UMIN-CTR Clinical Trial

Basic information
Public title	The study of the effect of Duloxisetine on postoperative residual pain, numbness and abnormal sensitivity after spinal surgery
Acronym	Effect of Duloxisetine on residual pain after spinal surgery
Scientific Title	The study of the effect of Duloxisetine on postoperative residual pain, numbness and abnormal sensitivity after spinal surgery
Scientific Title:Acronym	Effect of Duloxisetine on residual pain after spinal surgery
Region	Japan

Condition
Condition	Cervical spondylotic myelopathy Lumbar disc herniation Lumbar cannal stenosis Cervical disc herniation Thoracic disc herniation Ossification of posterior longitudinal ligament
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy on the residual pain, numbness and abnormal sensituvity after spinal surgery and safety of Duloxicetine, Pregabaline and An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of pain, numbness and abnormal sensitivity with Visual Analog Scale
Key secondary outcomes	JOA CMEQ JOA BPEQ

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients will receive for 3 months from the day after surgery. In Duloxisetin group, they will start medication from 20mg/day and increase up to 60mg/day weekly.
Interventions/Control_2	Patients will receive for 3 months from the day after surgery. In Pregabaline group, they will start medication from 50mg/day and increase up to 150mg/day weekly.
Interventions/Control_3	Patients will receive for 3 months from the day after surgery. In An Extract from Inflamed Cutaneous Tissue of Rabbits Inoculated with Vaccinia Virus gruop, they will start medication from 4U/day and keep this dose for 3 monts.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who performed spinal surgery
Key exclusion criteria	Patients who have allergy to drugs mental depression severe liver disease severe kidney disease gastrointestinal ulcer heart failure
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Wataru Middle name Last name Saito
Organization	Kitasato University School of Medicine
Division name	Department of Orhopaedic Surgery
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Email	wsaito@kiasato-u.ac.jp

Public contact
Name of contact person	1st name Wataru Middle name Last name Saito
Organization	Kitasato University School of Medicine
Division name	Department of Orhopaedic Surgery
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Homepage URL
Email	wsaito@kiasato-u.ac.jp

Sponsor
Institute	Department of Orhopaedic Suegery, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Kitasato institute, Clinical research Board
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel	042-778-8273
Email	rinrib@med.kitasato-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 18 Day
Date of IRB	2018 Year 01 Month 04 Day
Anticipated trial start date	2017 Year 12 Month 25 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 15 Day
Last modified on	2021 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034715