F K Nielsen1, M Boesen2, A G Jurik3, H Bliddal4, J D Nybing5, K Ellegaard6, C Bartholdy7, E Bandak8, M Henriksen9. 1. Department of Radiology, Aarhus University Hospital, Noerrebrogade 44, 8000 Aarhus, Denmark; The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark. Electronic address: flemming.kromann@aarhus.rm.dk. 2. Department of Radiology, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark. Electronic address: mikael.ploug.boesen@regionh.dk. 3. Department of Radiology, Aarhus University Hospital, Noerrebrogade 44, 8000 Aarhus, Denmark; Institute of Clinical Medicine, Aarhus University, Denmark. Electronic address: annejuri@rm.dk. 4. The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark. Electronic address: henning.bliddal@regionh.dk. 5. Department of Radiology, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark. Electronic address: janus.damm.nybing@regionh.dk. 6. The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark. Electronic address: karen.ellegaard@regionh.dk. 7. The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark; The Department of Physical and Occupational Therapy, Copenhagen University Hospital Bispebjerg-Frederiksberg, Bispebjerg Bakke 23, 2400 København NV, Denmark. Electronic address: cecilie.roedgaard.bartholdy@regionh.dk. 8. The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark. Electronic address: elisabeth.ann.bandak@regionh.dk. 9. The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark; The Department of Physical and Occupational Therapy, Copenhagen University Hospital Bispebjerg-Frederiksberg, Bispebjerg Bakke 23, 2400 København NV, Denmark. Electronic address: marius.henriksen@regionh.dk.
Abstract
OBJECTIVE: To evaluate if the relative volume of bone marrow lesions (BMLs) changed in patients with knee osteoarthritis (OA) during a therapeutic study. DESIGN: This study is a sub-study to a larger clinical trial which compared the clinical effects of intra-articular corticosteroid injection in knee OA to placebo injection, both given prior to exercise therapy. Clinical assessment using the Knee injury and Osteoarthritis Outcome Score (KOOS) and magnetic resonance imaging (MRI) examinations with BML assessments were performed at baseline and follow-up after 14 weeks and 26 weeks, respectively. The BML volume was determined using a computer assisted method focusing on participants with valid baseline and follow-up MRI examinations. Any changes in BML and KOOS were analyzed and investigated for associations. RESULTS: Fifty participants received steroid and placebo injection, respectively, of which 41 and 45 had complete MRI examinations at week 14, and 36 and 33 at week 26, respectively. All participants received 12 weeks of exercise. A significant change in relative BML volume was observed between the corticosteroid group and the placebo group after 14 weeks [-1.1% vs 2.7%; between-group difference, 3.8% (95% CI 0.5-7.0)] but not after 26 weeks [0.8% vs 1.6%; between-group difference, 0.8% (95% CI -2.8 to 4.4)]. No significant association was found between changes in relative BML volume and KOOS. CONCLUSIONS: Despite the statistically significant difference in BML volume at 14 weeks after corticosteroid injection and 12 weeks exercise therapy compared to placebo injection and exercise, there is very little evidence on a relationship between corticosteroids and BML volume. EU CLINICAL TRIALS REGISTER: EudraCT number: 2012-002607-18.
RCT Entities:
OBJECTIVE: To evaluate if the relative volume of bone marrow lesions (BMLs) changed in patients with knee osteoarthritis (OA) during a therapeutic study. DESIGN: This study is a sub-study to a larger clinical trial which compared the clinical effects of intra-articular corticosteroid injection in knee OA to placebo injection, both given prior to exercise therapy. Clinical assessment using the Knee injury and Osteoarthritis Outcome Score (KOOS) and magnetic resonance imaging (MRI) examinations with BML assessments were performed at baseline and follow-up after 14 weeks and 26 weeks, respectively. The BML volume was determined using a computer assisted method focusing on participants with valid baseline and follow-up MRI examinations. Any changes in BML and KOOS were analyzed and investigated for associations. RESULTS: Fifty participants received steroid and placebo injection, respectively, of which 41 and 45 had complete MRI examinations at week 14, and 36 and 33 at week 26, respectively. All participants received 12 weeks of exercise. A significant change in relative BML volume was observed between the corticosteroid group and the placebo group after 14 weeks [-1.1% vs 2.7%; between-group difference, 3.8% (95% CI 0.5-7.0)] but not after 26 weeks [0.8% vs 1.6%; between-group difference, 0.8% (95% CI -2.8 to 4.4)]. No significant association was found between changes in relative BML volume and KOOS. CONCLUSIONS: Despite the statistically significant difference in BML volume at 14 weeks after corticosteroid injection and 12 weeks exercise therapy compared to placebo injection and exercise, there is very little evidence on a relationship between corticosteroids and BML volume. EU CLINICAL TRIALS REGISTER: EudraCT number: 2012-002607-18.