COMBINED INTRA ARTICULAR CORTICOSTEROID AND EXERCISE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE: A RANDOMISED TRIA

Phase 1

Conditions: Knee Osteoarthritis
MedDRA version: 14.1Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2012-002607-18-DK

Lead Sponsor: Marius Henriksen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Age above 40 years
- Diagnosed knee osteoarthritis (diagnostic criteria)
- Radiolographic verification of the diagnosis
- Knee pain of at least 40 mm on a 0-100 mm visual analog scale
- Clinical signs of localised inflammation in the knee
- 20= Body Mass Index (BMI) =35 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Participation in physiotherapy exercise program within 3 months
- Counterindications to exercise
- Counterindications to glucocorticosteroid
- Current or previous signs of autoimmune disease
- Planned surgery during the study period
- Significant cardiovascular disease
- Chronic Obstructive Pulmonary Disease
- Significant neurological disease
- Alcohol or narcotics abuse within last 5 years
- Current or previous psychiatric diagnosis
- Regional pain syndroms (e.g fibromyalgia)
- Regional pain caused by nerve root compression
- Any other condition that in the oppinion of the investigator will represent an unnecessary risk for the potential participant

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of phsyiotherapeutic exercise in combination with pharmacological antiinflammatory treatment on patient reported pain in patients with knee osteoarthritis.;Secondary Objective: To investigate possible mechanisms behind the effect;Primary end point(s): Change from baseline in self reported pain assessed by the pain subscale on the Knee Osteoarthritis Outcome Score (KOOS) questionnaire.;Timepoint(s) of evaluation of this end point: After 14 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline in <br>- Pain subscale on the Knee Osteoarthritis Outcome Score (KOOS) questionnaire at week 2 and 26<br>- KOOS questionnaire subscales: Symptoms, Physical function, Quality of life, and Participation in sports and recreation at week 2, 14 and 26 <br>- ADL-Q quesationnaire (function during activities of daily living) at week 2, 14 and 26<br>- PainDetect questionnaire (neuropathic pain) at week 2, 14 and 26<br>- Functional pain test at week 14 and 26<br>- Pain sensitivity at week 14 and 26<br>- Inflammatory markers in blood, urine and joint fluids at week 14 and 26<br>- Imaging markers of inflammation (ultrasound and MRI) at week 14 and 26<br>- Biomechanical gait analysis at week 14 and 26<br>- Isometric muscle strength at week 14 and 26<br>- Six-minute walk test at week 14 and 26;Timepoint(s) of evaluation of this end point: week 2 (only questionnaires)<br>week 14 and 26