Effectiveness and safety of celecoxib combined with diacerein in the treatment of senile degenerative knee osteoarthritis: study protocol for a randomized controlled trial / 中国组织工程研究

ABSTRACT

BACKGROUND:The non-steroidal anti-inflammatory drug celecoxib,used for the treatment of senile degenerative knee osteoarthritis,has a rapid onset of action and few side effects.However,it cannot prevent the occurrence and development of knee osteoarthritis.Celecoxib withdrawal is likely to induce a rebound increase in inflammation that may aggravate symptoms.Diacerein is a drug used to improve articular cartilage metabolism.It can delay the progression of senile degenerative knee osteoarthritis,but has a slow onset of action.Whether combined treatment with celecoxib and diacerein provides complimentary actions to achieve a better therapeutic effect on senile degenerative knee osteoarthritis remains unclear.Whether combined treatment with celecoxib and diacerein provides complimentary actions to achieve a better therapeutic effect on senile degenerative knee osteoarthritis remains unclear.OBJECTIVE:To investigate the effectiveness and safety of celecoxib combined with diacerein in the treatment of senile degenerative knee osteoarthritis.METHODS:This is a prospective,single-center,randomized controlled trial.Three hundred patients with senile degenerative knee osteoarthritis who receive treatment at the Department of Orthopedics,Second Affiliated Hospital of Nanjing Medical University,China will be randomly assigned to celecoxib (200 mg,once a day,orally),diacerein (50 mg,twice a day,orally),and ccelecoxib+diacerein (celecoxib 200 mg,once a day,orally and diacerein 50 mg,twice a day,orally) groups,with 100 patients in each group.Patients in each group will be treated for 12 successive weeks,and a 36-week follow-up will be performed.The primary outcome measure of this study is the 20-meter walk pain visual analogue scale score before and 1,4,12,24,and 36 weeks after treatment.The secondary outcome measures of this study include osteoarthritis index and X-ray image findings of the knee before and 1,4,12,24,and 36 weeks after treatment,as well as the incidence of adverse events at 1,4,12,24,and 36 weeks after treatment.This study was approved by the Ethics Committee of the Second Affiliated Hospital of Nanjing Medical University,China (approval No.(2017)KY-091).The study protocol will be performed in strict accordance with the Declaration ofHelsinki formulated by the World Medical Association.Written informed consent of the study protocol and procedure will be obtained from each patient.Participant recruitment will begin in January 2018.Sample and data collection will begin in January 2018 and end in December 2018.Outcome measures will be analyzed in January 2020.The trial will end in February 2020.Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.This trial was registered with the Chinese Clinical Trial Registry (registration No.ChiCTR-IOR-17013867).DISCUSSION:Results from this study will help to determine whether celecoxib and diacerein complement each other to produce a long-acting,safe,reliable,and rapid-onset analgesic effect in patients with senile degenerative knee osteoarthritis.