UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036019 |
|---|---|
| Receipt number | R000040734 |
| Scientific Title | Effects of ergometer exercise on descending pain inhibitory system and sensitization of central nervous in Japanese patients with chronic pain |
| Date of disclosure of the study information | 2019/02/26 |
| Last modified on | 2019/02/26 21:35:35 |
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Basic information
Public title
Effects of ergometer exercise on descending pain inhibitory system and sensitization of central nervous in Japanese patients with chronic pain
Acronym
Effects of ergometer exercise on descending pain inhibitory system and sensitization of central nervous in Japanese patients with chronic pain
Scientific Title
Effects of ergometer exercise on descending pain inhibitory system and sensitization of central nervous in Japanese patients with chronic pain
Scientific Title:Acronym
Effects of ergometer exercise on descending pain inhibitory system and sensitization of central nervous in Japanese patients with chronic pain
Region
| Japan |
Condition
Condition
chronic pain patients
Classification by specialty
| Clinical immunology | Surgery in general | Rehabilitation medicine |
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to clarify the effects of exercise on the neurophysiological mechanism of pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
conditioned pain modulation (CPM)
Key secondary outcomes
Firstly, numerical Rating Scale (NRS), Pain Catastrophizing Scale (PCS), Hospital Anxiety, Depression Scale (HADS) and determined pressure pain thresholds (PPTs). Functional near infrared spectroscopy (fNIRS) and galvanic skin response (GSR) were then attached at the resting position. Temporal summation (TS) and conditioned pain modulation (CPM) were evaluated at four minutes after rest.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
The control group was administered for 10 minutes with resting seated position.
Interventions/Control_2
The intervention group exercised for 10 minutes in a recumbent cycle.The exercise intensity was 40 to 60% of the Heart Rate Reserved (HRR).The intervention was made once.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subject was a person who visited a clinic at Terada pain during the research period and was prescribed physiotherapy.
Key exclusion criteria
Exclusion criteria are as follows: (1) those with acute pain, (2) those with a history of central disease, severe cardiopulmonary disease, vascular disease, (3) those who can not tolerate pain at the threshold level, (4) strong analgesics such as opioids (Including SSRI, SNRI, antidepressant medicine), (5) those who could not obtain the consent of the patient himself / herself for this research, (6) the doctor did not approve the research participation by the attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Sakuma |
Organization
Graduate School of Rehabilitation Sciences, Seirei Christopher University
Division name
Graduate School of Rehabilitation Science
Zip code
Address
3453 Mikatahara-Cho Kita-Ku Hamamatsu-City Shizuoka 433-8558 Japan
TEL
+81-53-439-1400
17mr03@g.seirei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Sakuma |
Organization
Graduate School of Rehabilitation Sciences, Seirei Christopher University
Division name
Graduate School of Rehabilitation Science
Zip code
Address
3453 Mikatahara-Cho Kita-Ku Hamamatsu-City Shizuoka 433-8558 Japan
TEL
+81-53-439-1400
Homepage URL
17mr03@g.seirei.ac.jp
Sponsor or person
Institute
Graduate School of Rehabilitation Sciences, Seirei Christopher University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Rehabilitation Sciences, Seirei Christopher 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
Address
Tel
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 | 02 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040734
