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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018869
Receipt No. R000021824
Scientific Title Prospective study about the efficacy of the elbowband for lateral epicondylitis
Date of disclosure of the study information 2015/09/03
Last modified on 2015/08/31

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Basic information
Public title Prospective study about the efficacy of the elbowband for lateral epicondylitis
Acronym prospective study for the efficacy of elbow band
Scientific Title Prospective study about the efficacy of the elbowband for lateral epicondylitis
Scientific Title:Acronym prospective study for the efficacy of elbow band
Region
Japan

Condition
Condition Lateral epicondylitis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this prospective randomised controlled multicentre study is to analyse the shortterm, middleterm, and longterm effects of a forearm band for treatment of lateral epicondylitis. Patients are randomly allocated into a band or nonband group, and results of each group will be compared.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome measure is Hand10 score. The Hand10 is a reliable and valid self-administered questionnaire used to evaluate upper extremity disorders.
Key secondary outcomes Secondary outcomes are pain score, patient satisfaction with the assigned treatment, and proportions of positive physical examinations, including assessment of tenderness, the Thomsen test, and the middle finger extension test.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients in the band group are instructed to wear a forearm band for more than six hours daily for at least six months. The band used in the current study is the Tennis Elbow Supporter. The band is 3 cm in width, and its proximal edge was placed 3 cm below the lateral epicondyle. Patients in the band group are instructed to perform wrist extensor stretching exercises in a standing position with their shoulder flexed to 90 degree, their elbow extended, and the opposite hand pulling their wrist into flexion. These exercises are performed for 30 seconds, 3 times daily, for 6 months.
Interventions/Control_2 Patients in the non-band group are instructed to perform wrist extensor stretching exercises in a standing position with their shoulder flexed to 90 degree, their elbow extended, and the opposite hand pulling their wrist into flexion. These exercises are performed for 30 seconds, 3 times daily, for 6 months.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients aged 18 years or more who had lateral epicondylitis are allocated into two groups. Lateral epicondylitis are diagnosed in patients who have both local tenderness to palpation just distal and anterior to the lateral epicondyle and a positive response to the Thomsen test.
Key exclusion criteria Patients are excluded from the study if they had (1) bilateral lateral epicondylitis, (2) osteoarthritis of the elbow observed on radiography, (3) a history of physical therapy in the previous six months, or (4) a history of elbow surgery.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Hirata
Organization Nagoya University Graduate School of Medicine
Division name Department of Hand Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL +81-52-744-2957
Email h-hirata@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanobu Nishizuka
Organization Nagoya University Graduate School of Medicine
Division name Department of Hand Surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL +81-52-744-2957
Homepage URL
Email nishizuka1@mail.goo.ne.jp

Sponsor
Institute Department of Hand Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
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 09 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 31 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021824

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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