UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055412 |
|---|---|
| Receipt number | R000063292 |
| Scientific Title | Observation of the effect of epidural electrical spinal cord stimulation on reducing neuropathic pain during voluntary movement |
| Date of disclosure of the study information | 2024/09/04 |
| Last modified on | 2024/09/05 17:41:14 |
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Basic information
Public title
Effect of epidural spinal cord stimulation during movement
Acronym
Trial for epidural electrical spinal cord stimulation during movement
Scientific Title
Observation of the effect of epidural electrical spinal cord stimulation on reducing neuropathic pain during voluntary movement
Scientific Title:Acronym
Epidural electrical spinal cord stimulation trial during voluntary movement
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Orthopedics | Anesthesiology | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Spinal epidural electrical stimulation has been widely used as a treatment for chronic neuropathic pain. By performing surgery to insert an electrode into the spinal epidural space, patients with chronic pain, especially neuropathic pain, can receive the pain relief effect of epidural electrical stimulation on a daily basis. The analgesic effect of spinal epidural electrical stimulation reduces the adverse effects on daily life and improves the quality of life. However, since the pain sensation is complex and its nature and cause vary by individuals, the analgesic effect of spinal epidural electrical stimulation may not be sufficient. In particular, when considering the example of physical exercise, it is known that some pain sensations are caused by exercise and some are relieved by exercise, but there are many unknowns regarding the relationship between neuropathic pain and physical exercise and the relationship with the analgesic effect of spinal epidural electrical stimulation. Therefore, this study aims to improve spinal epidural electrical stimulation into a more effective treatment, and to investigate the effect of physical exercise as one of the factors that may affect the analgesic effect of spinal epidural electrical stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective pain sensation during voluntary movement
Key secondary outcomes
Electromyograms for muscle activity assessment and behavioral assessment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had performed spinal epidural electrical stimulation electrodes placed in their bodies to treat chronic pain
Key exclusion criteria
Patients who are unable to express pain due to dementia or psychiatric disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Nagamatsu |
Organization
National Hospital Organization Sendai Nishitaga Hospital
Division name
Department of Neurosurgery
Zip code
982-8555
Address
2-11-11, Kagitori Honmachi, Taihaku-ku, Sendai City, Miyagi Prefecture
TEL
022-245-2111
naga@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Tsuji |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Neural Prosthetics Project
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
0353163100
Homepage URL
tsuji-hr@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohuku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the National Hospital Organization Sendai Nishitaga Hospital
Address
2-11-11, Kagitori Honmachi, Taihaku-ku, Sendai City, Miyagi Prefecture
Tel
022-245-2111
114-kanri01@mail.hosp.go.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
| 2024 | Year | 09 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
unpublished
Management information
Registered date
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063292
