UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016209 |
|---|---|
| Receipt number | R000016863 |
| Scientific Title | The effects of transcutaneous electrical nerve stimulation on postoperative pain in patients with hip fracture : a pilot case series study |
| Date of disclosure of the study information | 2015/07/12 |
| Last modified on | 2023/01/10 12:12:59 |
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Basic information
Public title
The effects of transcutaneous electrical nerve stimulation on postoperative pain in patients with hip fracture : a pilot case series study
Acronym
The effects of transcutaneous electrical nerve stimulation on postoperative pain in patients with hip fracture
Scientific Title
The effects of transcutaneous electrical nerve stimulation on postoperative pain in patients with hip fracture : a pilot case series study
Scientific Title:Acronym
The effects of transcutaneous electrical nerve stimulation on postoperative pain in patients with hip fracture
Region
| Japan |
Condition
Condition
hip fracture after surgery
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of study is to investigate the analgesic effect and the feasibility of transcutaneous electrical nerve stimulation to the hip fratcure patients who underwent arthroplasty or internal fixation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain intensity
Key secondary outcomes
Maximum voluntary isometric knee extension force
Maximum voluntary isometric hip abduction force
Usage of analgesia
Function independence measure(FIM)
Maximum amount of load
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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 | Maneuver |
Interventions/Control_1
traditional rehabilitation and transcutaneous electrical nerve stimulation(60min , every day , 1wee
Interventions/Control_2
traditional rehabilitation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hip fracture patients undergoing arthroplasty or internal fixation
Key exclusion criteria
severe comorbidities
dementia
severe sensory deficit
contraindications for electrical stimulation (e.g.,a pacemaker)
inability to give informed consent form
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takihguchi |
Organization
Yawatachuo Hospital
Division name
Department of Rehabilitation Medicine
Zip code
614-8071
Address
39-1 , Yawatagotanda , Yawatashi , Kyoto
TEL
075-983-0119
pt.takiguchi@gmail.com
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takiguchi |
Organization
Yawatachuo Hospital
Division name
Department of Rehabilitation Medicine
Zip code
614-8071
Address
39-1 , Yawatagotanda , Yawatashi , Kyoto
TEL
075-983-0119
Homepage URL
pt.takiguchi@gmail.com
Sponsor or person
Institute
Yawatachuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio-university
Address
4-2-2, Umaminaka, Koryocho, Kitakatsuragigun, Nara, 635-0832, Japan
Tel
0745-54-1601
soumu@kio.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
| 2015 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1002/ejp.1373
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1002/ejp.1373
Number of participants that the trial has enrolled
67
Results
the NFR magnitude of CS TENS group was significantly lower than that of the CP TENS group. There were no significant differences in VAS scores among the groups at any time point.
Results date posted
| 2023 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy particpants
Participant flow
Data from seven participants were excluded because of an unstable NFR response (n = 5) or equipment problems (n = 2). Thus, 60 participants completed the present study.
Adverse events
nothing
Outcome measures
Nociceptice Flexion Reflex
Subjective pain
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016863
