UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054957 |
|---|---|
| Receipt number | R000062793 |
| Scientific Title | Effect of Transcutaneous Electrical Nerve Stimulation on Patients with Vertebral Compression Fractures: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/07/13 |
| Last modified on | 2025/07/15 10:10:47 |
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Basic information
Public title
Effect of Transcutaneous Electrical Nerve Stimulation on Patients with Vertebral Compression Fractures: A Randomized Controlled Trial
Acronym
Effect of Transcutaneous Electrical Nerve Stimulation on Patients with Vertebral Compression Fractures: A Randomized Controlled Trial
Scientific Title
Effect of Transcutaneous Electrical Nerve Stimulation on Patients with Vertebral Compression Fractures: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Transcutaneous Electrical Nerve Stimulation on Patients with Vertebral Compression Fractures: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Patients with Acute Vertebral Compression Fractures
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of transcutaneous electrical nerve stimulation (TENS) on pain and physical function in patients with vertebral compression fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain assessed daily for two weeks from onset, then weekly; walking ability and lower limb muscle strength assessed weekly until discharge.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous Electrical Nerve Stimulation
100 microsecond
1~250Hz
Maximum current intensity at the sensory threshold
60min *2
Interventions/Control_2
only exercise
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
gait level higher than T-cane
Key exclusion criteria
Persons with complications of sensory disorders originating from peripheral nerves, such as diabetes mellitus, or from spinal nerve roots, such as spinal canal stenosis.
Patients with aphasia who cannot understand the research or the explanation of the assignment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Morikawa |
Organization
Heisei Memorial Hospital
Division name
Department of Rehabilitation
Zip code
6340813
Address
827 Shijyo-cho, Kashihara-city, Nara, 634-0813, JAPAN
TEL
0744-29-3300
yuki.morikawa.89@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Morikawa |
Organization
Heisei memorial Hospital
Division name
Department of Rehabilitation
Zip code
6340813
Address
827 Shijyo-cho, Kashihara-city, Nara, 634-0813, JAPAN
TEL
0744-29-3300
Homepage URL
yuki.morikawa.89@gmail.com
Sponsor or person
Institute
Heisei memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Heisei Memorial Hospital
Address
827 Shijyo-cho, Kashihara-city, Nara, 634-0813, JAPAN
Tel
0744293300
yuki.morikawa.89@gmail.com
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 | 07 | Month | 13 | 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 | 07 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 13 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062793
