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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036019
Receipt No. 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

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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
Email 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
Email 17mr03@g.seirei.ac.jp

Sponsor
Institute Graduate School of Rehabilitation Sciences, Seirei Christopher University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040734

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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