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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
