Exercise and Steroid in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945749
• Other study ID #: 101.04
• Secondary ID: 2012-002607-18
• Status: Completed
• Phase: N/A
• First received: September 16, 2013
• Last updated: May 5, 2014
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee pain	Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire	Change from baseline to week 14	No
Secondary	Knee pain	Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire	Change from baseline to week 2 and week 26	No
Secondary	Knee symptoms	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	Change from baseline to week 2, 14, and 26	No
Secondary	Functional pain test	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.	Change from baseline to week 14, and 26	No
Secondary	Knee Muscle strength	Assessed by an isokinetic dynamometer	Change from baseline to week 14, and 26	No
Secondary	6 minute walk distance	The distance covered during 6 minutes of fast walking	Change from baseline to week 14, and 26	No
Secondary	Systemic markers of inflammation in blood	Blood sample	Change from baseline to week 14, and 26	No
Secondary	MRI based inflammation	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	Change from baseline to week 14, and 26	No