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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019235
Receipt No. R000022231
Scientific Title Effects of splinting for Mallet Finger of the Tendon Origin
Date of disclosure of the study information 2015/10/10
Last modified on 2015/10/05

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Basic information
Public title Effects of splinting for Mallet Finger of the Tendon Origin
Acronym Effects of splinting for Mallet Finger of the Tendon Origin
Scientific Title Effects of splinting for Mallet Finger of the Tendon Origin
Scientific Title:Acronym Effects of splinting for Mallet Finger of the Tendon Origin
Region
Japan

Condition
Condition mallet finger of tendon origin
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the efficacy of two-step splinting to treat mallet finger of tendon origin, with the first splint immobilizing the finger with the proximal interphalangeal (PIP) joint flexed and the distal interphalangeal (DIP) joint slightly extended, followed by a second splint immobilizing it with the DIP joint extended.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Assessments were carried out twice: an initial assessment at the first visit, and another at the end of treatment in week 16. The following items were compared between patients in the control group and those treated by two-step splinting: (1) sex, (2) age, (3) injured finger, (4) range of motion (ROM) of active flexion of the DIP joint at the first visit, (5) ROM of active flexion of the DIP joint at the end of treatment, (6) ROM of active extension of the DIP joint at the start of immobilization, (7) ROM of active extension of the DIP joint at the end of treatment, (8) visual analog scale (VAS) pain score at the first visit, (9) VAS pain score at the end of treatment, and (10) outcome (three-grade evaluation according to Abouna and Brown's criteria.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
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 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients were divided into two groups, a control group that underwent conventional immobilization with the DIP joint slightly extended,
Interventions/Control_2 and a two-step immobilization group that underwent treatment with an initial first splint that immobilized the finger with the PIP joint flexed and the DIP joint slightly extended, followed by a second splint that immobilized the DIP joint slightly flexed in the conventional manner.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria were mallet finger with or without fracture, age 18 years or greater, and treatment with a period of continuous orthosis immobilization for 6 weeks or 8 weeks.
Key exclusion criteria Exclusion criteria included open lesions, mallet fractures with subluxation of the distal interphalangeal joint (DIP), with delayed treatment of more than 2 weeks,
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Saito
Organization Fuchinobe General Hospital
Division name The departments of Rehabilitation Center
Zip code
Address 3-2-8 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa
TEL 042-754-2222
Email kasuo_saitoh@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Saito
Organization Fuchinobe General Hospital
Division name The departments of Rehabilitation Center
Zip code
Address 3-2-8 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa
TEL 042-754-2222
Homepage URL
Email kasuo_saitoh@yahoo.co.jp

Sponsor
Institute Fuchinobe General Hospital
Institute
Department

Funding Source
Organization Fuchinobe General Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 10 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
Results
We found that both, the angle of extension of the DIP joint and pain improved significantly by the end of treatment for all patients in both groups (p<0.001). A comparison between the two groups showed a greater improvement in both, DIP joint extension angle and outcome criteria among patients treated with two-step splinting (p<0.010, p< 0.011).
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 Completed
Date of protocol fixation
2011 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2014 Year 07 Month 01 Day
Date of closure to data entry
2014 Year 07 Month 01 Day
Date trial data considered complete
2014 Year 07 Month 01 Day
Date analysis concluded
2015 Year 07 Month 01 Day

Other
Other related information Our study thus suggested that the initial immobilization involved in two-step splinting and is thus a good immobilization technique.

Management information
Registered date
2015 Year 10 Month 05 Day
Last modified on
2015 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022231

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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