The effect of myofascial chain release on clinical symptoms, gastrocnemius muscle stiffness and plantar fascia thickness and stiffness in patients with chronic plantar fasciitis
1- The effect of myofascial release on gastrocnemius muscle on Young elastic modulus of plantar fascia and gastrocnemius muscle in patients with chronic plantar fasciitis
2- The effect of myofascial chain release (plantar fascia and gastrocnemius and hamstring muscles) on Young elastic modulus of plantar fascia and gastrocnemius muscle in patients with chronic plantar fasciitis
3- Comparison of the effect of myofascial chain release and myofascial release on the results of VAS and FAAM questionnaires in patients with chronic plantar fasciitis
4- Comparison of the effect of myofascial chain release and myofascial release on Young elastic modulus in plantar fascia and gastrocnemius muscle in patients with chronic plantar fasciitis
Design
randomized controlled trial, parallel group trial, single blinded, randomized, phase 3 on 30 patients, balloting will be used for randomization.
Settings and conduct
This study will be performed in the physiotherapy department of the Rehabilitation Faculty of Iran University of Medical Sciences. Patients will be divided into experimental group (release on plantar fascia, gastrocnemius muscle and hamstrings) and control group (release on gastrocnemius). This study will be of the one-blind (patient) type.
Participants/Inclusion and exclusion criteria
1- Pain at the site of attachment of the plantar fascia to the medial tubercle of the calcaneus
2- Increased pain in the initial steps in the morning or after a long rest
3- More than 3 months have passed since the onset of pain
Intervention groups
In the intervention group, myofascial release on plantar fascia, gastrocnemius and hamstring muscle will be used. In the control group, this technique will be used only on the gastrocnemius muscle.
Main outcome variables
young's modulus of plantar fascia
young's modulus of medial gastrocnemius
young's modulus of lateral gastrocnemius
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211006052686N1
Registration date:2022-01-05, 1400/10/15
Registration timing:registered_while_recruiting
Last update:2022-01-05, 1400/10/15
Update count:0
Registration date
2022-01-05, 1400/10/15
Registrant information
Name
seyed mehdi mohsenipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4490 1637
Email address
mohsenipour.sm@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of myofascial chain release on clinical symptoms, gastrocnemius muscle stiffness and plantar fascia thickness and stiffness in patients with chronic plantar fasciitis
Public title
The effect of myofascial chain release in patients with chronic plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pain over the origin of plantar fascia near medial tubercle of calcaneus bone
first steps pain in the morning or after prolonged rest
More than 3 months have passed since the onset of pain
35 to 60 years
the degree pf pain is between 3-7 on the VAS scale
Exclusion criteria:
History of orthopedic surgery in the lower extremities
Having diabetes and other underlying diseases affecting connective tissue
Perform injection, shock wave therapy and physiotherapy in the last 3 months
Contraindications for the treatment of myofascial release
Unwillingness to continue treatment
Age
From 35 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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
simple random sampling by sealed envelope - The control group is written in one envelope and the intervention group is written in the other envelope. The patient chooses one of them without knowing the contents of the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient receives the type of intervention in sealed envelopes.
The data analyser and the safety committee are unaware of the type of intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Rehabilitation Faculty of Iran University of Medical Sciences, Madadkaran Ave, Shahnazari St, Madar Sq, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Approval date
2021-11-06, 1400/08/15
Ethics committee reference number
IR.IUMS.REC.1400.713
Health conditions studied
1
Description of health condition studied
Plantar Fasciitis
ICD-10 code
M72. 2
ICD-10 code description
A superficial fibromatosis arising from soft tissue of the plantar regions. It is characterized by the presence of spindle-shaped fibroblasts, hypercellularity, and an infiltrative growth pattern.An inflammation of the plantar fascia, the tissue along the
Primary outcomes
1
Description
young's modulus of plantar fascia
Timepoint
before intervention - 2 or 3 days after intervention
Method of measurement
compressive sonoelastography
2
Description
young's modulus of medial gastrocnemius
Timepoint
before intervention - 2 or 3 days after intervention
Method of measurement
compressive sonoelastography
3
Description
young's modulus of lateral gastrocnemius
Timepoint
before intervention - 2 or 3 days after intervention
Method of measurement
compressive sonoelastography
Secondary outcomes
1
Description
plantar fascia thickness
Timepoint
before intervention - 2 or 3 days after intervention
Method of measurement
sonography
2
Description
pain intensity
Timepoint
before intervention - 2 or 3 days after intervention
Method of measurement
numeric pain rating scale
3
Description
functional assessment
Timepoint
before intervention - 2 or 3 days after intervention
Method of measurement
FAAM Questionare
Intervention groups
1
Description
Intervention group: myofascial chain release in hamstring and gastrocnemius muscle and plantar fascia
Category
Treatment - Other
2
Description
Control group: myofascial release in gastrocnemius mucsle
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy clinic of Rehabilitation Faculty of Iran University of Medical Sciences
Full name of responsible person
Ali Amiri
Street address
Shahnazari Ave - Madadkaran St
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 2059
Email
rehab@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Amiri
Street address
Shahnazari Ave - Madadkaran St
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 2059
Email
rehab@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyed mehdi Mohsenipour
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
3th Floor, No 32, Phase 6, Tehran University Town, Lashgari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1389938311
Phone
+98 21 4490 1637
Fax
Email
mohsenipour.sm@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed mehdi Mohsenipour
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
3th Floor, No 32, Phase 6, Tehran University Town, Lashgari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1389938311
Phone
+98 21 4490 1637
Fax
Email
mohsenipour.sm@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed mehdi Mohsenipour
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
3th Floor, No 32, Phase 6, Tehran University Town, Lashgari Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1389938311
Phone
+98 21 4490 1637
Fax
Email
mohsenipour.sm@iums.ac.ir
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
All data can be shared
When the data will become available and for how long
6 months after publication of the results
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
In order to use the results of this research to design future studies
From where data/document is obtainable
The applicant can send email with these addresses: mohsenipour.sm@iums.ac.ir or mohsenipour@hotmail.com.
What processes are involved for a request to access data/document
The application will be submitted to the physiotherapy department of the Rehabilitation Faculty and will be sent to the applicant after the approval of the supervisor and the department manager.