hand osteoarthritis osteoarthritis
Conditions
Interventions
140 hand osteoarthritis patients (Kellgren-Lawrence classification grade 2 or higher) with high central sensitization (CSI 30 or higher) undergoing conservative treatment will be included in this stu
Sponsors
kohata kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Osteoarthritis patient (Kellgren Lawrence classification grade more than 2 with high central sensitization (CSI 30 or more) who have had pain for 3months or more and have been diagnosed with osteoarthritis based on the latest diagnostic criteria. 2) Those who are competent in the Japanese language and have ability to fill out quetionnaires 3) Aged more than 25 years 4) no matter of gender 5) Those who have received sufficient explanation for participating in this study, and have obtained the consent with sufficient understanding 6) Those who can come to outpatient clinic according to the research schedule
Exclusion criteria
Exclusion criteria: 1) Persons taking duloxetine hydrochloride or mechanism of action like duloxetine hydrochloride (serotonin noradrenaline reuptake inhibitor) within 7 days of obtaining consent 2) Persons with uncontrolled hypertension, severe liver damage, renal damage, or cardiovascular disease (judged by referring to Grade 3 of JCOG ,CTCAE version 5.0) 3) Persons with a history of hypersensitivity to the duloxetine hydrochloride or acetaminophen 4) Patients administering monoamine oxidase (MAO) inhibitors within two weeks 5) Patients with uncontrolled closed angle glaucoma 6) Persons with a history of serious side effects or serious drug allergies such as anaphylactic shock 7) Patients who fall under the precautions for the package insert (Patients with difficulty of urinating due to such as benign prostatic hyperplasia, Excessive alcohol drinkers, Patients with suicidal ideation or history of suicide attempt, Patient with manic depression, Patients with organic brain disorders or a predisposition to schizophrenia) 8) Persons with a history of trauma (such as fractures) within 6 months prior to obtaining consent 9) Patients who underwent surgery for the underlying disease within 6 months prior to obtaining consent 10) Patients who plan to undergo surgical therapy in their study period 11) Persons who are or may be pregnant 12) Persons who are nursing mothers 13 In addition, those who are judged by the research-responsible (sharing) doctor to be inappropriate for participation in this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of variation of the Disability of the Arm, Shoulder and Hand score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The amount of variation of Visual Analogue Scale for pain 2)The amount of variation of central sensitization inventory 3)The amount of variation of Pain Catastrophic Scale 4)The amount of variation of Self-Rating Depression Scale 5)Surgical hope survey 6) Safety of duloxetine (number of adverse events and incidence) | — |
Contacts
Public ContactKazuhiro Kohata
The University of Tokyo Hospital
Outcome results
None listed