Comparative efficacy of Phonophoresis with Nitroglycerin and Phonophoresis with Hydrocortisone in the treatment of plantar fasciitis, A randomized clinical trial
The purpose of this study is to compare the effect of Phonophoresis with Hydrocortisone and Phonophoresis with Nytroglycerin in the treatment of Plantar Fasciitis.
Design
A double-blind randomized controlled clinical trial with parallel groups and consist of 60 patients.
Settings and conduct
The 60 patients who refer to Isfahan physical medicine and rehabilitation centers and have clinical diagnosis of Plantar Fasciitis will enrolled in the study. 30 patients will participate in Phonophoresis with Hydrocortisone group and 30 patients in Phonophoresis with Nitroglycerin group.In each group 10 sessions of Phonophoresis will be done every other day in Amin Hospital.The amount of pain based on visual analuge scale and the amount of activity limitation based on modified Rolesand Maudsley score and thickness of plantar fascia will be assessed in each group.This study is a double-blind clinical trial that the patients don't know their treatment and The statistical consultant does not know the two methods of treatment and the name of the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients between 18 to 65 years with clinical diagnose of plantar fasciitis and ability to express the pain.
exclusion criteria include pregnancy and breastfeeding,allergy to nitrate ,hypertension and coronary artery disease,any pathology in foot and ankle ,Diabetes and peripheral neuropathy ,chronic pain syndrome and atrophy ,scar or wounds in heel.
Intervention groups
In this study, 30 patients with plantar fasciitis will participate in Phonophoresis with Hydrocortisone group and 30 patients in Phonophoresis with Nitroglycerin group.In each group 10 sessions of Phonophoresis will be done every other day.
Main outcome variables
The amount of pain based on (VAS) and the amount of activity limitation based on modified Rolesand Maudsley score (RMS) and thickness of plantar fascia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190824044598N2
Registration date:2020-03-02, 1398/12/12
Registration timing:registered_while_recruiting
Last update:2020-03-02, 1398/12/12
Update count:0
Registration date
2020-03-02, 1398/12/12
Registrant information
Name
Razieh Maghroori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3262 0338
Email address
raziehmaghroor@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of Phonophoresis with Nitroglycerin and Phonophoresis with Hydrocortisone in the treatment of plantar fasciitis, A randomized clinical trial
Public title
Comparison of Phonophoresis with Hydrocortison and Phonophoresis with Nitroglycerin in treatment of Plantar Fasciitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 to 65 years old with clinical diagnose of Plantar Fasciitis.
Ability to express pain
Exclusion criteria:
pregnancy and breastfeeding
allergy to nitrate
Diabetes and peripheral neuropathy
any pathology in foot and ankle
atrophy , scar or wound in the heel
hypertension and coronary artery disease
Chronic Pain Syndrome
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation: In this study, a specific code will be given to each of the individuals who are eligible for inclusion and exclusion criteria. Then 30 people will be allocated in the group of phonophoresis with nitroglycerin and 30 people in the group of phonophoresis with hydrocortisone.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main executor is considered as a physician who knows the goals of the study and the types of treatments. The patients don't know their treatment ( Phonophoresis with Hydrocortisone or Nitroglycerin ) and they will not be aware of how the treatments will be compared.The statistical consultant does not know the two methods of treatment and the name of the patients and he/she randomizingly assigne the codes to the patients and analyze the results.Therefore, this study is a double blind clinical trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8514933373
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.MUI.MED.REC.1398.154
Health conditions studied
1
Description of health condition studied
plantar fasciitis
ICD-10 code
M77.3
ICD-10 code description
Calcaneal spur
Primary outcomes
1
Description
The amount of pain
Timepoint
Before starting the study, after last session of Phonophoresis ,three weeks after the last session of Phonophoresis and two months after the last session of Phonophoresis.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : 30 patients participate in Phonophoresis with Nitroglycerin group and will treated with ultrasound (pulse mode, 0.8 MHZ frequency and 1.5 W/CM intensity) for 10 minutes in 10 sessions every other day.Maximum site of pain in heel will embarrassed with 1 gr Nitroglycerin 2% ointment before ultrasound therapy.
Category
Treatment - Drugs
2
Description
Intervention group : 30 patients participate in Phonophoresis with Hydrocortisone group and will treated with ultrasound (pulse mode, 0.8 MHZ frequency and 1.5 W/CM intensity) for 10 minutes in 10 sessions every other day.Maximum site of pain in heel will embarrassed with 2 gr Hydrocortisone 1% ointment before ultrasound therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Shiva Fakhari
Street address
Sonbolestan Aly., Ebnesina Ave., Shohada Sq.
City
Isfahan
Province
Isfehan
Postal code
8514933373
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghayegh Haghjoo
Street address
Hezar Jarib St., Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Alzahra@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shiva Fakhari
Position
Resident, Phisycal Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Niloofar Aly., Barazandeh St., Kaveh Ave.
City
Isfahan
Province
Isfehan
Postal code
8193964497
Phone
+98 31 3267 6848
Email
shiva.fakhari1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shiva Fakhari
Position
Resident, Phisycal Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Niloofar Aly., Barazandeh St., Kaveh Ave.
City
Isfahan
Province
Isfehan
Postal code
8193964497
Phone
+98 31 3267 6848
Email
shiva.fakhari1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shiva Fakhari
Position
Resident, Phisycal Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Niloofar Aly., Barazandeh St., Kaveh Ave.
City
Isfahan
Province
Isfehan
Postal code
8193964497
Phone
+98 31 3267 6848
Email
shiva.fakhari1@gmail.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