Comparison of the High Intensity laser Therapy (HILT) with Extra corporeal Shock Wave Therapy (ESWT) in the treatment of patients with plantar fasciitis
Provide less invasive methods in the treatment of patients with plantar fasciitis;
Providing the best non-invasive treatment in patients with plantar fasciitis
Provide a new proposal to physicians to reduce the rate of invasive measures
Provide results for larger studies in the field of shock wave and laser therapy and determine the appropriate therapeutic dose;
Design
without control group, with parallel groups, one-way blind, randomized, on 56 patients.Online randomization will be used for randomization, which will be done using the site www.random.org/integres. Then a random sequence of numbers generated on the web will be recorded and the random allocation will be hidden by presenting a sealed envelope containing the treatment code to the participants.
Settings and conduct
Referrals to the Physical Medicine and Rehabilitation Clinic of Sadoughi Hospital in Yazd with a diagnosis of plantar fasciitis are placed in one of the treatment groups and are treated with therapeutic modality according to the group.
Participants/Inclusion and exclusion criteria
Age over 18 years and under 55 years, plantar fasciitis confirmed by physical and orthopedic specialists, failure to respond to conservative treatments including ice and rest and stretching and insole and NSAIDS after 1 week
Intervention groups
Group A: Stretching exercises, insole administration and shock wave
Group B Stretching exercises, insole administration and high power laser
Main outcome variables
Reduce pain and tenderness;Improve the quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210913052465N1
Registration date:2021-10-22, 1400/07/30
Registration timing:retrospective
Last update:2021-10-22, 1400/07/30
Update count:0
Registration date
2021-10-22, 1400/07/30
Registrant information
Name
Marzieh Zarebidoki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3253 2476
Email address
zarebidoki.ma@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-14, 1399/02/25
Expected recruitment end date
2020-10-23, 1399/08/02
Actual recruitment start date
2020-05-22, 1399/03/02
Actual recruitment end date
2020-12-26, 1399/10/06
Trial completion date
2021-03-27, 1400/01/07
Scientific title
Comparison of the High Intensity laser Therapy (HILT) with Extra corporeal Shock Wave Therapy (ESWT) in the treatment of patients with plantar fasciitis
Public title
Effect of high power laser in treatment of plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Plantar fasciitis confirmed by specialists in physical medicine and orthopedics
Failure to respond to conservative therapies including ice, rest, traction, insole, and NSAIDS after 6 weeks
Exclusion criteria:
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Online randomization sampling method will be used, which will be done using the site www.random.org/integres, then the random sequence of numbers generated on the web will be recorded and hiding the random assignment of participants to One of the two treatment groups will be performed. To hide the random allocation, the researcher chooses 28 envelopes for the high-power laser group and the same number for the extra corporal shock wave (ESWT) group, and the type of treatment is written inside these envelopes. And the generated codes are written in these envelopes. These envelopes are then handed over to the research colleagues who have no benefit from the research to give to the patients at random.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the participants did not know which group they were in
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid sadughi University of Medical School
Street address
Ebne Sina Alley,Yadregare emam Ave, Mazvirabad
City
Mehriz
Province
Yazd
Postal code
8981855515
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.017
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
Pain relief
Timepoint
Before treatment and two weeks after treatment and three months after
Method of measurement
Visual Analogue Scale
2
Description
Quality of life
Timepoint
Before and 3 months after
Method of measurement
36-item quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Radial shock wave modality, 3 weeks and 3 sessions in the week
Category
Treatment - Devices
2
Description
Intervention group: high level laser therapy modality , 3 weeks and 3 sessions in the week
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadooghi Hospital, Yazd
Full name of responsible person
Marzieh zare
Street address
Ebne Sina Ave, Shahid Ghandi Blvd, Safaieh
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
Zarebidoki.ma@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zare Marzieh
Street address
Ebne Sina Ave, Shahid Ghandi Blvd, Safaieh
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
Zarebidoki.ma@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Sadoughi University of Medical sciences
Proportion provided by this source
1
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
Yazd University of Medical Sciences
Full name of responsible person
Zare Marzieh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Ebne sina Alley, Yadegare Emam Ave, Mazvirabad
City
Mehriz
Province
Yazd
Postal code
8981855515
Phone
+98 35 3253 2476
Email
Zarebidoki.ma@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zare Marzieh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Ebne sina Alley, Yadegare Emam Ave, Mazvirabad
City
Mehriz
Province
Yazd
Postal code
8981855515
Phone
+98 35 3253 2476
Email
Zarebidoki.ma@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zare Marzieh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Ebne sina Alley, Yadegare Emam Ave, Mazvirabad
City
Mehriz
Province
Yazd
Postal code
8981855515
Phone
+98 35 3253 2476
Email
Zarebidoki.ma@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data
When the data will become available and for how long
Starting access period from 6 months after printing
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions who research related cases
From where data/document is obtainable
By sending a request to the email
zarebidoki.ma @gmail .com
What processes are involved for a request to access data/document
After sending the researcher's request to the e-mail along with providing documents regarding the verification of real and legal identity and confirmation of conducting research in the relevant field, information will be sent within three months.