UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of ergometer exercise on descending pain inhibitory system and sensitization of central nervous in Japanese patients with chronic pain
Title of the study (Brief title)	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	Shunsuke Sakuma
Organization	Graduate School of Rehabilitation Sciences, Seirei Christopher University
Division name	Graduate School of Rehabilitation Science
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	Shunsuke Sakuma
Organization	Graduate School of Rehabilitation Sciences, Seirei Christopher University
Division name	Graduate School of Rehabilitation Science
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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