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

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 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


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

Value
https://center6.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