Caio Cesar dos Santos Kasai
Pontifícia Universidade Católica do Paraná, Londrina, Brazil
Carlos Jose Figueredo Alcala
Albert Einstein College of Medicine/Montefiore Medical Center, New York, USA
Maria Isabel Jardim Pereira
Universidade de Brasília, Brasília, Brazil
Rosario del Carmen Almanzar Lora de Then
Instituto Tecnológico de Santo Domingo, Santo Domingo, Dominican Republic
Flabia Tejada Castro
Ministry of Public Health, Nutrition Department, Santo Domingo, Dominican Republic
Iloba Gabriel Njokanma
Department of Surgery, Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria
Rafael Firmino Ballester
Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
Ashraf Tahseen Basheer Hantouly
Orthopedic surgery department, Hamad Medical Corporation, Doha, Qatar
Renata Junqueira Moll Bernardes
D’Or Institute for Research and Education, Rio de Janeiro, Brazil
Rodrigo Gomes Taboada
A.C.Camargo Cancer Center, São Paulo, Brazil
Bandar Ahmed Alghamdi
Department of Surgery, College of Medicine in Al-Qunfudhah, Umm Al Qura University, Makkah, Saudi Arabia
Flavia de Oliveira Lima
Instituto Brasileiro de Controle do Cancer - IBCC, São Paulo, Brazil Hospital Regional Cristo Rei, Astorga, Brazil
Mariana Gasparoto Pereira Valerio
Hospital Regional Cristo Rei, Astorga, Brazil
Mauricio Fernando Silva Almeida Ribeiro
Hospital Sírio-Libanês, São Paulo, Brazil
Blanca Talavera de la Esperanza
Hospital Clínico Universitario de Valladolid, Valladolid, Spain
Thiago Tavares dos Santos
Hospital das Clínicas, Universidade de São Paulo, São Paulo, Brazil
Viviane Morais Cunha Lima
Santa Casa de Belo Horizonte, Belo Horizonte, Brazil
Banan Khalid Ibrahim Ahmed Khalid
Doha, Qatar, Hamad Medical corporation
Danny Michell Conde Monroy
Hospital Universitario Mayor Méderi, Bogota, Colombia
Bibiana Maryluz Romani
Hospital J. P. Garrahan, pediatric cardiolgy department, Buenos Aires, Argentina
Elbi Eulogio Morla Baez
Children Hospital, Santo Domingo, Dominican Republic
Merlin Marry Thomas
Department of Chest , Hamad General Hospital , Qatar and Weil Cornell Medical College, Doha, Qatar
Julio Cesar Robledo Cabello
General Medicine and Sport medicine ITESM, Mexico city, Mexico
Luiz Carlos Sa Junior
Hospital Evangélico, Belo Horizonte, Brazil
Maria Jose Aguilera Chuchuca
Brigham and Women's Hospital, Boston, MA, USA
Fathima Minisha
Hamad Medical Corporation, Doha, Qatar
Devy Veryuska Quiroz Robladillo
Universidad San Martin de Porres, Lima, Peru
Daniel Oswaldo Dávila-Rodríguez
General Surgery Service, High Specialty Regional Hospital Bicentennial of Independence, ISSSTE, State of Mexico, Mexico.
Abdu Haseeb
Department of clinical pharmacy, College of pharmacy, Umm Al Qura university, makkah, Saudi Arabia
Juan Carlos Silva Godínez
Hospital de Oncología, Centro Médico Nacional Siglo XXI, IMSS, Mexico
Abstract
Background and objectives: Osteoarthritis (OA) is a degenerative articular disease that affects approximately 240 million people worldwide, with knee OA accounting for 80% of this burden. One of the aims of pharmacological treatment in OA is to reduce pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are effective for pain relief in OA but have considerable renal, hepatic, cardiovascular, and gastrointestinal adverse effects, with the resultant increase in morbidity and mortality. Naltrexone is an orally activated opioid antagonist that has varied dose-dependent pharmacodynamic effects: Analgesic and anti-inflammatory effects are exhibited only at low dosage ranges of 0.5mg to 4.5mg (Low Dose Naltrexone LDN) while retaining a favorable adverse effect profile. This study aims to test the non-inferiority of LDN against Naproxen.
Methodology: This is a prospective phase II triple-blinded, two-arm, parallel-group, non-inferiority randomized controlled trial. The intervention group will receive low dose naltrexone 4.5 mg once daily, and the control group will receive extended-release naproxen 1000 mg once daily during the 12 week trial duration. Our sample size will be 118 patients recruited from a single Orthopedic referral center in the USA.
Discussion: The use of LDN for pain relief in osteoarthritis (OA) may be beneficial due to its favorable adverse effect profile. To the best of our knowledge, there is no published data on LDN use in OA even though preliminary evidence has documented its safety and tolerability in a variety of chronic pain conditions.
