The effects of myofascial release on stiffness of thoracolumbar fascia, cervical range of motion, neck disability index and cranio-vertebral angle in women with forward head posture
Assessing the effect of receiving 4 sessions of thoracolumbar release in treating forward posture in women. The effects of this treatment on thoracolumbar fascia stiffness ,craniovertebral angle, neck disability index & active neck range of motion will be assessed as well.
Design
Randomized, control, double-blinded trial with intervention ( exercise therapy & myofascial release) & control group( exercise therapy) of 40 patients. Block randomization was done by www.sealedenvelope.com.
Settings and conduct
after checking inclusion & exclusion criteria, candidates will be divided into intervention & control group whom will receive 2 sessions of treatment per week for 2 weeks. Immediately before first session & after last session of treatment assessment will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
all females with craniovertebral angle equivalent or less than 48 degrees
all females between 18-35 years old
Exclusion criteria: (history of surgery in spine/history of backache or neck pain in last 6 months/history of myelopathy or radiculopathy/history of whiplash injury/suffering from fibromyalgia/history of systematic disease/history of neuromuscular disease/ being a professional athlete/having red flags/being pregnant/suffering from headache or dizziness/not willing to finish treatment/start a new treatment for forward head posture/not finishing treatment sessions)
Intervention groups
The intervention group will receive exercise therapy and myofascial release while the control group will receive exercise therapy.
Main outcome variables
thoarcolumbar fascia's shear modulus-craniovertebral angle-neck disability index-neck active range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240307061208N1
Registration date:2024-08-05, 1403/05/15
Registration timing:registered_while_recruiting
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Fatemeh Saddeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 1733
Email address
fa-sadeghi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of myofascial release on stiffness of thoracolumbar fascia, cervical range of motion, neck disability index and cranio-vertebral angle in women with forward head posture
Public title
The effects of myofascial release on forward head posture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all females with craniovertebral angle equivalent or less than 48 degrees
all females between 18-35 years old
Exclusion criteria:
no history of surgery in spine
no history of backache or neck pain in last 6 months
no history of myelopathy or radiculopathy
no history of whiplash injury
not suffering from fibromyalgia
no history of systematic disease
no history of neuromuscular disease
not being a professional athlete
not having red flags
not pregnant
not suffering from headache or dizziness
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to either the control group (exercise therapy) or the
experimental group (exercise therapy + thoracolumbar fascia release) using block randomization method. A computerized random allocation sequence with 4 block sizes will be done using www.sealedenvelope.com website. Envelopes containing group allocations which will be written and opened by an uninvolved party.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted in a double-blind manner, in which the assessor and the participants will be blind to participants' group allocation. Envelopes containing participant group allocations will be written and opened by an uninvolved party.Thus, the assessor will be blind to grouping. Also, the participants will visit the clinic at certain intervals. As a result, they will not have a chance to talk to each other.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
N0 47, 19th Shahid-Hoseini street,Jahahn-Ara street, Yousef-Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1438914684
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.TUMS.FNM.REC.1402.161
Health conditions studied
1
Description of health condition studied
forward head posture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
This index explains the relationship between transverse stress & strain. Also this index is related to shear wave propagation in a homogenous system. Theoratically, shear modulus or tissue elasticity can be calculated by using shear wave speed which gives information about tissue's biomechanic quality.
Timepoint
in first session before intervention and in last session(fourth) after finishing intervention
Method of measurement
shear-wave elastography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran university of medical sciences
Full name of responsible person
Fateneh Sadeghi
Street address
Tehran university of medical sciences, Enghelab street, Tehran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 81613
Email
tumspr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Tehran university of medical sciences, Enghelab street, Tehran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 81613
Email
tumspr@tums.ac.ir
Web page address
https://tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadeghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 47, 19th street, Jahan-Ara, Yousef-Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1438914684
Phone
+98 21 8833 1733
Email
fatemehsadeghi333@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadeghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No47, 19th street, Jahan-Ara, Yousef-Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1438914684
Phone
+98 21 8833 1733
Email
fatemehsadeghi333@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadeghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No47, 19th street, Jahan-Ara, Yousef-Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1438914684
Phone
+98 21 8833 1733
Email
fatemehsadeghi333@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
The data files include demographic data and data collected from participants during assessment sessions
When the data will become available and for how long
Access to research data will be available after finishing and publishing the research
To whom data/document is available
medical universities researchers
Under which criteria data/document could be used
research and researcher certifications must be available
From where data/document is obtainable
Tehran university of medical sciences- rehabilitation faculty- Fatemeh Sadeghi
What processes are involved for a request to access data/document
After consulting with faculty professors, access to data will be available.