A randomized double-blind placebo-controlled trial investigating pain characteristics in response to diclofenac or placebo in symptomatic knee osteoarthritis.

Conditions

Knee osteoarthritis

Brief summary

Change from baseline to end of study (EoS) in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain between the active and the placebo group with the PRMS.

Detailed description

Change from baseline to EoS in KOOS pain., Change from baseline to EoS in ICOAP constant pain, intermittent pain, and the total ICOAP score., Difference in the observed standard deviation of the change from baseline to EoS in KOOS pain and ICOAP., Changes from baseline to EoS in pressure pain threshold (PPT) at relevant locations, temporal summation of pain (TSP), and conditioned pain modulation (CPM)., Change from baseline to EoS in KOOS function., Change from baseline to EoS in “40-meter walk test”., Change from baseline to EoS in number of placebo responders (≥30% and ≥50%)., Change from baseline to EoS in number of subjects meeting the OMERACT-OARSI responder criteria.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGThe placebo is mainly made of lactose and starch with no active therapeutic ingredients as 8mm white

DRUGround

DRUGnormal convex tablets and encapsulated in gelatine.

DRUGDiclofenac Bluefish 50 mg enterotabletter

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to end of study (EoS) in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain between the active and the placebo group with the PRMS.	—

Secondary

Measure	Time frame
Change from baseline to EoS in KOOS pain., Change from baseline to EoS in ICOAP constant pain, intermittent pain, and the total ICOAP score., Difference in the observed standard deviation of the change from baseline to EoS in KOOS pain and ICOAP., Changes from baseline to EoS in pressure pain threshold (PPT) at relevant locations, temporal summation of pain (TSP), and conditioned pain modulation (CPM)., Change from baseline to EoS in KOOS function., Change from baseline to EoS in “40-meter walk test”., Change from baseline to EoS in number of placebo responders (≥30% and ≥50%)., Change from baseline to EoS in number of subjects meeting the OMERACT-OARSI responder criteria.	—

Measure

Time frame

Change from baseline to EoS in KOOS pain., Change from baseline to EoS in ICOAP constant pain, intermittent pain, and the total ICOAP score., Difference in the observed standard deviation of the change from baseline to EoS in KOOS pain and ICOAP., Changes from baseline to EoS in pressure pain threshold (PPT) at relevant locations, temporal summation of pain (TSP), and conditioned pain modulation (CPM)., Change from baseline to EoS in KOOS function., Change from baseline to EoS in “40-meter walk test”., Change from baseline to EoS in number of placebo responders (≥30% and ≥50%)., Change from baseline to EoS in number of subjects meeting the OMERACT-OARSI responder criteria.

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Countries

Denmark

Outcome results

None listed