Protocol summary

Study aim
Comparative study of myofascial release of lumbar spine muscles with lower limb muscle release on myofascial system parameters and performance in patients with chronic non-specific back pain.
Design
The study is a clinical trial with a control group, with parallel, double-blind, randomized groups. . People are divided into three groups by simple randomization method
Settings and conduct
Non-random sampling of people with non-specific chronic back pain referring to physiotherapy clinics was selected in a simple and accessible way, then after selecting the sample with entry and exit criteria, the participants were divided into three groups by simple randomization method.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study included people aged 18-45 who had non-specific chronic back pain that lasted more than 3 months and caused muscle involvement, and their VAS was less than 3, which means it was not an acute problem. Exclusion criteria: pregnancy, tumor Spinal cord, infection or fracture, infectious, vascular, endocrine, metabolic or neoplastic autoimmune disease, systemic disease, fibromyalgia, cauda equina syndrome, previous spine surgery or lower extremity musculoskeletal injuries, previous experience in myofascial therapy or history of rehabilitation therapy Do not have back pain in the past two months
Intervention groups
Individuals in the two intervention groups, a lumbar fascia release group and a lower extremity fascia release group, receive four sessions twice a week along with routine electrotherapy. In the control group, only routine electrotherapy is performed.
Main outcome variables
Muscle thickness, pain, disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160808029264N17
Registration date: 2024-05-18, 1403/02/29
Registration timing: prospective

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-31, 1403/06/10
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of lumbar spine muscles myofascial release with remote myofascial release of lower limb muscles on the ultrasonography parameters of myofascial system and function in patient with chronic nonspecific low back pain
Public title
the effect of fascia release in non-specific chronic back pain patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria for the study included people aged 18-45 who had non-specific chronic back pain that lasted for more than 3 months and caused muscle involvement and their VAS was less than 3, which means it was not an acute problem.
Exclusion criteria:
Pregnancy spinal cord tumor infection or fracture infectious, vascular, endocrine, metabolic or neoplastic autoimmune disease, systemic disease, fibromyalgia, cauda equina syndrome, previous spine surgery or lower extremity musculoskeletal injuries, previous experience in myofascial therapy or Do not have a history of rehabilitation treatment for back pain in the last two months
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a random table, the patient will be randomly assigned into the groups by choosing the number.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know which group they are in. The evaluator of study outcomes will also not know about the grouping of patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Comitee of Semnan University of Medical Sciences
Street address
Basij Blvd.,Semnan., Semnan Province
City
semnan
Province
Semnan
Postal code
99951-35198
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.SEMUMS.REC.1402.315

Health conditions studied

1

Description of health condition studied
non specific chronic low back pain
ICD-10 code
M54.06
ICD-10 code description
Panniculitis affecting regions of neck and back, lumbar region

Primary outcomes

1

Description
Muscle thickness
Timepoint
The first session and the last session
Method of measurement
sonography

2

Description
pain
Timepoint
The first session and the last session
Method of measurement
VAS

3

Description
disability
Timepoint
The first session and the last session
Method of measurement
The Quebec Back Pain Disability Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention groIntervention group: The interventions performed in this group include the release of spinal fascia such as quadratus lumborum, erector spinae, thoracolumbar fascia and soas for four sessions twice a week and each session thirty minutes of release on each side. Routine electrotherapy is also performed.
Category
Rehabilitation

2

Description
Intervention grouIntervention group: The interventions performed in this group include the release of lower limb fascia such as gastrocnemius, soleus, plantar fascia, and hamstring for four sessions twice a week and each session thirty minutes of release on each side. Routine electrotherapy is also performed.p:
Category
Rehabilitation

3

Description
Control group: routine electrotherapy is performed in this group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center,. Semnan University of Medical Scinces., Semnan., Iran.
Full name of responsible person
Dr Rasool Bagheri
Street address
Basij Blvd.,Semnan., Semnan Province
City
semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3336 4180
Email
rasool.bagheri@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
DrMajid Mirmohammadkhani
Street address
Basij Ave., Deputy of research and technology
City
semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan 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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mansourehrahbary
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Imam Ali Square, , Golestan Golshan St No91
City
semnan
Province
Semnan
Postal code
3519845358
Phone
+98 23 3334 45230
Email
mansourehrahbary@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
City
semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3344 1022
Email
rasool.bagheri@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasool Bagheri
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Km 5 Damghan Road., Semnan University of Medical Sciences., School of Rehabilitation., Semnan town
City
semnan
Province
Semnan
Postal code
3513135111
Phone
+98 23 3344 1022
Fax
+98 21 2222 0946
Email
rasool.bagheri@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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