UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization	Saitama Prefectural University
Address	Sannomiya 820, Koshigaya
Tel	+81489710500
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038291