UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039311
Receipt No. 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 (Ver. 4)

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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
Institute Seirei Christopher University
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044836