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Exercise and Steroid in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01945749
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Henning Bliddal, Frederiksberg University Hospital

Study Description
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Brief Summary:

Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and disability. As no cure exists, management aims to reduce pain, improve function, and enhance quality of life. The recommended hierarchy of management should consist of exercise in first line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.

The effect size of exercise therapy is of the same magnitude as most pharmacological treatments but is often without adverse effects. Local pharmacological treatment of the afflicted knee joint is recommended by means of intra-articular injections of corticosteroids, which is considered as a standard medical treatment of knee OA and are included in established guidelines for management of knee OA. While the two treatment approaches have been investigated separately in numerous clinical trials, the efficacy of a combined pharmacological and non-pharmacological approach is not known, despite the high rank of such combined treatment approach on the recommended hierarchy of management.

The purpose of this study is to assess the effects of exercise therapy in combination with intra-articular corticosteroid injections on patient reported pain and function in patients with knee OA.

The hypothesis is that the combined treatment approach (exercise therapy preceded by intra-articular injection of corticosteroid) enhances the clinical outcome compared to exercise therapy preceded by a placebo injection.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Intraarticular steroid Drug: Intraarticular saline Other: Exercise therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Intra Articular Corticosteroid and Physiotherapeutic Exercise in Patients With Osteoarthritis of the Knee: A Random-ised Clinical Trial
Study Start Date : October 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intraarticular steroid + Exercise
Intra-articular corticosteroid treatment with subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
 Drug: Intraarticular steroid
1 ml methylprednisolon corticosteroid (40 mg Depo-Medrol®) mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided.

Other: Exercise therapy

The exercise is commenced 2 weeks after injection.

The exercise includes a 10 minute warm up phase (ergometer bicycling) followed by strengthening and coordination exercises focusing on trunk, hip and knees.

In case of pain or symptom exacerbation, a rescue exercise program is administered, excluding weight bearing activities.
Active Comparator: Intraarticular saline+Exercise
Combined intra-articular saline injection and subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
 Drug: Intraarticular saline
1 ml isotonic saline mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided

Other: Exercise therapy

The exercise is commenced 2 weeks after injection.

The exercise includes a 10 minute warm up phase (ergometer bicycling) followed by strengthening and coordination exercises focusing on trunk, hip and knees.

In case of pain or symptom exacerbation, a rescue exercise program is administered, excluding weight bearing activities.


Outcome Measures
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Primary Outcome Measures :
  1. Knee pain [ Time Frame: Change from baseline to week 14 ]
    Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire


Secondary Outcome Measures :
  1. Knee pain [ Time Frame: Change from baseline to week 2 and week 26 ]
    Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

  2. Knee symptoms [ Time Frame: Change from baseline to week 2, 14, and 26 ]
    Self-reported knee symptoms, knee related function, quality of life and, function during sports and recreation assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

  3. Functional pain test [ Time Frame: Change from baseline to week 14, and 26 ]
    Knee OA pain is associated with movement of the afflicted knee. Therefore we assess pain intensity and movement tolerance during repeated squatting. The test has 3 outcomes: 1) The number of pain free squatting movements that can be done in 30 seconds; 2) the number of painful squatting movements that can be done in 30 seconds; and 3) the average pain intensity during the squatting movements assessed on a 0-10 numeric rating scale.

  4. Knee Muscle strength [ Time Frame: Change from baseline to week 14, and 26 ]
    Assessed by an isokinetic dynamometer

  5. 6 minute walk distance [ Time Frame: Change from baseline to week 14, and 26 ]
    The distance covered during 6 minutes of fast walking

  6. Systemic markers of inflammation in blood [ Time Frame: Change from baseline to week 14, and 26 ]
    Blood sample

  7. MRI based inflammation [ Time Frame: Change from baseline to week 14, and 26 ]
    To assess the severity and extent of local inflammation in the knee and surrounding tissues magnetic resonance imaging (MRI) are done before and after intravenous injection of a Gadolinium contrast agent. Contrast agents are only administered to participants with normal kidney function assessed from a standard blood sample


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 40 years or above
  • clinical knee osteoarthritis verified by radiography
  • pain during level walking of at least 40 mm on a 0-100 mm visual analog scale
  • clinical signs of local inflammation
  • body mass index between 20 and 35

Exclusion Criteria:

  • Exercise therapy within 3 months
  • Intraarticular corticosteroid within 3 months
  • Counter indications to exercise
  • Counter indications to corticosteroid
  • pregnant or breast feeding
  • Auto immune disease
  • Planned surgery in the study period
  • significant cardiovascular disease
  • significant neuroloigal disease
  • significant psychiatric disease
  • regional pain syndromes (e.g. fibromyalgia)
  • spinal nerve root compression syndromes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945749


Locations
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Denmark
The Parker Institute, Frederiksberg Hospital
Copenhagen, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
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Study Chair: Marius Henriksen, PhD Frederiksberg University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Henning Bliddal, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01945749    
Other Study ID Numbers: 101.04
2012-002607-18 ( EudraCT Number )
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases