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Exercise and Steroid in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intraarticular steroid
Intraarticular saline
Exercise therapy
Sponsored by
Frederiksberg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Parker Institute, Frederiksberg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intraarticular steroid + Exercise

Intraarticular saline+Exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

Knee pain
Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire

Secondary Outcome Measures

Knee pain
Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
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
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.
Knee Muscle strength
Assessed by an isokinetic dynamometer
6 minute walk distance
The distance covered during 6 minutes of fast walking
Systemic markers of inflammation in blood
Blood sample
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

Full Information

First Posted
September 16, 2013
Last Updated
May 5, 2014
Sponsor
Frederiksberg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01945749
Brief Title
Exercise and Steroid in Knee Osteoarthritis
Official Title
Combined Intra Articular Corticosteroid and Physiotherapeutic Exercise in Patients With Osteoarthritis of the Knee: A Random-ised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Frederiksberg University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraarticular steroid + Exercise
Arm Type
Experimental
Arm Description
Intra-articular corticosteroid treatment with subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
Arm Title
Intraarticular saline+Exercise
Arm Type
Active Comparator
Arm Description
Combined intra-articular saline injection and subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
Intervention Type
Drug
Intervention Name(s)
Intraarticular steroid
Intervention Description
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
Intervention Name(s)
Intraarticular saline
Intervention Description
1 ml isotonic saline mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
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 Outcome Measure Information:
Title
Knee pain
Description
Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time Frame
Change from baseline to week 14
Secondary Outcome Measure Information:
Title
Knee pain
Description
Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time Frame
Change from baseline to week 2 and week 26
Title
Knee symptoms
Description
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
Time Frame
Change from baseline to week 2, 14, and 26
Title
Functional pain test
Description
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.
Time Frame
Change from baseline to week 14, and 26
Title
Knee Muscle strength
Description
Assessed by an isokinetic dynamometer
Time Frame
Change from baseline to week 14, and 26
Title
6 minute walk distance
Description
The distance covered during 6 minutes of fast walking
Time Frame
Change from baseline to week 14, and 26
Title
Systemic markers of inflammation in blood
Description
Blood sample
Time Frame
Change from baseline to week 14, and 26
Title
MRI based inflammation
Description
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
Time Frame
Change from baseline to week 14, and 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Henriksen, PhD
Organizational Affiliation
Frederiksberg University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Parker Institute, Frederiksberg Hospital
City
Copenhagen
ZIP/Postal Code
2000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31494019
Citation
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.
Results Reference
derived
PubMed Identifier
27681448
Citation
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.
Results Reference
derived
PubMed Identifier
25822572
Citation
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.
Results Reference
derived

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Exercise and Steroid in Knee Osteoarthritis

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