Structured Non-operative Treatment of Knee Osteoarthritis

September 14, 2017 updated by: Northern Orthopaedic Division, Denmark

Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • No other
Drug: Paracetamol
1 g x 4/day
Other Names:
  • No other
Drug: Burana
400 mg x 3/day for three weeks
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • No other
Drug: Pantoprazole
20mg x 1/day for three weeks
Other Names:
  • 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 Names:
  • No other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)
Time Frame: Primary: 12months.

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.
Primary: 12months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change in kg From Baseline
Time Frame: Primary: 12months.
Weight change in kg measured without shoes at the same time of day and on the same scale
Primary: 12months.
Proportion of Users of Pain Medication
Time Frame: Baseline and 12months.
With possible answers being yes and no
Baseline and 12months.
Change From Baseline in EQ-5D
Time Frame: Primary: 12months.

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. See statistical analysis plan for further description (available under "Links").

Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best).
Primary: 12months.
Change From Baseline in 20-meter Walk
Time Frame: Primary: 12months.
Primary: 12months.
Change in the Five KOOS Subscale Scores From Baseline
Time Frame: Primary: 12 months.
Range of all subscales are 0 to 100 (worst to best).
Primary: 12 months.
Number of Serious Adverse Events Reported at Index Knee
Time Frame: Primary: 12months.
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.
Primary: 12months.
Change From Baseline in Time From the Timed Up and Go
Time Frame: Primary: 12 months.
Primary: 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Outcomes
Time Frame: Baseline, 3months, 6months, 12months and 24months
  1. Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.
  2. Number of sites with pain in the previous 24 hours shaded on a region-divided body chart
  3. Pain location and type assessed using the Knee Pain Map.
  4. Maximum isometric muscle strength measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander).
  5. Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II) at five sites at the knee and the m. tibialis anterior muscle and the m. extensor carpi radialis longus.
  6. Postural balance assessed using an instrumented force platform (Good Balance), measuring the centre of pressure excursion.
  7. Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.
Baseline, 3months, 6months, 12months and 24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Association of Danish Physiotherapists
The Danish Rheumatism Association

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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (ESTIMATE)

February 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20110085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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