Exercise and Steroid in Knee Osteoarthritis

Frederiksberg University Hospital

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Exercise therapy; Drug: Intraarticular steroid; Drug: Intraarticular saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01945749

101.04

2012-002607-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Intraarticular steroid + Exercise

Experimental group

Description:

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

Treatment:

Other: Exercise therapy

Drug: Intraarticular steroid

Intraarticular saline+Exercise

Active Comparator group

Description:

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

Treatment:

Other: Exercise therapy

Drug: Intraarticular saline