Protocol summary

Summary
Low power lasers have gained popularity over the 30 past years in the management of soft tissue injuries. Low -level lasers are used to accelerate wound healing, lessen pain, decreased inflammation and speed recovery of musculoskeletal injury. In this study the effects of methylprednisolone infusion weekly for three sessions are compared with laser for 10 sessions on 20 patients in each group. Patients followed up to 2 months after treatment for pain and tenderness in calcaneous. we conducted a trial to evaluated the efficacy of low-level laser therapy in comparison of local steroid injection in patients with plantar fascitis

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110247877N1
Registration date: 2011-12-14, 1390/09/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-14, 1390/09/23
Registrant information
Name
Batol Zamani
Name of organization / entity
Kasahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 4296
Email address
zamani-b@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2011-07-28, 1390/05/06
Expected recruitment end date
2012-07-26, 1391/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effect of low-power laser therapy versus local methylprednisolone injection on plantar fascitis in patients refer to rheumatology clinic
Public title
Comparison between effect of low-power laser therapy versus local methylprednisolone injection on plantar fascitis in patients refer to Rheumatology clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients have 22-65 years with unilateral plantar fascitis and duration of pain more than 6 week , Exclusion criteria:patients with bilateral Plantar fascitis; there was history of recent trauma or foot surgery; enrolled during recent 3-6 months therapeutic protocol; there was a previous diagnosis of rheumatoid arthritis; seronegative spondyloarthropathy; cacaneal stress fracture, osteomyelitis; plantar fascia neoplasm and plantar aponeurosis rupture
Age
From 22 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1390/1/5/29/پ

Health conditions studied

1

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

Primary outcomes

1

Description
The heel pain
Timepoint
After a night of rest and 6 weeks after treatment - after an active day and 6 weeks after treatment
Method of measurement
Visual analog scale

2

Description
Tenderness on the junction of plantar fascia
Timepoint
One and six weeks after treatment
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Infection at injection site
Timepoint
One and six weeks after injection
Method of measurement
Physical examination

Intervention groups

1

Description
Group 1: Methylprednisolone injection once a week for 3 weeks
Category
Treatment - Drugs

2

Description
Group2:Low-power laser in a ten session in every other day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.Kashan University of Medical Sciences
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
kashan Univercity of Medical Sciences
Full name of responsible person
Dr.Batol Zamani
Position
Specialist Rheumatology
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Bulv.Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1555 4296
Fax
Email
batol_zamani2007@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr.Batol Zamani
Position
Specialist Rheumatology
Other areas of specialty/work
Street address
5th Kilometer Ravand Bulv. Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
batol_zamani2007@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr.Batol Zamani
Position
Specialist Rheumatology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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