UMIN-CTR Clinical Trial

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

Lateral epicondylitis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Hand Surgery, Nagoya University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

03

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2015

Year

08

Month

31

Day

Last modified on

2015

Year

08

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021824