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The comparison of %1 hydrocortisone phonophoresis with low power laser on treatment of 2nd degree ankle sprain.

Protocol summary

Summary
Ankle sprain is the most common ankle injuries and divide to three degree 1, 2, 3 or mild, moderate and severe. The aim of this study is to comparison of %1 hydrocortisone phonophoresis with low power laser on treatment of second degree (moderate) ankle sprain. This is a double blinded randomized clinical trial.90 patients that afflicted to ankle sprain will refer to clinical of Fattemieh physiotherapy in Rafsanjan, Iran. They will be divided in to 3 equal groups randomly. Three intervention of this study are%1 hydrocortisone phonophoresis (Ultrasound, ITO Japan with %1 hydrocortisone ointment), low power laser (Ga AL AS, 810nm, 100mV) and current treatments of physiotherapy. Intensity of pain, improvement of movement and reduction of inflammation are assessed during 1st, 5th and 10th sessions. Inclusion criteria are pain in medial and lateral malleolus, inflammation of ankle. Exclusion criteria are Achilles tendon injuries, fractures and dislocations of ankle.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307233220N5
Registration date: 2013-09-13, 1392/06/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-09-13, 1392/06/22
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
2013-10-08, 1392/07/16
Expected recruitment end date
2014-08-07, 1393/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of %1 hydrocortisone phonophoresis with low power laser on treatment of 2nd degree ankle sprain.
Public title
Comparison of phonophoresis and laser in the treatment of second degree ankle sprain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pain in medial and lateral malleolus; inflammation of ankle stiffness of ankle and ecchimosis around ankle. Exclusion criteria: Achilles tendon injuries; fractures and dislocations of ankle.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Rafsanjan University of Medical Science
Street address
Emam Ali ave
City
Rafsanjan
Postal code
7717893591
Approval date
2013-09-01, 1392/06/10
Ethics committee reference number
273

Health conditions studied

1

Description of health condition studied
Ankle sprain
ICD-10 code
M25
ICD-10 code description
Other joint disorders, not elsewhere classified

Primary outcomes

1

Description
Pain intensity at rest
Timepoint
1st(before treatment),5th and 10th sessions
Method of measurement
by visual analogue scale (VAS)

2

Description
Inflammation around ankle
Timepoint
1st(before treatment),5th and 10th sessions
Method of measurement
by meter (cm)

3

Description
Ankle movment
Timepoint
1st(before treatment),5th and 10th sessions
Method of measurement
by goniameter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: first group will receive %1 hydrocortisone phonophoresis by ultrasound ITO .7p .1 MHZ, Japan that is apply through 1.5 w/〖cm〗^2 intensity, continues wave and 5 minutes per session plus %1 hydrocortisone ointment during 10 sessions around ankle.
Category
Rehabilitation

2

Description
Intervention: second group will receive low power laser (Gal AL AS, 810nm, 100mv) through 5j intensity and 5 minutes per session on the ankle.
Category
Rehabilitation

3

Description
Control: third group (current treatment) will receive infrared (10 minutes) ultrasound 1.5 w/〖cm〗^2, 5 minutes) and TENS (15 minutes) per session during 10 session on ankle.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Fattemieh physiotherapy clinic
Full name of responsible person
Dadallah shahimoridi
Street address
Rafsanjan moalem street 17 avenue
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Reza Derakhshan
Street address
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
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
Dadallah Shahimoridi
Position
Academic member
Other areas of specialty/work
Street address
Rafsanjan- Ali Ebn Abitaleb department of physiotherapy
City
Rafsanjan
Postal code
Phone
+98 39 1822 0000
Fax
+98 39 1822 0097
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
Dadallah Shahimoridi
Position
Master of science(MS)
Other areas of specialty/work
Street address
Rafsanjan- Ali Ebn Abitaleb hospital
City
Rafsanjan
Postal code
Phone
+98 39 1822 0000
Fax
+98 39 1822 0097
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
Dadallah Shahimoridi
Position
Academic member
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences
City
Rafsanjan
Postal code
Phone
+98 39 1822 0097
Fax
+98 39 1822 0097
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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