Protocol summary
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Study aim
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To compare the clinical effectiveness of local botulinum toxin injection with corticosteroid injection for plantar fasciitis
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Overall,40 patients will randomly be allocated equally into two groups
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Main outcome variables
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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
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Reason for update
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Edit sampling date
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Acronym
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PF
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IRCT registration information
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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
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Registration date
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2019-12-25, 1398/10/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-01, 1398/10/11
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Expected recruitment end date
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2020-01-20, 1398/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial comparison of ultrasound guided local injection of botulinum toxin type A with corticosteroid in treatment of chronic plantar fasciitis
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Public title
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Comparison of corticosteroid with botulinum toxin in treatment of chronic calcaneal spur
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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simple randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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patients are randomly divided into 2 groups in closed packing
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-04, 1397/09/13
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Ethics committee reference number
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IR.IUMS.FMD.REC.1397.091
Health conditions studied
1
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Description of health condition studied
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plantar fascial fibromatosis
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ICD-10 code
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M72.2
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ICD-10 code description
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Plantar fascial fibromatosis
Primary outcomes
1
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Description
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pain intensity at the standing position
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Timepoint
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All the outcomes were evaluated at the baseline visit,1 month and 3 months after the intervention.
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Method of measurement
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Visual analog scale
Secondary outcomes
1
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Description
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Early morning pain,pain on joint movement,daily activities,climbing stairs and exercise tolerance
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Timepoint
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All the outcomes were evaluated at the baseline visit,1 month and 3 months after the intervention
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Method of measurement
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Visual analog scale.we also assess the ability to perform daily activities,climbing stairs and exercise tolerance with FAAM questionnaire
Intervention groups
1
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Description
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Intervention group: will receive ultrasound guided localized injection of 150 unit botulinum toxin type A in the foot intrinsic muscles.
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The study will be published in an article
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When the data will become available and for how long
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Just after publication
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To whom data/document is available
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researchers
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Under which criteria data/document could be used
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for research purpose
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From where data/document is obtainable
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from the indexing journal website
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What processes are involved for a request to access data/document
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the researcher must download the article
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Comments
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