UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063064 |
|---|---|
| Receipt number | R000070571 |
| Scientific Title | Efficacy of Neuromuscular Electrical Stimulation on Paraspinal Muscle Myosteatosis in Patients with Vertebral Fractures: A Randomized Controlled Tria |
| Date of disclosure of the study information | 2026/09/26 |
| Last modified on | 2026/09/26 19:31:51 |
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Basic information
Public title
Efficacy of Neuromuscular Electrical Stimulation on Paraspinal Muscle Myosteatosis in Patients with Vertebral Fractures
Acronym
NMES for Paraspinal Muscle Myosteatosis in Vertebral Fractures
Scientific Title
Efficacy of Neuromuscular Electrical Stimulation on Paraspinal Muscle Myosteatosis in Patients with Vertebral Fractures: A Randomized Controlled Tria
Scientific Title:Acronym
Efficacy of Neuromuscular Electrical Stimulation on Paraspinal Muscle Myosteatosis in Patients with Vertebral Fractures
Region
| Japan |
Condition
Condition
patients with vertebral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of neuromuscular electrical stimulation (NMES) combined with standard rehabilitation on preventing the progression of paraspinal muscle myosteatosis and improving functional outcomes in patients with fresh osteoporotic vertebral fractures (OVF) through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Paraspinal Muscle Myosteatosis (Evaluate using MRI at BL, 6w, 3M)
Key secondary outcomes
1) Muscle strength: Handgrip strength measured using a digital handgrip dynamometer, and the Timed Loaded Standing Measure (TLSM) to reflect paraspinal muscle endurance by holding 900g dumbbells in both hands.
2) Back pain intensity: Evaluation of pain during movement using the Numerical Rating Scale (NRS).
3) Physical function: Assessment via the Short Physical Performance Battery (SPPB) and the 6-Minute Walk Distance.
4) Physical activity volume: Evaluation of a 3-day continuous physical activity level using a 3-axis accelerometer (Active style pro).
5) Activities of daily living (ADL) performance: Assessment using the Functional Independence Measure (FIM).
6) Quality of life (QOL): Evaluation using the EuroQol 5 dimensions 3-level (EQ-5D-3L) questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In addition to conventional rehabilitation (including early mobilization, locomotion training, core exercises, and ADL training), participants receive neuromuscular electrical stimulation (NMES) using a portable electrical stimulator (ESPURGE). Electrodes are placed on the paraspinal muscles from L1 to L5. The stimulation parameters are set at a frequency of 50 Hz, pulse width of 250 usec, on-time of 8 seconds, and off-time of 10 seconds, with the intensity adjusted to the maximum tolerable level for each participant. The intervention is administered for 15 minutes per session, twice a day, 5 days a week, for 6 weeks.
Interventions/Control_2
Alongside conventional rehabilitation (including early mobilization, locomotion training, core exercises, and ADL training), participants receive transcutaneous electrical nerve stimulation (TENS) that does not induce muscle contraction. Using the same portable device (ESPURGE), electrodes are placed on the paraspinal muscles from L1 to L5. The parameters are set at a frequency of 1-200 Hz and a pulse width of 200 usec, with the stimulation intensity kept at the sensory threshold level without inducing visible muscle contraction. The application schedule is identical to the intervention group: 15 minutes per session, twice a day, 5 days a week, for 6 weeks.
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with a fresh vertebral fracture via magnetic resonance imaging (MRI).
2) Pre-injury ambulation ability is at an independent level.
3) Mini-Mental State Examination (MMSE) score of 24 or higher.
4) Provided informed consent to participate in this study.
Key exclusion criteria
1)Contraindicated for MRI scans due to active implanted electronic devices, indwelling metals, or other restrictions.
2)Severe comobidity that make exercise difficult.
3)Paraspinal muscle myosteatosis between the fourth and fifth lumbar vertebrae (L4-L5) is 50% or higher.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kataoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
Nagasaki, Japan, 1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL
09022943107
kataoka-hide@kii.bbiq.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kataoka |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
852-8520
Address
1-7-1 Sakamoto Nagasaki city, 852-8520, Nagasaki, Japan
TEL
09022943107
Homepage URL
kataoka-hide@kii.bbiq.jp
Sponsor or person
Institute
Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee
Address
1-7-1 Sakamoto Nagasaki city, Nagasaki, Japan
Tel
095-819-7198
miyaji195@nagasaki-u.ac.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
| 2026 | Year | 09 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070571
