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Comparison of %1 hydrocortisone phonophoresis, low level laser and conventional therapy methods in the treatment of patients with lateral epicondylitis of elbow

Protocol summary

Summary
Lateral epicondylitis of elbow is the most common contractile lesion that causes inflammation and pain at the origin of the wrist extensor muscles. The aim of this study is comparing %1 hydrocortisone phonphoresis, low level laser and conventional therapy methods in the treatment of lateral epicondylitis of elbow. Seventy eight patients afflicted to lateral epicondylitis will refer to clinic of Fattemieh physiotherapy in Rafsanjan. Assessor evaluates the patients based on inclusion criteria, then he divided them to random permuted blocks methods in 3 equal groups and refers to therapist. Three methods of this study are %1 hydrocortisone phonphoresis (Ultrasound, ITO Japan with %1 hydrocortisone ointment), low power laser (GA AL AS, 810nm, 100mv) and conventional treatment of physiotherapy. Intensity of local pain, radicular pain, tenderness to palpation and grip strength are assessed during 1st, 5th, 10th sessions and 10 days after end of treatment. Inclusion criteria are pain at the origin of the wrist extensors muscles, radicular pain to forearm, tenderness at the origin of the wrist extensors. Exclusion criteria are previous fractures of humerus, radius and ulna, rheumatism arthritis of elbow, cervical disc herniation, disc degeneration and injection of corticosteroids. This study is a double blind clinical trial because both of patient and assessor are not aware of type of treatment methods but therapist is aware of type of treatment methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507043220N6
Registration date: 2015-09-03, 1394/06/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-03, 1394/06/12
Registrant information
Name
Dadollah Shahimoridi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0040
Email address
d_shahimoridi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2015-07-18, 1394/04/27
Expected recruitment end date
2016-05-16, 1395/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of %1 hydrocortisone phonophoresis, low level laser and conventional therapy methods in the treatment of patients with lateral epicondylitis of elbow
Public title
Effect of ultrasound associated with hydrocortisone and laser on epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pain at the origin of the wrist extensor muscles, radicular pain to forearm, tenderness at the origin of the wrist extensors. Exclusion criteria: previous fractures of humerus, radius and ulna, rheumatism arthritis of elbow, cervical disc herniation, disc degeneration and injection of corticosteroids
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Emam Ali street
City
Rafsanjan
Postal code
Approval date
2015-07-04, 1394/04/13
Ethics committee reference number
IR.RUMS.REC.9

Health conditions studied

1

Description of health condition studied
Lateral epicondylitis of the elbow
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
Tenderness
Timepoint
1st (before treatment), 5th, 10th sessions and 10 days after end of treatment
Method of measurement
By questionnaire

2

Description
Grip strength of hand
Timepoint
1st (before treatment), 5th, 10th sessions and 10 days after end of treatment
Method of measurement
By dynamometer

3

Description
Radicular pain
Timepoint
1st (before treatment), 5th, 10th sessions and 10 days after end of treatment
Method of measurement
By questionnaire

4

Description
Pain intensity at rest
Timepoint
1st (before treatment), 5th, 10th sessions and 10 days after end of treatment
Method of measurement
By Visual Analogue Scale(VAS)

Secondary outcomes

empty

Intervention groups

1

Description
First group will receive %1 hydrocortisone phonphoresis by Ultrasound, (ITO, 7P, 1MHZ, Japan) that is apply through 1.5 w/cm2 intensity continuous wave and 5 minutes per sessions plus %1 hydrocortisone ointment during 10 sessions on lateral epicondyle of elbow.
Category
Rehabilitation

2

Description
Second group will receive low power laser (GAL AL AS, 810nm, 100 mv, 5J) intensity on lateral epicondyle of elbow
Category
Rehabilitation

3

Description
Third group will receive conventional treatment of physiotherapy (infrared 10 minutes, ultrasound 1.5 w/cm2, 5 minutes and TENS 15 minutes) during 10 sessions on lateral epicondyle of elbow.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Fattemieh physiotherapy
Full name of responsible person
Dadollah Shahimoridi
Street address
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Rafsanjan University of Medical Sciences
Full name of responsible person
Hamid Hakimi
Street address
Rafsanjan University of Medical Sciences, Emam Ali street
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Academic member
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Emam Ali street
City
Rafsanjan
Postal code
Phone
+98 34 3428 0000
Fax
Email
d_shahimoridi@rums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Academic member
Other areas of specialty/work
Street address
Rafsanjan university of Medical Sciences, Emam Ali street
City
Rafsanjan
Postal code
Phone
+98 34 3428 0000
Fax
Email
d_shahimoridi@rums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Academic member
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Emam Ali street
City
Rafsanjan
Postal code
Phone
+98 34 3428 0000
Fax
Email
d_shahimoridi@rums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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