Exercise and Steroid in Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intraarticular steroid + Exercise

Intra-articular corticosteroid treatment with subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection

Group Type EXPERIMENTAL

Intraarticular steroid

Intervention Type DRUG

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

Exercise therapy

Intervention Type 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.

Intraarticular saline+Exercise

Combined intra-articular saline injection and subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection

Group Type ACTIVE_COMPARATOR

Intraarticular saline

Intervention Type DRUG

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

Exercise therapy

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Intraarticular saline

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

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No