Unit, Aalborg University Hospital, DenmarkStudy Chair: Ewa M. Roos, PhD Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, DenmarkStudy Chair: Lars Arendt-Nielsen, Dr.Sci.Med. Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg UniversityStudy Chair: Mogens B. Laursen, PhD Orthopaedic Surgery Research Unit, Aalborg University Hospital, DenmarkStudy Chair: Sten Rasmussen, M.D. Orthopaedic Surgery Research Unit, Aalborg University Hospital, DenmarkStudy Chair: Michael S. Rathleff, PhD-student Orthopaedic Surgery Research Unit, Aalborg University Hospital, DenmarkStudy Chair: Ole H. Simonsen, Dr.Sci.Med. Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital | Aalborg, Denmark, 9000 |
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Farsoe Hospital | Farsø, Denmark, 9640 |
Vendsyssel Hospital, Frederikshavn | Frederikshavn, Denmark, 9900 |