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Completed

NCT Number: NCT01945749

Exercise and Steroid in Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraarticular steroid

Drug

1 ml methylprednisolon corticosteroid (40 mg Depo-Medrol®) mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided.

Intraarticular saline

Drug

1 ml isotonic saline mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided

Exercise therapy

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Registry information

Official study title

Combined Intra Articular Corticosteroid and Physiotherapeutic Exercise in Patients With Osteoarthritis of the Knee: A Random-ised Clinical Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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