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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026637
Receipt No. R000030596
Scientific Title Observational study of tin splint for Heberden's nodule
Date of disclosure of the study information 2017/04/01
Last modified on 2019/03/24

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Basic information
Public title Observational study of tin splint for Heberden's nodule
Acronym Observational study of tin splint
Scientific Title Observational study of tin splint for Heberden's nodule
Scientific Title:Acronym Observational study of tin splint
Region
Japan

Condition
Condition Heberden's nodule
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of tin splint.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes numeric pain scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Frequency or duration of use was not specified, and patients were told to wear or remove the splints freely depending on the severity of their pain.
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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients with painful Hebreden's nodule.
Key exclusion criteria patients with secondary joint deformation due to comorbid conditions such as trauma, gout, or rheumatoid arthritis, and those with severe deformations with joint subluxation were excluded from the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kaoru
Middle name
Last name Tada
Organization Kanazawa University
Division name Department of orthopaedic surgery
Zip code 920-8641
Address Kanazawa
TEL 0762652000
Email tdkr@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Kaoru
Middle name
Last name Tada
Organization Kanazawa University
Division name Department of orthopaedic surgery
Zip code 920-8641
Address 13-1 takaramachi kanazawa
TEL 0762652000
Homepage URL
Email tdkr@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization nothing
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 Innovative Clinical Research Center, Kanazawa University
Address 13-1, takaramachi, kanazawa
Tel 076-265-2049
Email noaddress@kanazawa-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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 Day

Related information
URL releasing protocol http://ortho.w3.kanazawa-u.ac.jp/
Publication of results Unpublished

Result
URL related to results and publications http://ortho.w3.kanazawa-u.ac.jp/
Number of participants that the trial has enrolled 30
Results
The numeric pain scale showed significant pain improvement from 58.4 at baseline to 33.1 at one month, and Hand 20 score also showed significant improvement from 35.0 at baseline to 20.2 after 6 months. Active arc of motion were not changed significantly. Most patients responded that symptoms were relieved by the 10th day after treatment. Satisfaction related to usability was 8.9, and appearance was 7.6. 
Results date posted
2019 Year 03 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects of this prospective study included 30 patients with painful DIP joint osteoarthritis including 28 women and two men aged 46 to 85 years (mean, 68 years)
Participant flow
Patients were assessed before splint use and after 1, 3, and 6 months of splint use.
Adverse events
none
Outcome measures
Endpoints included NPS, active arc of motion of the DIP joint, Hand 20, and treatment satisfaction.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 05 Month 18 Day
Anticipated trial start date
2016 Year 05 Month 18 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 22 Day
Last modified on
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030596

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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