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“Comparison of extracorporeal shockwave and high intensity laser in reducing pain and improving function in chronic plantar fasciitis.”

Protocol summary

Study aim
By knowing the short and long term effects of ESWT(Extracorporeal shockwave therapy) and HILT(High intensity laser theray) in patients of chronic plantar fasciitis, we can avoid the need of cortisone injection and surgery.
Design
A randomized controlled not blind trial. Samples will be divided into 2 groups.1 group will be treated with extra corporeal shock wave and 2nd will be treated with high intensity LASER therapy. Both groups will receive treatment for 3 weeks and than follow up will be taken after 2 months.
Settings and conduct
Setting: LIfeline Healthcare and Pain center, Opposite Jinnah hospital Lahore, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: both genders, minimum age 18 and maximum 70, VAS >5 on first step in morning, Informed consent, Symptoms duration more than 6 months. Exclusion criteria: Previous surgery of plantar fasciitis, Pregnancy, Pacemaker fitted, Bleeding disorder, Any tumor of treatment site, calcaneous stress fracture checked by squeeze test.
Intervention groups
Patients will be randomly divided into two groups 15 subjects in each group. After taking baseline assessment Group 1 will be treated with BTL-6000 Shockwave therapy Intensity= 2.0 Bar, Frequency =10Hz, Number of Shocks=2000. The ESWT will be applied in a circular motion on the insertion site of the plantar fascia (1,000 shocks) and along the fascia (1,000 shocks). (9) twice a week for 3 weeks. Group 2 will receive Diowave 60W Class IV Laser three times per week for 3 weeks for a total of 9 sessions at wavelength of 980nm, a laser output of 30 Watts and energy dose of 10,000 Joules. Scanning method will be used. Both groups will be given some exercises to follow for home plan.
Main outcome variables
Pain (VAS) Function of foot by Foot functional Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200317046798N1
Registration date: 2020-04-17, 1399/01/29
Registration timing: prospective

Last update: 2020-04-17, 1399/01/29
Update count: 0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Saba Riaz
Name of organization / entity
Riphah International University Lahore, Pakistan
Country
Pakistan
Phone
+92 42 35225100
Email address
sabariaz317@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-10, 1399/02/21
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“Comparison of extracorporeal shockwave and high intensity laser in reducing pain and improving function in chronic plantar fasciitis.”
Public title
“Comparison of extracorporeal shockwave and high intensity laser in reducing pain and improving function in chronic plantar fasciitis.”
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders minimum age 18 and maximum 70 Visual analogue Scale >5 on first step in morning Informed consent Symptoms duration more than 6 months
Exclusion criteria:
Previous surgery of plantar fasciitis, Pregnancy Pacemaker fitted Bleeding disorder, Any tumor of treatment site calcaneous stress fracture checked by squeeze test
Age
From 18 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by lottery method. Allocation concealment through sealed envelops
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Non-probability convenient sampling technique will be used to recruit the individuals for the study and then randomization will be done by lottery method to divide the individuals into 2 treatment groups. Sealed envelops will be used for allocation concealment.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah College of Rehabilitation Sciences (RCRS) Research Ethical Committee (REC)
Street address
near Hajj Complex، I-14, Islamabad, Islamabad Capital Territory
City
Islamabaad
Postal code
46000
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
RCRS-RE-MS-OMPT/SPring 19/ 033

Health conditions studied

1

Description of health condition studied
Plantar Fasciitis is one of the most common causes of heel pain. It involves inflammation of a thick band of tissue that runs across the bottom of your foot and connects your heel bone to your toes
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis

Primary outcomes

1

Description
Pain
Timepoint
before treatment. than after treatment (3 weeks), Follow Up (after 2 months)
Method of measurement
Visual Analogue scale , Foot functional Index (Short version)

2

Description
Functional Status
Timepoint
before treatment. than after treatment (3 weeks), Follow Up (after 2 months)
Method of measurement
Foot functional Index (Short version)

Secondary outcomes

empty

Intervention groups

1

Description
After taking baseline assessment Group 1 will be treated with BTL-6000 Extracorporeal Shockwave therapy Intensity= 2.0 Bar, Frequency =10 Hz , Number of Shocks=2000. The ESWT will be applied in a circular motion on the insertion site of the plantar fascia (1,000 shocks) and along the fascia (1,000 shocks). twice a week for 3 weeks
Category
Treatment - Devices

2

Description
After taking baseline assessment group 2 will receive Diowave 60W Class IV Laser three times per week for 3 weeks for a total of 9 sessions at wavelength of 980 nm , a laser output of 30 Watts and energy dose of 10,000 Joules. Scanning method will be used.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Lifeline Health Care and Pain Center , opposite Jinnah hospital Lahore, Pakistan
Full name of responsible person
Saba Riaz
Street address
150-HBFC, Opp. Emergency Gate Jinnah Hospital,Lahore
City
Lahore
Postal code
54770
Phone
+92 42 35236690
Email
sabariaz317@gmail.com
Web page address
http://www.lifelinehealthcare.org/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lifeline Healthcare and pain center
Full name of responsible person
Saba Riaz
Street address
150-HBFC, opp Jinnah Hospital Emergency Gate, Lahore Pakistan
City
Lahore
Postal code
54770
Phone
+92 42 35225100
Email
sabariaz317@gmail.com
Web page address
http://www.lifelinehealthcare.org/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lifeline Healthcare and pain center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University Lahore, Pakistan
Full name of responsible person
Saba Riaz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House No: 124, Sector SW, NFC Society, Phase 1, Near Wapda Town Lahore, Pakistan.
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 35225100
Fax
Email
sabariaz317@gmail.com
Web page address
http://www.lifelinehealthcare.org/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
SABA RIAZ
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House No: 124, Sector SW, NFC society Phase 1, near Wapda town Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 35225100
Email
sabariaz317@gmail.com
Web page address
http://www.lifelinehealthcare.org/

Person responsible for updating data

Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
Saba Riaz
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no: 124, Sector SW, NFC society Phase 1, Near wapda Town Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 35225100
Email
sabariaz317@gmail.com
Web page address
http://www.lifelinehealthcare.org/

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
Yes - There is 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
study protocol, Statistical analysis, results
When the data will become available and for how long
after completion of study
To whom data/document is available
People working in Healthcare providing centers and academic institutes regarding healthcare.
Under which criteria data/document could be used
According to Profession
From where data/document is obtainable
Different search sites
What processes are involved for a request to access data/document
Registration on specific site
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