UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pregabalin versus acetaminophen for a treatment of chronic neuropathic pain on extremities after cervical surgery: A prospective randomized, open-label preliminary study
Title of the study (Brief title)	A prospective randomized study for chronic neuropathic pain after cervical surgery
Region	Japan

Condition
Condition	CSM OPLL
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study was to evaluate the safety and analgesic effect of pregabalin compared with ac-etaminophen for residual neuropathic pain in patients who received a cervical operation and to investigate which functional domains improve after treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JOA score, JOACMEQ, NDI, VAS for pain These items will be evaluated until 8 weeks after treatment.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral administration of pregabalin
Interventions/Control_2	oral administration of acetaminophen
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1:surgery for cervical degeneration such as spondylosis, herniation, or ossification of the posterior longitudinal ligament; 2:diagnosis of neuropathic pain and/or numbness of the upper and/or lower extremities lasting for at least 3 months after the operation; 3: Neuropathic Pain Screening Question-naire (painDETECT) score greater than or equal to 6 and visual analog scale (VAS) of neuropathic pain of the upper and/or lower extremities greater than 40mm;
Key exclusion criteria	1: diagnosis of cancer pain; 2: history of neuronal blockage using a neuro-destructive agent within 6 months; 3: pain on the upper and/or lower extremities that are caused by a reason other than a spinal disorder; 4: significant motor deficits and/or bowel or bladder dysfunction; and 5: history of another spinal operation.
Target sample size	60

Research contact person
Name of lead principal investigator	Takashi Hirai
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Email	hirai.orth@tmd.ac.jp

Public contact
Name of contact person	Takashi Hirai
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedic Surgery
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5279
Homepage URL
Email	hirai.orth@tmd.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery, Tokyo Medical and Dental University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Orthopedic Surgery, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 05 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 23 Day
Last modified on	2016 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025829