title: Clinical Usefulness of Long-term Application of Fentanyl Matrix in Chronic Non-Cancer Pain: Improvement of Pain and Physical and Emotional Functions.
abstract: BACKGROUND
  Opioids are recently recommended for those who do not gain adequate pain relief from the use of acetaminophen or nonsteroidal anti-inflammatory drugs. Medical opioids are administered in various routes, and transdermal opioid products that can make up for the weaknesses of the oral or intravenous products have been developed. This study is to evaluate the clinical usefulness of fentanyl matrix in terms of the long-term improvement in pain and physical and mental functions.
  
  
  METHODS
  This was a multicenter, open, prospective, observational study that was conducted in 54 institutions in Korea. Patients with non-cancerous chronic pain completed questionnaires, and investigators also completed questionnaires. A total of 1,355 subjects participated in this study, and 639 subjects completed the study. Subjects received transdermal fentanyl matrix (12 µg/hr, 25 µg/hr, or 50 µg/hr depending on the patient's response and demand). Subjects visited at 29 ± 7 days, 85 ± 14 days, and 169 ± 14 days after administration, respectively, to receive drug titration and fill out the questionnaires. The results were analyzed using the intention-to-treat (ITT) analysis, full analysis set (FAS), and per-protocol (PP) analysis. The FAS analysis included only 451 participants; the PP analysis, 160 participants; and the ITT analysis, 1,355 participants.
  
  
  RESULTS
  The intensity of pain measured by the Numeric Rating Scale decreased from 7.07 ± 1.78 to 4.93 ± 2.42. The physical assessment score and mental assessment score of the Short-Form Health Survey 12 improved from 28.94 ± 7.23 to 35.90 ± 10.25 and from 35.80 ± 11.76 to 42.52 ± 10.58, respectively. These differences were significant, and all the other indicators also showed improvement. Adverse events with an incidence of ≥ 1% were nausea, dizziness, vomiting, and pruritus.
  
  
  CONCLUSIONS
  The long-term administration of fentanyl matrix in patients with non-cancerous pain can reduce the intensity of pain and significantly improves activities of daily living and physical and mental capabilities.
authors.affiliation: Department of Orthopedic Surgery, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
authors.forename: Jaewon
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Physical Medicine and Rehabilitation, Korea University College of Medicine, Seoul, Korea.
authors.forename: Joon Shik
authors.initials: JS
authors.lastname: Yoon
authors.affiliation: Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jae Hyup
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Orthopedic Surgery, Kosin University Gospel Hospital, Kosin University School of Medicine, Busan, Korea.
authors.forename: So-Hak
authors.initials: SH
authors.lastname: Chung
authors.affiliation: Department of Orthopedic Surgery, Dong-A University College of Medicine, Busan, Korea.
authors.forename: Kyu-Yeol
authors.initials: KY
authors.lastname: Lee
authors.affiliation: Department of Orthopedic Surgery, Daejeon St. Mary's Hospital, The Catholic University of Korea College of Medicine, Daejeon, Korea.
authors.forename: Young Yul
authors.initials: YY
authors.lastname: Kim
authors.affiliation: Department of Rehabilitation, Konkuk University College of Medicine, Chungju, Korea.
authors.forename: Jong Moon
authors.initials: JM
authors.lastname: Kim
authors.affiliation: Department of Neurosurgery, Seoul Medical Center, Seoul, Korea.
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Kong
authors.affiliation: Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ung Gu
authors.initials: UG
authors.lastname: Kang
authors.affiliation: Department of Orthopedic Surgery, Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
authors.forename: Ye-Soo
authors.initials: YS
authors.lastname: Park
mesh_terms: D000339:Affect / Q000187:drug effects; D059350:Chronic Pain / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D005283:Fentanyl / Q000627:therapeutic use*; D006801:Humans; D010147:Pain Measurement; D011446:Prospective Studies; D012890:Sleep / Q000187:drug effects
chemical_list: D005283:Fentanyl
keywords: Chronic non-cancer pain; Emotional functioning; Fentanyl matrix; Physical functioning