Comparative study of the effect of lumbar and lower limbs posterior superficial backline myofascial release on elastic coefficient, thickness and pain in non-specific chronic low back pain patients
Comparative study of myofascial release of lumbar region and posterior-superficial pathway of lower extremity myofacia on pain, elastic coefficient and fascia thickness of lumbar region in patients with chronic non-specific low back pain
Design
The clinical trial has a control group with parallel groups. non-randomized and double blind on at least 30 patients
Settings and conduct
The study place is Tarbiat Modares University. After the examinations to enter the study, participants are divided into three groups and at the end of interventions, They undergo an ultrasound by someone who is blind of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with chronic non-specific low back pain with at least 12 months of history of low back pain, shortness of the lumbar fascia and lower extremities, pain score between 4 and 6 on the VAS scale, age range 35 to 50, BMI is between 18.5 and 30.
People who have a history of disease and deformity of the spine and lower extremities, a history of underlying diseases such as rheumatic diseases, heart disease, etc. do not qualify for the study. Attendees are excluded from the study if they engage in strenuous activity, pregnancy, and unwillingness to continue.
Intervention groups
The intervention group includes patients with chronic nonspecific low back pain who receive myofascial lumbar relief intervention.
The intervention group includes patients with chronic nonspecific low back pain who receive myofascial intervention for lower extremity fascia.
The control group includes patients with chronic nonspecific low back pain who receive routine physiotherapy.
Main outcome variables
pain changes; Lumbar and lower extremity flexibility changes; Changes in the range of motion of lumbar and lower limbs; Changes in the elastic coefficient of myofascial lumbar tissue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200423047173N1
Registration date:2020-10-16, 1399/07/25
Registration timing:registered_while_recruiting
Last update:2020-10-16, 1399/07/25
Update count:1
Registration date
2020-10-16, 1399/07/25
Registrant information
Name
Hassan Tamartash
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3819
Email address
h.tamartash@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of lumbar and lower limbs posterior superficial backline myofascial release on elastic coefficient, thickness and pain in non-specific chronic low back pain patients
Public title
Effect of myofascial release on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with chronic nonspecific low back pain with a history of at least 12 months of low back pain.
Shortness in lumbar myofascial and posterior-superficial pathway of lower extremity myofascia.
Having a pain score between 4 and 6 on the VAS pain scale
Body mass index between 18.5 and 30.
Exclusion criteria:
History of spine and lower limb surgery
Existence of major deformities in the spine such as: scoliosis, kyphosis, etc.
Infection and history of rheumatic, infectious, cardiovascular diseases, etc.
Psychopathy
Disorders of the vestibular and visual systems.
Taking corticosteroids and history of lumbar injections (oral or steroid injections).
Pregnancy
Perform intense physical activity during the study.
Inability and unwillingness to continue study.
Age
From 35 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, patients (in two groups of myofascial lumbar and lower limb release) and co-evaluator who performs ultrasound before and after the intervention, will be unaware of the patient's exposure (myofascial lumbar or lower limb).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran
City
Tehran
Province
Tehran
Postal code
4115-111
Approval date
2019-10-07, 1398/07/15
Ethics committee reference number
IR.MODARES.REC.1398.126
Health conditions studied
1
Description of health condition studied
chronic non-specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Lumbar fascia elastic coefficient
Timepoint
The beginning of the study, the end of the second week, the end of the fourth week
Method of measurement
Ultrasound device
2
Description
Lumbar muscles elastic coefficient
Timepoint
The beginning of the study, the end of the second week, the end of the fourth week
Method of measurement
Ultrasound device
Secondary outcomes
1
Description
Cuff and hamstring muscle flexibility
Timepoint
The beginning of the study, the end of the second week, the end of the fourth week
Method of measurement
Goniameter
2
Description
Lumbar pain
Timepoint
The beginning of the study, the end of the second week, the end of the fourth week
Method of measurement
Visual analoge scale
3
Description
Pelvic rotation angle
Timepoint
The beginning of the study, the end of the second week, the end of the fourth week
Method of measurement
Inclinometer
4
Description
Lumbar flexion angle
Timepoint
The beginning of the study, the end of the second week, the end of the fourth week
Method of measurement
Flexible ruler
Intervention groups
1
Description
Intervention group 1: Myofascial release of lumbar region in patients with chronic nonspecific low back pain
Category
Diagnosis
2
Description
Intervention group 2: Myofascial release of posterior-superficial pathway of lower extremities in patients with chronic nonspecific low back pain
Category
Diagnosis
3
Description
Control group: Routine physiotherapy (ultrasound and tens) of the lumbar region in patients with nonspecific low back pain
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Araz Physiotherapy Clinic
Full name of responsible person
Hassan Tamartash
Street address
No. 120, Unit 9, Mirzababaei St., Punak, Tehran
City
Tehran
Province
Tehran
Postal code
1476773313
Phone
+98 21 4489 2775
Email
h.tamartash@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
farid Bahrpeyma
Street address
Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3819
Email
BAHRPEYF@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Hassan Tamartash
Position
Phd candidate student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3819
Fax
Email
h.tamartash@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Hassan Tamartash
Position
Phd candidate student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3819
Fax
Email
h.tamartash@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Hassan Tamartash
Position
Phd candidate student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Post Cod:14115-111, Nasr Bridge, Jalal Al Ahmd Ave, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3819
Fax
Email
h.tamartash@modares.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
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
All potential data can be shared after unidentified individuals
When the data will become available and for how long
Access period starts 12 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to perform any kind of analysis on the data, coordination is required
From where data/document is obtainable
Send a message to the mentioned e-mail address, named Hassan Tamratash.
h.tamartash@modares.ac.ir
What processes are involved for a request to access data/document
After sending the message and making the necessary arrangements, the data will be sent for a maximum of one month.