UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037655 |
|---|---|
| Receipt number | R000042282 |
| Scientific Title | Research on Objective and non-invasive understanding of inflammatory findings and practicality as a rehabilitation tool. |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2022/04/29 21:58:54 |
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Basic information
Public title
Research on Objective and non-invasive understanding of inflammatory findings and practicality as a rehabilitation tool.
Acronym
Objective and non-invasive understanding of inflammatory findings and practicality as a rehabilitation tool.
Scientific Title
Research on Objective and non-invasive understanding of inflammatory findings and practicality as a rehabilitation tool.
Scientific Title:Acronym
Objective and non-invasive understanding of inflammatory findings and practicality as a rehabilitation tool.
Region
| Japan |
Condition
Condition
Distal radius fracture
Total knee arthroplasty
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing objectively and non-invasively the inflammatory findings of patients who have undergone surgery for musculoskeletal disease (osteotomy for distal radius fracture, total knee replacement for osteoarthritis) ,
Study 1: identify the practicality of objective and non-invasive evaluation of postoperative inflammatory findings.
Study 2: Examine the difference between patients who transited to chronic pain and patients who did not transit and their relationship with the patient's basic background and acute phase inflammation findings, and identify those at high risk of developing chronic pain.
Study 3: identify the effect and feasibility of comprehensive management and guidance for the patients at high risk of chronic pain from early stage including self-management for inflammation.
Through these series of research, we will search the beginning of early response to patients who are at high risk of transition to chronic pain, and reduce the chronic pain patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
[Heat sensation]
Therapist and the subject evaluate with non-contact type thermometer using Easythem HPC-01(Harasawa Pharmaceutical Industry), focusing on the central position of the affected area.
Key secondary outcomes
[Pain]
Visual Analogue Scale, SF-MPQ2, Pain Disability Assessment Scale(PDAS).
[Blood date]
Data of C-reactive protein and white blood cell count extracted from medical records(on the day of surgery, and 1day, 3day, 1week, and 2weeks after surgery).
[Swelling]
<Distal radius fracture>
Circumference diameter of hand(figure8 method)
<total knee arthroplasty>
Circumference diameter of thigh(patella superior rim, 5cm above, 10cm above),calf(maximum, minimum)
[Redness]
Choose the similar color with the affected area using the color guide(DIC color guide 20th, DIC corporation).
[Range of motion]
Evaluate active and passive range of motion of wrist and knee using goniometer.
[Muscle strength]
-Distal radius fracture
Grip strength(Jamar dynamometer)
-total knee arthroplasty
Isometric knee extension, flexion(handheld dynamometer).
[performance test]
-Distal radius fracture
Simple Test for Evaluating hand Function(STEF),
-total knee arthroplasty
10m gait speed(comfort speed, maximum speed)
[ADL] Barthel index
[QOL]
-Distal radius fracture
PRWE(Patient-Rated Wrist Evaluation The Japanese Version)
-total knee arthroplasty
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index), JKOM(Japanese Knee Osteoarthritis Measure).
[physical activity]
Physical activity from wakening to bedtime is measured by wristband accelerometer.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self monitering of hot sensation of affected area using a non-contact type thermometer and self management of hot sensation using cooling.
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received St. Marianna University school of medicine Hospital and underwent osteosynthesis for diagnosis of distal radius fracture and those for total knee arthroplasty for diagnosis of osteoarthritis of the knee.
The subject's inclusion criteria shall be: (1)physiotherapy and occupational therapy, or those who have had one or the other order, (2)over 50 years of age.
Key exclusion criteria
(1)Those who can not understand or answer the questions necessary for the evaluation of pain.
(2)Those who have cancer pain.
(3)Those who are defective in the measurement items for the research.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine Hospital
Division name
rehabilitation center
Zip code
216-8511
Address
Miyamae-ku Sugao2-16-1, Kawasaki city, Kanagawa Pref. Japan
TEL
044-977-8111
rehab-suzuki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Suzuk |
Organization
St. Marianna University School of Medicine Hospital
Division name
rehabilitation center
Zip code
216-8511
Address
Miyamae-ku Sugao2-16-1, Kawasaki city, Kanagawa Pref. Japan
TEL
044-977-8111
Homepage URL
rehab-suzuki@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine Hospital rehabilitation center
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine Hospital rehabilitation center
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
St. Marianna University School of Medicine Hospital
Address
Miyamae-ku Sugao2-16-1, Kawasaki city, Kanagawa Pref. Japan
Tel
044-977-8111
rehab-suzuki@marianna-u.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
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 22 | 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
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042282
| 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 |
