UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050979 |
|---|---|
| Receipt number | R000058105 |
| Scientific Title | Spinal cord stimulation in elderly patients |
| Date of disclosure of the study information | 2023/05/03 |
| Last modified on | 2023/05/02 17:08:49 |
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Basic information
Public title
Spinal cord stimulation for failed back surgery syndrome in elderly patients: A Retrospective Study
Acronym
Spinal cord stimulation for failed back surgery syndrome in elderly patients: A Retrospective Study
Scientific Title
Spinal cord stimulation in elderly patients
Scientific Title:Acronym
Spinal cord stimulation in elderly patients
Region
| Japan |
Condition
Condition
Failed back surgery syndrome
Classification by specialty
| Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Spinal cord stimulation (SCS) has been reported useful for low back and leg pain due to FBSS. In this study, we studied the efficacy and safety of SCS for FBSS in older adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the comparison of VAS scores for low back pain, leg pain, and overall pain before and one year after surgery and RR (percentage of patients whose pain decreased by >50%) between the <75-year-old and >75-year-old groups of patients who underwent spinal cord stimulator implantation.
Key secondary outcomes
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
Eligible patients were older than 18 years; diagnosed with FBSS; had low back pain or leg pain persisting for at least three months; were non-responsive to drug therapy, physical therapy, and conservative treatment such as epidural block injection; and had a 100-mm visual analog scale (VAS) score of at least 50 mm for low back or leg pain. The interval between the last block injection and SCS implantation in the included patients is at least one month.
Key exclusion criteria
Patients with severe cognitive impairment or severe depression were excluded.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Higashiyama |
Organization
Akita Cerebrospinal and Cardiovascular Center
Division name
Department of Spinal Surgery
Zip code
010-0874
Address
6-10 Senshu Kubotamachi, Akita-shi, AKITA,Japan
TEL
+81188330115
higashiyama-naoki@akita-noken.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Higashiyama |
Organization
Akita Cerebrospinal and Cardiovascular Center
Division name
Department of Spinal Surgery
Zip code
010-0874
Address
6-10 Senshu Kubotamachi, Akita-shi, AKITA,Japan
TEL
+81188330115
Homepage URL
higashiyama-naoki@akita-noken.jp
Sponsor or person
Institute
Akita Cerebrospinal and Cardiovascular Center
Institute
Department
Personal name
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 ethical review board of the Akita Cerebrospinal and Cardiovascular Center
Address
6-10 Senshu Kubotamachi, Akita-shi, AKITA,Japan
Tel
+81188330115
kawata@akita-hos.or.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
| 2023 | Year | 05 | Month | 03 | 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
73
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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It was a single-center retrospective study in FBSS patients who underwent permanent spinal cord stimulator implantation between November 2017 and December 2020 at the Akita Cerebrospinal and Cardiovascular Center.
Management information
Registered date
| 2023 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058105
