Effect of Instrument Assisted Soft Tissue Mobilization Ergon Technique on Pain, Strength and Range of Motion in Plantar Fasciitis Patients: A Randomized Controlled Trial.
To compare the effects of Ergon Therapy with Routine physical therapy treatment
(cryotherapy, ultrasound therapy and stretching exercises) in treating plantar fasciitis.
Design
A single blinded randomized controlled trial study will be carried out on patients having Planter fasciitis. Patients will be recruited from Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore and Citi hospital Lahore. They will be assessed on selection criteria and eligible participants will be randomly allocated into two groups, using sealed enveloped method. Patients will be treated three times a week for total 5 weeks. After allocation in groups, participants will be assessed at baseline. Afterwards data will be collected at 1st-week intervals then 3rd week until the conclusion of 5th-week of interventions. All assessments will be performed by the same assessor at all stages of data collection for all patients.
Settings and conduct
Physical Therapy Department of University of Lahore teaching hospital, Citi hospital Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Diagnosed patients of plantar fasciitis.
• Age more than 18 years and less than 40 and Both genders.
• Connective tissue disorders (Osteoarthritis, Rheumatoid arthritis, Osteoporosis, Fibromyalgia).
Exclusion Criteria:
• History of previous surgical treatment or cancer of the heel
• Foot and/or ankle fracture
Congenital deformity
Intervention groups
Group A will be treated with routine physiotherapy program
Group B will be treated with routine physiotherapy program combined with Ergon technique
Main outcome variables
Visual Analogue Scale, Manual muscle testing and Goniometer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210816052201N2
Registration date:2021-10-11, 1400/07/19
Registration timing:retrospective
Last update:2021-10-11, 1400/07/19
Update count:0
Registration date
2021-10-11, 1400/07/19
Registrant information
Name
Sana Akram
Name of organization / entity
The University of Lahore, Lahore Pakistan
Country
Pakistan
Phone
+92 42 35183083
Email address
sana.akram@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-01, 1399/12/11
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
2021-03-13, 1399/12/23
Actual recruitment end date
2021-07-15, 1400/04/24
Trial completion date
2021-11-25, 1400/09/04
Scientific title
Effect of Instrument Assisted Soft Tissue Mobilization Ergon Technique on Pain, Strength and Range of Motion in Plantar Fasciitis Patients: A Randomized Controlled Trial.
Public title
Effect of Instrument Assisted Soft Tissue Mobilization Ergon Technique on Pain, Strength and Range of Motion in Plantar Fasciitis Patients: A Randomized Controlled Trial.
History of previous surgical treatment or cancer of the heel
Foot and/or ankle fracture
Congenital deformity
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated in two treatment groups by computer generated table number. After randomization, opaque sealed envelope will be offered to the patients. Once a patient has consented to enter a trial, an envelope is opened by clinician and treatment will be provided according to the group mention on the envelope.
Group A will be treated with routine physiotherapy program
Group B will be treated with routine physiotherapy program combined with Ergon technique .
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessor will be blinded by hiding the identity of patients. The patients will be trained not to give any hint about their allocation and their treatment groups. Blinding will be assessed by asking the assessor(force choice) to tell about patient group and a significant test will be used to see if there is a substantial chance that the assessor know about patient group identity for this p-value less than .05 will be used as significant value.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Lahore(Institutional Review Board)
Street address
The University of Lahore
City
Lahore
Postal code
54000
Approval date
2021-02-25, 1399/12/07
Ethics committee reference number
822
Health conditions studied
1
Description of health condition studied
Planter Fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Primary outcome variables are pain, range of motion and strength
Timepoint
Patients will be recruited from Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore and Citi hospital Lahore. They will be assessed on selection criteria and eligible participants will be randomly allocated into two groups, using sealed enveloped method. Patients will be treated three times a week for total 5 weeks. After allocation in groups, participants will be assessed at baseline. Afterwards data will be collected at 1st-week intervals then 3rd week until the conclusion of 5th-week of interventions. All assessments will be performed by the same assessor at all stages of data collection for all patients
Method of measurement
Visual Analogue Scale (VAS):It is used in clinical research to measure the intensity or frequency of Pain. Universal Goniometer: An instrument which measures the available range of motion (ROM) at a joint. Strength: Manual Muscle Testing is the most commonly used method for documenting impairments in muscle strength.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive instrument assisted soft tissue mobilization technique for fifteen minutes using ergon tools and conventional treatment including cryotherapy (10 minutes), ultrasound therapy (10 minutes) and Planter fascia stretching exercises (10 minutes), total time (45minutes/session). The Ergon with Conventional Therapy group will treated with 3 sessions per week.
Category
Treatment - Other
2
Description
Control group: will receive conventional treatment including cryotherapy (10 minutes), ultrasound therapy (10 minutes) and Planter fascia stretching exercises (10 minutes), total time (30minutes/session).The conventional group will also treated with 3 session per week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Lahore teaching hospital
Full name of responsible person
Sana Akram
Street address
The University of Lahore
City
Lahore
Postal code
54000
Phone
+92 42 31083083
Email
sana.akrampt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Professor Dr. Ashfaq Ahmed
Street address
The University of Lahore
City
Lahore
Postal code
54000
Phone
+92 42 31083083
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore, Lahore Pakistan
Full name of responsible person
Asim Arif
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35183083
Fax
Email
asim.arif@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore, Lahore Pakistan
Full name of responsible person
Asim Arif
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35183083
Fax
Email
asim.arif@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Khadija Nadeem
Position
Physical therapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35183083
Email
pptm02191011@student.uol.eu.pk
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effect of Instrument Assisted Soft Tissue Mobilization Ergon Technique on Pain, Strength and Range of Motion in Plantar Fasciitis Patients: A Randomized Controlled Trial.
When the data will become available and for how long
After publication of article the data will be available
To whom data/document is available
The data will be available to all kinds of Academic researchers
Under which criteria data/document could be used
A request can be processed by the study sponsor or by a delegate of the sponsor (e.g., an academic institution).
From where data/document is obtainable
Applicant must contact cores ponder of a research through email address
What processes are involved for a request to access data/document
Applicant must contact cores ponder of a research through email address
Comments
I am very thankful to Iranian trial registry team for making steps brief and to the point for registration