Exercise and Steroid in Knee Osteoarthritis

NCT01945749 | Completed DMC

• 2 other identifiers: 101.042012-002607-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Knee pain

  Change from baseline to week 2 and week 26

• Knee symptoms

  Change from baseline to week 2, 14, and 26

• Functional pain test

  Change from baseline to week 14, and 26

• Knee Muscle strength

  Change from baseline to week 14, and 26

• 6 minute walk distance

  Change from baseline to week 14, and 26

Study Arms (2)

Intraarticular steroid + Exercise

EXPERIMENTAL

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

Drug: Intraarticular steroid; Other: Exercise therapy

Intraarticular saline+Exercise

ACTIVE COMPARATOR

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

Drug: Intraarticular saline; Other: Exercise therapy

Interventions

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 steroid + Exercise

Intraarticular saline DRUG

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

Intraarticular saline+Exercise

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.

Intraarticular saline+Exercise; Intraarticular steroid + Exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

Related Publications (3)

• Dall CH, Andersen H, Povlsen TM, Henriksen M. Evaluation of a technology assisted physical activity intervention among hospitalised patients: A randomised study. Eur J Intern Med. 2019 Nov;69:50-56. doi: 10.1016/j.ejim.2019.08.019. Epub 2019 Sep 4.

  PMID: 31494019 DERIVED

• Bartholdy C, Klokker L, Bandak E, Bliddal H, Henriksen M. A Standardized "Rescue" Exercise Program for Symptomatic Flare-up of Knee Osteoarthritis: Description and Safety Considerations. J Orthop Sports Phys Ther. 2016 Nov;46(11):942-946. doi: 10.2519/jospt.2016.6908. Epub 2016 Sep 28.

  PMID: 27681448 DERIVED

• Henriksen M, Christensen R, Klokker L, Bartholdy C, Bandak E, Ellegaard K, Boesen MP, Riis RG, Bartels EM, Bliddal H. Evaluation of the benefit of corticosteroid injection before exercise therapy in patients with osteoarthritis of the knee: a randomized clinical trial. JAMA Intern Med. 2015 Jun;175(6):923-30. doi: 10.1001/jamainternmed.2015.0461.

  PMID: 25822572 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Marius Henriksen, PhD

  Frederiksberg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 19, 2013
• Study Start: October 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

DK (1)