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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043394
Receipt No. R000049546
Scientific Title Effectiveness of physical therapy combined with patient education for subacute pain associated with fractures in the elderly
Date of disclosure of the study information 2021/02/21
Last modified on 2021/02/20

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Basic information
Public title Effectiveness of physical therapy combined with patient education for subacute pain associated with fractures in the elderly
Acronym Effectiveness of physical therapy combined with patient education for subacute pain
Scientific Title Effectiveness of physical therapy combined with patient education for subacute pain associated with fractures in the elderly
Scientific Title:Acronym Effectiveness of physical therapy combined with patient education for subacute pain
Region
Japan

Condition
Condition Hip fractures, Vertebral compression fracture
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of physical therapy combined with patient education for elder with subacute pain in a convalescence rehabilitation ward
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Subjective pain
Key secondary outcomes Quantitative sensory testing
Physical function
Cognitive and Emotional aspects of pain
Disability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Standard physical therapy and patient education
Interventions/Control_2 Standard physical therapy and distribution of patient education materials
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)We will include patients with diagnosis of hip fracture or vertebral compression fracture
Key exclusion criteria (1)We will exclude patients with other than hip fracture and vertebral compression fracture
(2) Affected area pain that lasts more than 3 months
(3) Difficult to evaluate due to significant cognitive impairment
(4) We will exclude neurological disease
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Takako
Middle name
Last name Matsubara
Organization Kobe Gakuin University
Division name Graduate School of Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL 0789741551
Email matsubar@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Takako
Middle name
Last name Matsubara
Organization Kobe Gakuin University
Division name Graduate School of Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL 0789741551
Homepage URL
Email matsubar@reha.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe Gakuin University
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe, JAPAN
Tel 0789741551
Email matsubar@reha.kobegakuin.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 えいしん会 岸和田リハビリテーション病院

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 21 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
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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 21 Day
Last follow-up date
2022 Year 01 Month 31 Day
Date of closure to data entry
2022 Year 01 Month 31 Day
Date trial data considered complete
2022 Year 02 Month 01 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 02 Month 20 Day
Last modified on
2021 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049546

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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