Protocol summary
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Study aim
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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
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Design
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The clinical trial has a control group with parallel groups. non-randomized and double blind on at least 30 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Due to the prevalence of the Covid 19 pandemic, the sampling date changed. Of course, in the previous registration, the date of the sampling was incorrectly registered before the date of the trial confirmation, which was corrected. Except for the date of sampling, the other recorded cases did not change.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200423047173N1
Registration date:
2020-10-16, 1399/07/25
Registration timing:
prospective
Last update:
2021-07-21, 1400/04/30
Update count:
1
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Registration date
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2020-10-16, 1399/07/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-21, 1399/09/01
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Expected recruitment end date
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2021-02-19, 1399/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of myofascial release on low back pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 35 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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).
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-07, 1398/07/15
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Ethics committee reference number
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IR.MODARES.REC.1398.126
Health conditions studied
1
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Description of health condition studied
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chronic non-specific low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Lumbar fascia elastic coefficient
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Timepoint
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The beginning of the study, the end of the second week, the end of the fourth week
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Method of measurement
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Ultrasound device
2
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Description
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Lumbar muscles elastic coefficient
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Timepoint
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The beginning of the study, the end of the second week, the end of the fourth week
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Method of measurement
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Ultrasound device
Secondary outcomes
1
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Description
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Cuff and hamstring muscle flexibility
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Timepoint
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The beginning of the study, the end of the second week, the end of the fourth week
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Method of measurement
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Goniameter
2
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Description
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Lumbar pain
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Timepoint
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The beginning of the study, the end of the second week, the end of the fourth week
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Method of measurement
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Visual analoge scale
3
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Description
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Pelvic rotation angle
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Timepoint
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The beginning of the study, the end of the second week, the end of the fourth week
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Method of measurement
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Inclinometer
4
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Description
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Lumbar flexion angle
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Timepoint
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The beginning of the study, the end of the second week, the end of the fourth week
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Method of measurement
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Flexible ruler
Intervention groups
1
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Description
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Intervention group 1: Myofascial release of lumbar region in patients with chronic nonspecific low back pain
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Category
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Diagnosis
2
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Description
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Intervention group 2: Myofascial release of posterior-superficial pathway of lower extremities in patients with chronic nonspecific low back pain
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Category
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Diagnosis
3
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Description
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Control group: Routine physiotherapy (ultrasound and tens) of the lumbar region in patients with nonspecific low back pain
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Category
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Diagnosis
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All potential data can be shared after unidentified individuals
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When the data will become available and for how long
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Access period starts 12 months after the results are published
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To whom data/document is available
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The data will be available only to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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In order to perform any kind of analysis on the data, coordination is required
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From where data/document is obtainable
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Send a message to the mentioned e-mail address, named Hassan Tamratash.
h.tamartash@modares.ac.ir
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What processes are involved for a request to access data/document
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After sending the message and making the necessary arrangements, the data will be sent for a maximum of one month.
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Comments
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