UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022408
Receipt number R000025829
Scientific Title Pregabalin versus acetaminophen for a treatment of chronic neuropathic pain on extremities after cervical surgery: A prospective randomized, open-label preliminary study
Date of disclosure of the study information 2016/05/25
Last modified on 2016/05/23 13:25:46

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Basic information

Public title

Pregabalin versus acetaminophen for a treatment of chronic neuropathic pain on extremities after cervical surgery: A prospective randomized, open-label preliminary study

Acronym

A prospective randomized study for chronic neuropathic pain after cervical surgery

Scientific Title

Pregabalin versus acetaminophen for a treatment of chronic neuropathic pain on extremities after cervical surgery: A prospective randomized, open-label preliminary study

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Takashi Hirai

Organization

Tokyo Medical and Dental University

Division name

Department of Orthopedic Surgery

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5279

Email

hirai.orth@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Hirai

Organization

Tokyo Medical and Dental University

Division name

Department of Orthopedic Surgery

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5279

Homepage URL


Email

hirai.orth@tmd.ac.jp


Sponsor or person

Institute

Department of Orthopedic Surgery, Tokyo Medical and Dental University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

2011 Year 08 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025829


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name