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.
ConditionOsteoarthritis of the Knee
InterventionOther: Neuromuscular training (NEMEX-TJR)
Behavioral: Information
Drug: Paracetamol
Drug: Burana
Drug: Pantoprazole
Behavioral: Dietary counseling
Behavioral: Patient education
Other: Insoles
PhaseN/A
SponsorNorthern Orthopaedic Division, Denmark
Responsible PartyNorthern Orthopaedic Division, Denmark
ClinicalTrials.gov IdentifierNCT01535001
First ReceivedFebruary 9, 2012
Last UpdatedApril 22, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateFebruary 9, 2012
Last Updated DateApril 22, 2014
Start DateFebruary 2012
Estimated Primary Completion DateSeptember 2014
Current Primary Outcome MeasuresChange 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
  • Change from baseline in EQ-5D [Time Frame: Primary: 12months. Other: 3, 6 and 24 months] [Designated as safety issue: No]
  • Change from baseline in pain on Visual Analogue Scale (VAS) [Time Frame: Primary: 12months. Other: 3, 6 and 24 months] [Designated as safety issue: No]
  • Change from baseline in 20-meter walk [Time Frame: Primary: 12months. Other: 3, 6 and 24 months] [Designated as safety issue: No]
  • Change from baseline in Isometric Muscle Strength [Time Frame: Primary: 12months. Other: 3, 6 and 24 months] [Designated as safety issue: No]Knee extension and knee flexion measured in sitting position using a handheld dynamometer.
  • Change from baseline in Pain [Time Frame: Primary: 12months. Other: 3, 6 and 24 months] [Designated as safety issue: No]Pain measured at 4 sites in relation to the knee, and 1 control site at m. tibialis anterior using a handheld pressure algometer.
  • Change from baseline in Self-efficacy [Time Frame: Primary: 12months. Other: 3, 6 and 24 months] [Designated as safety issue: No]Self-efficacy on a 100mm VAS in relation to pain, function and quality of life
  • Change from baseline in Postural control and balance [Time Frame: Primary: 12months. Other: 3, 6 and 24 months] [Designated as safety issue: No]Postural control and balance measured standing on a force platform in the following conditions: Eyes open, Eyes closed, Eyes open on foam, Eyes closed on foam.

Descriptive Information[ + expand ][ + ]

Brief TitleStructured Non-operative Treatment of Knee Osteoarthritis
Official TitleStructured 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 TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
ConditionOsteoarthritis of the Knee
InterventionOther: 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)
  • Active Comparator: MEDIC
    Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
  • Active Comparator: Standard treatment
    Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment100
Estimated Completion DateSeptember 2014
Estimated Primary Completion DateSeptember 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesDenmark

Administrative Information[ + expand ][ + ]

NCT Number NCT01535001
Other Study ID NumbersN-20110085
Has Data Monitoring CommitteeNo
Information Provided ByNorthern Orthopaedic Division, Denmark
Study SponsorNorthern Orthopaedic Division, Denmark
CollaboratorsThe 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 DateApril 2014

Locations[ + expand ][ + ]

Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital
Aalborg, Denmark, 9000
Farsoe Hospital
Farsø, Denmark, 9640
Vendsyssel Hospital, Frederikshavn
Frederikshavn, Denmark, 9900