UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033578 |
|---|---|
| Receipt number | R000038291 |
| Scientific Title | Usefulness of Pain Neuroscience education for frail elderly people with chronic pain in a local community: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2019/08/01 09:15:05 |
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Basic information
Public title
Usefulness of Pain Neuroscience education for frail elderly people with chronic pain in a local community: a pilot randomized controlled trial
Acronym
Usefulness of Pain Neuroscience education for frail elderly people with chronic pain in a local community: a pilot randomized controlled trial
Scientific Title
Usefulness of Pain Neuroscience education for frail elderly people with chronic pain in a local community: a pilot randomized controlled trial
Scientific Title:Acronym
Usefulness of Pain Neuroscience education for frail elderly people with chronic pain in a local community: a pilot randomized controlled trial
Region
| Japan |
Condition
Condition
Frail elderly people with chronic pain
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if it is feasible to undertake a clinical trial where we provide interventions with group exercises and with the group exercises and Pain Neuroscience education to pre-frail or frail elderly people with chronic pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recruitment rate of the participants per month
Key secondary outcomes
Drop-out rate
Number of group exercise sessions for 3 months
Home exercise compliance for 3 months
Grip strength (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Isometric knee extension strength (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Time during single leg standing with eyes open(pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Timed Up and Go test (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
10m walk test (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
P4 (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Pain Catastrophizing Scale (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Central Sensitization Inventory (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Tampa Scale for Kinesiophobia (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
SF-36 (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Revised Neurophysiology of Pain Questionnaire (pre intervention; 1, 2 and 3 months after the initiation of the intervention)
Global Rating Recovery Scale (1, 2 and 3 months after the initiation of the intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group exercise based on 'Ikiiki exercises for 100 years old' and locomotion training proposed by the Japanese Orthopedic Association for 60 minutes per week for 3 months
Home exercise with the locomotion training proposed by the Japanese Orthopedic Association everyday
Interventions/Control_2
Group exercise based on 'Ikiiki exercises for 100 years old' and locomotion training proposed by the Japanese Orthopedic Association for 60 minutes per week for 3 months
Home exercise with the locomotion training proposed by the Japanese Orthopedic Association everyday
A 80-minute lecture for Pain Neuroscience Education using power point slides
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Out-patients in Aoki Chuo Clinic, who has pain on the lower back or knee for at least 3 months
One or more out of 5 criteria are satisfied in the criteria proposed by the Cardiovascular Health Study (pre-frail or frail).
Key exclusion criteria
Out-patients for the purpose of post-surgical management
Scores of 21 or less in the Mini Mental State Examination
Difficulty of communication in Japanese
Patients who are not appropriate for exercise interventions (severe heart diseases, severe arthropathy, a history of cancer within 3 years, Parkinson's disease, and diseases with life expectancy of less than a year)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
3438540
Address
Sannomiya 820, Koshigaya, Saitama
TEL
+81489734706
takasaki-hiroshi@spu.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Mitsui |
Organization
Aoki Chuo Clinic
Division name
Rehabilitation
Zip code
3330861
Address
3-7-24, Yanagisaki, Kawaguchi, Saitama
TEL
+81482601213
Homepage URL
ffmrn222@yahoo.co.jp
Sponsor or person
Institute
Saitama Prefectural 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
Saitama Prefectural University
Address
Sannomiya 820, Koshigaya
Tel
+81489710500
rinri@spu.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
| 2018 | Year | 08 | Month | 10 | 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
0
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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038291
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
