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Comparative Effectiveness Of Ultrasound-Guided Dextrose injection And Radial Extracorporeal Shock Wave Therapy For The Treatment Of Chronic Plantar Fasciitis

Protocol summary

Study aim
Comparative Effectiveness Of Ultrasound-Guided Dextrose injection And Radial Extracorporeal Shock Wave Therapy For The Treatment Of Chronic Plantar Fasciitis
Design
Clinical trial with control group, with parallel groups, blinding is not done and randomization is done by closed envelopes.
Settings and conduct
This study was performed on patients with chronic plantar fasciitis referred to the PMR Clinics of IUMS . After performing physical examinations and the presence of tenderness in the medial part of the heel to confirm the diagnosis,lateral heel X-ray and diagnostic ultrasound will be performed.Patients are randomly assigned to be divided into two groups of 19 people. The treatment is performed at Firoozgar Hospital by a PMR resident.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: age 18 to 65 years, point tenderness of medial calcaneal tubercle, Heel pain with first step in the morning or after prolonged standing , thickness of plantar fascia greater than 4 mm in ultrasound and resistant to supportive treatments for at least three months Main exclusion criteria:coagulopathy,history of foot and ankle fracture or surgery,recent 6 weeks corticosteroid injection, bilateral plantar fasciitis, pregnancy and receive plantar fasciitis treatment in the last 6 months
Intervention groups
In the first group, 1.5 cc dextrose 20% plus 0.5 cc lidocaine 0.5% will be injected into the maximum thickness plantar fascia under ultrasound-guided in-plane injection technique.The cotrol group receive 3 sessions of low energy weekly.Shockwave Radial-SW type with Shock 2000 number, energy of 0.2 to 0.3 mJ / mm2 and frequency of 4 Hz focused on the Tenderness region.
Main outcome variables
The severity of morning and daily pain by Visual Analog Scale (VAS),Evaluation of foot and ankle function by Foot and Ankle Ability Measure (FAAM),Thickness of plantar fascia by Ultrasonography

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200223046590N1
Registration date: 2020-04-08, 1399/01/20
Registration timing: prospective

Last update: 2020-04-08, 1399/01/20
Update count: 0
Registration date
2020-04-08, 1399/01/20
Registrant information
Name
Lobaneh Janbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8855 3010
Email address
janbazi.l@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effectiveness Of Ultrasound-Guided Dextrose injection And Radial Extracorporeal Shock Wave Therapy For The Treatment Of Chronic Plantar Fasciitis
Public title
Effect of Dextrose injection in treatment of Chronic Plantar Fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's age 18 to 65 years Point Tenderness at the Medial Calcaneal Tubercle Heel pain with the first step in the morning or after prolonged standing Thickness of plantar fascia greater than 4 mm in ultrasound Resistant to supportive treatments for at least three months
Exclusion criteria:
Diabetes Mellitus Peripheral Neuropathy History of lower extremity radicular pain in L5 and S1 spinal segments Coagulation Disorders Vasculitis and Other Vascular Diseases Tarsal Tunnel Syndrome Instability of foot and ankle joints Foot and Ankle joints Arthritis Evidence of cancer Acute infection Skin diseases History of foot and ankle surgery History of foot and ankle fractures Corticosteroid injection in the last 6 weeks Bilateral Plantar Fasciitis Systemic Inflammatory Diseases Pregnancy Receive shockwave therapy or injectable plantar fasciitis treatment in the last 6 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Block, Unit of randomization: Individual, Tools used in randomization: Sealed Envelope
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
Ethics Committee of Iran Universiy of Medical Science
Street address
Medical faculty, Iran University of Medical Sience, Hemmat High way
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.IUMS.FMD.REC.1398.349

Health conditions studied

1

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

Primary outcomes

1

Description
The severity of morning and daily pain
Timepoint
قبل از تزریق و شاکویو تراپی ، 1 ماه و 3 ماه پس از تزریق و شاکویو تراپی
Method of measurement
Visual Analog Scale (VAS)

2

Description
Evaluation of foot and ankle function
Timepoint
Before injection and shock-wave therapy , 1 month and 3 months after injection and shock-wave therapy
Method of measurement
Foot and Ankle Ability Measure (FAAM)

3

Description
Thickness of plantar fascia
Timepoint
Before injection and shock-wave therapy , 1 month and 3 months after injection and shock-wave therapy
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 20% dextrose injection at maximal thickness location in plantar fascia under ultrasound-guided in-plane injection technique
Category
Treatment - Drugs

2

Description
Control group: 3 sessions of low energy weekly shock-wave therapy focused on the tenderness area
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Alireza Kazemian
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
kazemian11@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakooti
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8862 2553
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Kazemian
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
kazemian11@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Lobaneh Janbazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Floor 2, clinic building , Hazrat Fateme Hospital,23rd Ave, Yousef Abad street
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8855 3010
Email
janbazi.l@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Kazemian
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
kazemian11@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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