Protocol summary

Summary
Plantar fasciitis has very important performance in the function of foot. The over stretching on this fascia causes inflammation and calcaneal pain. The aim of this study is to investigate the effect of low power laser on plantar fasciitis. This is a double-blinded randomized clinical trial. Fifty patients will refer to clinic of Fattemieh physiotherapy in Rafsanjan. They will be divided into two equal groups randomly. Two intervention of this study are low power laser (Gal Al As,810nm,100mV) and placebo. Severity of local pain, radicular pain, sensitivity to palpation and morning pain will be assessed in the 1st, 5th, 10th sessions. Main inclusion criteria are calcaneal pain, radicular pain and sensitivity to palpation. Main exclusion criteria are calcaneal fracture, rheumatoid arthritis and injection of corticosteroids.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811093220N1
Registration date: 2011-09-21, 1390/06/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-09-21, 1390/06/30
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
2010-02-09, 1388/11/20
Expected recruitment end date
2012-02-09, 1390/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low power laser in the treatment of planter fasciitis
Public title
The effect of laser on planter fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: calcaneal pain; radicular pain; sensitivity to palpation; morning pain. Exclusion: calcaneal fracture; diabetes; rheumatoid arthritis; injection of corticosteroids during last month.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Emam Ali street
City
Rafsanjan
Postal code
7717893591
Approval date
2009-12-12, 1388/09/21
Ethics committee reference number
851/20/9

Health conditions studied

1

Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fasciitis fibromatosis

Primary outcomes

1

Description
Radicular pain
Timepoint
1st (before treatment), 5th and 10th sessions
Method of measurement
By question from patient

2

Description
Intensity of local pain
Timepoint
1st (before treatment), 5th and 10th sessions
Method of measurement
Through Visual Analogue Scale (VAS)

3

Description
Sensitivity to palpation
Timepoint
1st (before treatment), 5th and 10th sessions
Method of measurement
By press calcaneal area and question from patient

4

Description
Morning pain
Timepoint
1st (before treatment), 5th and 10 sessions
Method of measurement
By question from patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: Low power laser (Gal AL AS, 810 nm, 100mv) is applyed by 6 Joul and 3 minutes during 10 sessions on calcaneal pain area.
Category
Rehabilitation

2

Description
Control group (placebo): Laser set is on but intensity (dose) of device turn off and then applicator of set is applyed on calcaneal area during 10 sessions and 3 minutes per session.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fattemieh physiotherapy
Full name of responsible person
Dadollah Shahimoridi
Street address
Moalem street, alley 17
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Raza Vazirinejad
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
Dadollah Shahimoridi
Position
Academic member
Other areas of specialty/work
Street address
Emam Ali street, Rafsanjan University of Medical Sciences
City
Rafsanjan
Postal code
7717893591
Phone
+98 39 1822 0038
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
Dadollah Shahimoridi
Position
MSc of physioterapy
Other areas of specialty/work
Street address
Emam Ali street
City
Rafsanjan
Postal code
7717893591
Phone
+98 39 1322 7928
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
ِDadollah Shahimoridi
Position
Instructor/Academic member
Other areas of specialty/work
Street address
Emam Ali street
City
Rafsanjan
Postal code
7717893591
Phone
+98 39 1322 7928
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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