Knee Osteoarthritis MedDRA version: 14.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Depo-medrol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: METHYLPREDNISOLONE ACETATE
CAS Number: 53-36-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Marius Henriksen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in - Pain subscale on the Knee Osteoarthritis Outcome Score (KOOS) questionnaire at week 2 and 26 - KOOS questionnaire subscales: Symptoms, Physical function, Quality of life, and Participation in sports and recreation at week 2, 14 and 26 - ADL-Q quesationnaire (function during activities of daily living) at week 2, 14 and 26 - PainDetect questionnaire (neuropathic pain) at week 2, 14 and 26 - Functional pain test at week 14 and 26 - Pain sensitivity at week 14 and 26 - Inflammatory markers in blood, urine and joint fluids at week 14 and 26 - Imaging markers of inflammation (ultrasound and MRI) at week 14 and 26 - Biomechanical gait analysis at week 14 and 26 - Isometric muscle strength at week 14 and 26 - Six-minute walk test at week 14 and 26;Timepoint(s) of evaluation of this end point: week 2 (only questionnaires) week 14 and 26 | — |
Countries
Denmark
Contacts
Public ContactThe Parker Institute
The Parker Institute
Outcome results
None listed