UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037555 |
|---|---|
| Receipt number | R000042813 |
| Scientific Title | Elucidation of the neuronal mechanism of analgesic action of transcutaneous electrical nerve stimulation for chronic musculoskeletal pain: Randomized controlled trial |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2019/07/31 13:02:02 |
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Basic information
Public title
Elucidation of the neuronal mechanism of analgesic action of transcutaneous electrical nerve stimulation for chronic musculoskeletal pain: Randomized controlled trial
Acronym
Elucidation of the neuronal mechanism of analgesic action of TENS for chronic musculoskeletal pain
Scientific Title
Elucidation of the neuronal mechanism of analgesic action of transcutaneous electrical nerve stimulation for chronic musculoskeletal pain: Randomized controlled trial
Scientific Title:Acronym
Elucidation of the neuronal mechanism of analgesic action of TENS for chronic musculoskeletal pain
Region
| Japan |
Condition
Condition
Chronic neck pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To shed light on the neuronal mechanism of analgesic action of transcutaneous electrical nerve stimulation for chronic musculoskeletal pain, we examine the changes in resting-state functional connectivity before and after electrical stimulation therapy in patients with musculoskeletal pain using Near-infrared spectroscopy and electroencephalography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral hemodynamics (Oxy-Hb, Deoxy-Hb, Total-Hb)
Key secondary outcomes
Neuronal Activity
Visual Analog Scale (VAS)
Pain Pressure Threshold (PPT)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Trigger point
Interventions/Control_2
Non-Trigger point
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients over 20 years of age
2)Patients who complain of neck pain over 3month from the onset
3)Patients with trapezius myofascial trigger points
Key exclusion criteria
1)Patients with a history of neck surgery
2)Patients with cervical fracture or dislocation
3)Patients with an abnormality in neurologic findings
4)Patients who take analgesic drug
5)Patients who have a history of complaints of systemic pain or a history of rheumatoid arthritis, metastasis such as tumor, fibromyalgia, tumors of the spine or intervertebral disc, infectious diseases, or systemic pain
6)pregnant woman
7)Patients who had treatments (massage, acupuncture, nerve block treatment, etc.) for neck pain within one month
8) Patients with a history of whiplash injury caused by traffic accidents
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Hisao |
| Middle name | |
| Last name | Nishijo |
Organization
University of Toyama
Division name
Department of system emotional science
Zip code
930-0194
Address
2630,Sugitani, Toyama, Japan
TEL
076-434-7218
nishijo@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hibi |
Organization
University of Toyama
Division name
Department of anesthesiology
Zip code
930-0194
Address
2630,Sugitani, Toyama, Japan
TEL
076-434-7218
Homepage URL
d1661011@ems.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
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
Ethics Committee, University of Toyama
Address
2630,Sugitani, Toyama, Japan
Tel
076-434-7681
rinri@adm.u-toyama.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
| 2019 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042813
