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General information
2019-11-06, 1398/08/15
2020-01-01, 1398/10/11
20192020-1101-0601 00:00:00
2019-11-06, 1398/08/15
2020-01-20, 1398/10/30
20192020-1101-0620 00:00:00
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Edit sampling date
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ویرایش تاریخ نمونه گیری
ویرایش تاریخ نمونه گیری
Recruitment centers
#1
Name of recruitment center - English: Firoozgar hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Dr.Gholamreza Raissi
Full name of responsible person - Persian: دکتر غلامرضا رئیسی
Street address - English: Firoozgar hospital,beh afarin St,Valiasr SQ;Tehran;Iran
Street address - Persian: تهران میدان ولیعصر خیابان به آفرین بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593748711
Phone: +98 21 8893 7902
Fax: +98 21 8894 2622
Email: H_Firoozgar@yahoo.com
Web page address:
Name of recruitment center - English: Firoozgar Hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Dr.Gholamreza Raissi
Full name of responsible person - Persian: دکتر غلامرضا رئیسی
Street address - English: Firoozgar Hospital,Beh Afarin St,Valiasr SQ;Tehran;Iran
Street address - Persian: تهران میدان ولیعصر خیابان به آفرین بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593748711
Phone: +98 21 8893 7902
Fax: +98 21 8894 2622
Email: H_Firoozgar@yahoo.com
Web page address:
Name of recruitment center - English: Firoozgar hospitalHospital Name of recruitment center - Persian: بیمارستان فیروزگر Full name of responsible person - English: Dr.Gholamreza Raissi Full name of responsible person - Persian: دکتر غلامرضا رئیسی Street address - English: Firoozgar hospital,beh afarinHospital,Beh Afarin St,Valiasr SQ;Tehran;Iran Street address - Persian: تهران میدان ولیعصر خیابان به آفرین بیمارستان فیروزگر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1593748711 Phone: +98 21 8893 7902 Fax: +98 21 8894 2622 Email: H_Firoozgar@yahoo.com Web page address:
Protocol summary
Study aim
To compare the clinical effectiveness of local botulinum toxin injection with corticosteroid injection for plantar fasciitis
Design
A total number of 40 patients will randomly be categorized into one of the following group,group A:will receive ultrasound guided localized injection of 150 units botulinum toxin in the intrinsic foot muscles.Group B: will receive ultrasound guided localized injection of 1 cc triamcinolone and 1 cc lidocaine in the plantar fascia.
Settings and conduct
This randomized control trial will be conducted in Firoozgar hospital, Tehran, Iran.this hospital is affiliated to the Iran university of medical sciences.Patients are randomly divided into two groups in closed packing.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Age between 18 to 75;A typical history of plantar fascitis and localized tenderness in the medial side of the heel;Exclusion criteria:Evidence of calcaneal fracture;history of heel surgery;inflammatory diseases;diabetes mellitus;local or systemic infections;gout;blood coagulation disorders
Intervention groups
Overall,40 patients will randomly be allocated equally into two groups
Main outcome variables
Pain intensity at the standing position;early morning pain;pain on joint movement,daily activities,climbing stairs and exercise tolerance.The outcomes are evaluated repeatedly up to 3 months after interventions.
General information
Reason for update
Edit sampling date
Acronym
PF
IRCT registration information
IRCT registration number:IRCT20190428043404N1
Registration date:2019-12-25, 1398/10/04
Registration timing:prospective
Last update:2020-08-24, 1399/06/03
Update count:1
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
Golam Reza Raissi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
raissi.gh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-01, 1398/10/11
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of ultrasound guided local injection of botulinum toxin type A with corticosteroid in treatment of chronic plantar fasciitis
Public title
Comparison of corticosteroid with botulinum toxin in treatment of chronic calcaneal spur
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
history of plantar fasciitis,patients suffering from heel pain with a VAS more than 4 months for at leate two month whose history
physical exam and sonography confirmed plantar fasciitis
Exclusion criteria:
History of direct trauma
other causes of heel pain( fracture,tumor,infection,nerve entrapement)
systemic inflammatory or soft tissue disease
disk herniation with S1 radiculopathy
poor controlled diabetes
history of gout
association with other causes of foot pain(severe osteoarthritis,morton neuroma,matatarsalgia)
surgery or injection in fascia since 6 month ago
coagulopathy
pregnancy
hypersensitivity to corticosteriod or botulinum toxin or lidocain
antibody against botulinum toxin
any treatment for the condition since 4 weeks ago
anti inflammatory drugs,physiotherapy,splint, iontophoresis, phonophoresis and shock wave in the last 3 month
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
patients are randomly divided into 2 groups in closed packing
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences (IUMS)
Street address
Iran university of Medical Sciences,Hemmat highway,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-12-04, 1397/09/13
Ethics committee reference number
IR.IUMS.FMD.REC.1397.091
Health conditions studied
1
Description of health condition studied
plantar fascial fibromatosis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
pain intensity at the standing position
Timepoint
All the outcomes were evaluated at the baseline visit,1 month and 3 months after the intervention.
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Early morning pain,pain on joint movement,daily activities,climbing stairs and exercise tolerance
Timepoint
All the outcomes were evaluated at the baseline visit,1 month and 3 months after the intervention
Method of measurement
Visual analog scale.we also assess the ability to perform daily activities,climbing stairs and exercise tolerance with FAAM questionnaire
Intervention groups
1
Description
Intervention group: will receive ultrasound guided localized injection of 150 unit botulinum toxin type A in the foot intrinsic muscles.
Category
Treatment - Drugs
2
Description
Control group:will receive ultrasound guided localized injection of 1 cc methylprednisolone and 1 cc normal saline 0.9% in the attachment of the plantar fascia to the calcaneal bone