Protocol summary

Study aim
To compare the effects of myofascial release and ergon technique on foot function and balance in patients with planter fasciitis.
Design
It was a concealed, randomized, single blinded, sham controlled clinical trial with a parallel group design of 18 patients.
Settings and conduct
Study was conducted at Layyah city hospital of govt college university Faisalabad Layyah campus. The study population was consisted of patients with upper cross syndrome. The study was single blinded. The participants didn't know while they were receiving experimental or conventional treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30-50 years, both Gender, positive Windlass test, pain in the morning when taking the first steps or after prolonged rest, having unilateral resistant heel pain Exclusion criteria: Individuals with a history of trauma, any systemic illness, like rheumatism, arthritis, fracture below the knee during the preceding year, prior foot surgery, positive diagnosis of fat pad syndrome or tarsal tunnel syndrome were excluded
Intervention groups
Participants will be randomly allocated into two groups (Group A: MRT group, Group B: ergon technique group). The participants randomly allocated in Group A will be received myofascial release technique. Participants will execute this training after 15 minutes of ultrasound. This approach requires three sessions per week for six weeks. Group B participants will have received treatment includes ultrasound for 15 min and ergon technique.
Main outcome variables
Foot function (Foot Function Index), Balance (Berg Balance scale)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230731058990N3
Registration date: 2024-02-01, 1402/11/12
Registration timing: retrospective

Last update: 2024-02-01, 1402/11/12
Update count: 0
Registration date
2024-02-01, 1402/11/12
Registrant information
Name
Kashaf Faraz
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 304 6541357
Email address
kashaf.fraz@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-04, 1402/07/12
Expected recruitment end date
2023-10-24, 1402/08/02
Actual recruitment start date
2023-10-06, 1402/07/14
Actual recruitment end date
2023-10-28, 1402/08/06
Trial completion date
2023-11-15, 1402/08/24
Scientific title
Effects of myofascial release and ergon technique on foot function and balance in plantar fasciitis
Public title
Myofascial release and ergon technique effects in plantar fasciitis for foot function and balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-50 years Both Gender Positive Windlass test Pain in the morning when taking the first steps or after prolonged rest Having unilateral resistant heel pain
Exclusion criteria:
Individuals with a history of trauma A fracture below the knee during the preceding year Any systemic illness, like rheumatism, arthritis Prior foot surgery A positive diagnosis of fat pad syndrome or tarsal tunnel syndrome were excluded
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 26
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomized using gold fish bowl method into two groups, control and experimental. Treatment allocation were done by using concealed envelope method. In this, sealed opaque envelops with treatment regimen written were provided to the participants. Once a patient had consented to enter a trial room, an envelope was opened, and the patient was then offered the allocated treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single blinded. The participants did not know while they were receiving experimental or routine physical therapy treatment. and yes, intervention is similar enough for blinding participants.
Placebo
Not used
Assignment
Parallel
Other design features
Heel pain, Windlass test, Berg Balance Scale, Foot Function Index

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee (REC)
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Postal code
54000
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
REC-UOL-567-08-2023

Health conditions studied

1

Description of health condition studied
Plantar fasciitis
ICD-10 code
Plantar fa
ICD-10 code description
M72.2

Primary outcomes

1

Description
Foot Function
Timepoint
Baseline, 3rd week and 6th week of treatment
Method of measurement
Foot Function Index

2

Description
Balance
Timepoint
Baseline, 3rd week and 6th week of treatment
Method of measurement
Berg Balance Scale

Secondary outcomes

1

Description
Quality of Life
Timepoint
Baseline, 3rd and 6th week of treatment
Method of measurement
Short Form-12

Intervention groups

1

Description
Group A received routine physical therapy included ultrasound. Ultrasound will be used for 10 minutes (Frequency 3MHz) in each session. Total duration for each session with intervention will be 25-30 minutes. After baseline treatment, myofascial release technique was given according to the anatomy trains concept on the superficial back line of lower limb. The subjects are taken in supine position with Lower Limb extended and foot in Dorsiflexion. Myofascial release technique was given on the plantar surface. The technique was performed in three strokes directly over the patient’s skin by sliding the hand throughout the Dorsiflexion with constant pressure in the caudo-cranial direction
Category
Rehabilitation

2

Description
Group B received routine physical therapy included ultrasound. Ultrasound will be used for 10 minutes (Frequency 3MHz) in each session. Total duration for each session with intervention will be 25-30 minutes. After baseline treatment, Ergon technique has several different options for tools as well as treatment techniques. Now we use Graston tool while patient in prone position scan the tissue and point of fibrosis or any sort of restriction in gastrocnemius. Use the tool all the way down in sweeping motions feelings for restrictions from proximal to distal and from up to down at the junction of Achilles. Now ask the patient to do dorsiflexion while scooping Achilles tendon from insertion to origin.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Physical Therapy, DHQ Hospital Layyah
Full name of responsible person
Dr Khurram mahmood
Street address
DHQ Hospital Layyah
City
Layyah
Postal code
31200
Phone
+92 304 4407035
Email
mehmokhuram8@gmail.com
Web page address
https://dhqlayyah.punjab.gov.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
UOL, Lahore
Full name of responsible person
Dr Ashfaq Ahmad
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Postal code
54000
Phone
+92 344 4535304
Email
ashfaaqpt@gmail.com
Web page address
https://uol.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
UOL, 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
UOL, Lahore
Full name of responsible person
Dr Sania Naz
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 304 4407035
Email
sania.naz642@gmail.com
Web page address
https://uol.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
UOL, Lahore
Full name of responsible person
Dr Kashaf Faraz
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1-Km defense road Lahore, Pakistan
City
Layyah
Province
Punjab
Postal code
54000
Phone
+92 304 6541357
Email
kashaffraz@gmail.com
Web page address
https://uol.edu.pk/

Person responsible for updating data

Contact
Name of organization / entity
UOL, Lahore
Full name of responsible person
Dr Iqra Islam
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
1-Km defense road Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 313 4260161
Email
iqrawislam@gmail.com
Web page address
https://uol.edu.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
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
Demographic data and data related to final outcome will be shared by maintaining the confidentiality.
When the data will become available and for how long
Data will be available from April 2024 to June 2024 after the 6 months of publication. The data sharing plan for a clinical trial (i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's International Clinical Trials Registry Platform; this occur before the first participant is enrolled.
To whom data/document is available
Dr. Sania Naz (corresponding author) professor at UOL, Lahore.
Under which criteria data/document could be used
for research purpose
From where data/document is obtainable
To the corresponding author of the study, Dr Sania Naz and can contact on +923044407035 saaniaanaz@gmail.com can visit these search engines, you can find my study easily here https://www.researchgate.net/ https://scholar.google.com/
What processes are involved for a request to access data/document
Open-access and there is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by Director in Charge and in case of eligibility, it would be shared in two weeks
Comments
I want randomized clinical trial registration.
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