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 |
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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
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
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
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
