UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039311
Receipt number R000044836
Scientific Title Effects of Exercise Therapy with Pleasant Emotion in Patients with Chronic Pain
Date of disclosure of the study information 2020/01/29
Last modified on 2020/03/11 18:14:17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of Exercise Therapy with Pleasant Emotion in Patients with Chronic Pain

Acronym

Effects of Exercise Therapy with Pleasant Emotion in Patients with Chronic Pain

Scientific Title

Effects of Exercise Therapy with Pleasant Emotion in Patients with Chronic Pain

Scientific Title:Acronym

Effects of Exercise Therapy with Pleasant Emotion in Patients with Chronic Pain

Region

Japan


Condition

Condition

chronic pain

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the effect of the combined effect of exercise therapy with pleasant emotion in patients with chronic pain on pain experience, pain and distress.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain Catastrophizing Scale

Key secondary outcomes

Hospital Anxiety Depression Scale
Numerical Rating Scale


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

10 minutes ergometer exercise with pleasant emotion (COM)

Interventions/Control_2

10 minutes ergometer exercise (EX)

Interventions/Control_3

viewing the video of pleasant emotion (PLE)

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 older than 16 years old
2 Pain lasts more than 3 months
3 Sit down for about 20 minutes
4 Can obey instructions of a healer
5 Patients with chronic pain who do not have pain or numbness in the central part of the left thigh to give pain stimulation to the central part of the left thigh

Key exclusion criteria

1 Those who have acute pain
2 Patients with a history of central illness, severe cardiopulmonary disease, or vascular disease
3 Those who can not stand the pain of the task
4 Those who use strong analgesics such as opioids
5 Those who your doctor does not allow for study participation

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazuhiro
Middle name
Last name Kimpara

Organization

Seirei Christopher University

Division name

Faculty of Rehabilitation Sciences

Zip code

433-8558

Address

3453 Mikatahara-Cho,Kita-ku,Hamamatsu-City,Shizuoka

TEL

053-439-1400

Email

kazuhiro-k@seirei.ac.jp


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Kimpara

Organization

Seirei Christopher University

Division name

Faculty of Rehabilitation Sciences

Zip code

433-8558

Address

3453 Mikatahara-Cho,Kita-ku,Hamamatsu-City,Shizuoka

TEL

053-439-1400

Homepage URL


Email

kazuhiro-k@seirei.ac.jp


Sponsor or person

Institute

Seirei Christopher University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Seirei Christopher University

Address

3453 Mikatahara-Cho,Kita-ku,Hamamatsu-City,Shizuoka

Tel

053-439-1400

Email

kazuhiro-k@seirei.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

2020 Year 01 Month 29 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

28

Results

This study showed that all of these groups can reduce pain catastrophic thinking. And exercise therapy with pleasant emotion let the brain of patients with chronic pain in a clam state while exercise therapy alone made it in a excite state.

Results date posted

2020 Year 03 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

28 patients with chronic pain

Participant flow


Adverse events


Outcome measures

NRS
HADS
PCS
PPT
CPM
TS
NIRS:LDLPFC
GSR

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 12 Month 26 Day

Date of IRB

2019 Year 04 Month 12 Day

Anticipated trial start date

2019 Year 04 Month 20 Day

Last follow-up date

2019 Year 11 Month 30 Day

Date of closure to data entry

2020 Year 03 Month 11 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 29 Day

Last modified on

2020 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044836


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name