Structured Non-operative Treatment of Knee Osteoarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Danish Rheumatism Association
Association of Danish Physiotherapists
Information provided by (Responsible Party):
Søren Thorgaard Skou, Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01535001
First received: February 9, 2012
Last updated: June 17, 2014
Last verified: June 2014
  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.


Condition Intervention
Osteoarthritis of the Knee
Other: Neuromuscular training (NEMEX-TJR)
Behavioral: Information
Drug: Paracetamol
Drug: Burana
Drug: Pantoprazole
Behavioral: Dietary counseling
Behavioral: Patient education
Other: Insoles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

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 a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.



Secondary Outcome Measures:
  • Change from baseline in EQ-5D [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
    Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint.

  • 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 and 1 control site on the m. extensor carpi radialis longus 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.

  • The five subscales of KOOS [ Time Frame: Primary: 12 months. Other 3, 6 and 24 months ] [ Designated as safety issue: No ]
  • Weight change in percent [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
    Weight change in percent measured without shoes at the same time of day and on the same scale

  • Usage of pain killers (yes/no), number of daily paracetamols (1g) and ibuprofen (400mg) and other NSAIDs. [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
    Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants.

  • Number of sites with pain in the previous 24 hours shaded on a region-divided body chart [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
  • Pain location and type assessed using the reliable interviewer-administered questionnaire Knee Pain Map [ Time Frame: Primary: 12months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]
  • Time from the Timed Up and Go [ Time Frame: Primary: 12 months. Other: 3, 6 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MEDIC
Medicine, Exercise, Diet, Insole and Cognitive/patient education (MEDIC) for three months.
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 Name: No other
Drug: Paracetamol
1 g x 4/day
Other Name: No other
Drug: Burana
400 mg x 3/day for three weeks
Other Name: No other
Drug: Pantoprazole
20mg x 1/day for three weeks
Other Name: No other
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.
Other Name: No other
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 Name: No other
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.

Other Name: No other
Active Comparator: Standard treatment
Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
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.

Other Name: No other

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535001

Locations
Denmark
Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital
Aalborg, Denmark, 9000
Farsoe Hospital
Farsø, Denmark, 9640
Vendsyssel Hospital, Frederikshavn
Frederikshavn, Denmark, 9900
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
The Danish Rheumatism Association
Association of Danish Physiotherapists
Investigators
Principal Investigator: Søren T. Skou, PhD-student Orthopaedic Research Unit, Aalborg University Hospital, Denmark
Study Chair: Ewa M. Roos, PhD Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark
Study Chair: Lars Arendt-Nielsen, Dr.Sci.Med. Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University
Study Chair: Mogens B. Laursen, PhD Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Study Chair: Sten Rasmussen, M.D. Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Study Chair: Michael S. Rathleff, PhD-student Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Study Chair: Ole H. Simonsen, Dr.Sci.Med. Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
  More Information

Publications:

Responsible Party: Søren Thorgaard Skou, Research Physiotherapist, Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01535001     History of Changes
Other Study ID Numbers: N-20110085
Study First Received: February 9, 2012
Last Updated: June 17, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Osteoarthritis, Knee
Treatment Outcome
Time Factors
Rehabilitation
Combined Modality Therapy
Middle Aged
Aged
Aged, 80 and over
Male
Female
Humans
Analysis of Variance

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Pantoprazole
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 29, 2014