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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033578
Receipt No. R000038291
Official scientific title of the study 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 2018/07/31

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Basic information
Official scientific title of the study Usefulness of Pain Neuroscience education for frail elderly people with chronic pain in a local community: a pilot randomized controlled trial
Title of the study (Brief title) 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 Hiroshi Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Address Sannomiya 820, Koshigaya, Saitama
TEL +81489734706
Email takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person Naoto Mitsui
Organization Aoki Chuo Clinic
Division name Rehabilitation
Address 3-7-24, Yanagisaki, Kawaguchi, Saitama
TEL +81482601213
Homepage URL
Email ffmrn222@yahoo.co.jp

Sponsor
Institute Saitama Prefectural 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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 31 Day
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 31 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038291

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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