Protocol summary
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Study aim
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The purpose of study is to investigate of the effects of myofascial release techniques on clinical findings and electroencephalography activities in patients with nonspecific chronic low back pain
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Design
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Randomized, controlled, single blinded trial
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Settings and conduct
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50 patients with NSCLBP participate in this research in physiotherapy clinic of School of Rehabilitation, Tehran University of Medical Sciences. After the randomization, patients are placed in one of the intervention or control groups. Physiotherapist performs myofascial release techniques and trains therapeutic exercises for three times a week for three weeks. Then, patients are asked to complete the pain and disability questionnaire, and they evaluate lumbar active range of motion and brain signals before and after the intervention. Evaluation of variables is performed before intervention, at the end of each week and one month after the third week of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1-Male patients with an average age between 20-40 years old
2-History of bilateral or unilateral lumbar pain, between the margins of the ribs to the inferior gluteal fold, without referral or radicular pain to the lower limbs and without any obvious cause in the patient's history
3-History of low back pain for at least 3 months
4-A maximum pain score 4 from 10 with using a Visual Analogue Scale (VAS)
Exclusion criteria:
1-Inappropriate recording brain signals with electroencephalography
2-Unwillingness of subjects to continue testing
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Intervention groups
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There are two groups (Intervention group: myofascial release techniques with therapeutic exercises, and Control group: Only therapeutic exercises)
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Main outcome variables
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1-pain intensity
2-Functional disability index
3-Lumbar active flexion and extension range of motion
4-Brian signals and parameters
General information
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Reason for update
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Change recruitment dates
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Acronym
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MFR & CNSLBP
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IRCT registration information
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IRCT registration number:
IRCT20090301001722N24
Registration date:
2020-04-18, 1399/01/30
Registration timing:
prospective
Last update:
2020-05-08, 1399/02/19
Update count:
1
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Registration date
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2020-04-18, 1399/01/30
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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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2020-05-04, 1399/02/15
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Expected recruitment end date
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2020-11-20, 1399/08/30
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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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Investigation of the effects of myofascial release techniques on clinical findings and electroencephalography activities in patients with nonspecific chronic low back pain
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Public title
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effects of myofascial release techniques on patients with nonspecific chronic 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:
Male patients with an average age between 20-40 years old
A Body Mass Index (BMI) between 25 and 30
History of bilateral or unilateral lumbar pain, between the margins of the ribs to the inferior gluteal fold, without referral or radicular pain to the lower limbs and without any obvious cause in the patient's history
History of low back pain for at least 3 months
A maximum pain score 4 from 10 with using a Visual Analogue Scale (VAS)
Right-handed participants
Exclusion criteria:
Receiving physiotherapy programs (myofascial release, massage, therapeutic exercise, ...) two months ago
A previous surgery for spinal and abdominal area, shoulder and pelvic girdles, lower extremities
A previous history of medical diseases, and cardiovascular / respiratory diseases, neurological diseases
Previous postural problems or muscle shortening
A previous history of pain or disability in the upper and lower extremities
A previous history of infection or vertebral fractures, and fibromyalgia
A previous history of vestibular disordersو and balance and cognitive problems
Inappropriate recording brain signals with electroencephalography
Unwillingness of subjects to continue testing
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Age
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From 20 years old to 40 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients were randomly divided into three groups by closed envelope method. The allocation of the subjects will be concealed by using sequentially numbered, sealed and opaque envelopes. On the first day of treatment, the envelope allocated will be opened by participant.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Assessor Blind:
Data safety will be ensured by assigning Specific Identity numbers and all consent, readings forms will be placed in locker to bind Assessors
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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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2020-03-10, 1398/12/20
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.1020
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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Pain intensity
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Timepoint
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before intervention, after each intervention session, and After one month follow up
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Method of measurement
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Visual Analogue Scale (VAS)
2
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Description
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Pain intensity
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Timepoint
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before intervention, after three weeks, and After one month follow up
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Method of measurement
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Short Form McGill Pain Questionnaire
3
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Description
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Brian signals and parameters
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Timepoint
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before intervention, at the end of each week, and After one month follow up
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Method of measurement
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Electroencephalography
Secondary outcomes
1
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Description
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Functional disability index
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Timepoint
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before intervention, after three weeks, and After one month follow up
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Method of measurement
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Quebec Low Back Pain Disability Scale Questionnaire
2
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Description
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Functional disability index
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Timepoint
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before intervention, after three weeks, and After one month follow up
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Method of measurement
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The Oswestry Disability Questionnaire
3
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Description
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Lumbar active flexion and extension range of motion
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Timepoint
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before intervention, after each intervention session, and After one month follow up
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Method of measurement
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Inclinometer
Intervention groups
1
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Description
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Intervention group: myofascial release techniques with therapeutic exercises. These techniques are performed three times a week for three weeks by a physiotherapist. These techniques include unloading techniqes with low force and long duration for quadratus lumborum, psoas muscles, and thoracolumbar fascia.
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Category
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Rehabilitation
2
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Description
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Control group: Therapeutic exercises. These exercises are taught by a physiotherapist and performed for three weeks. These exercises include "single knee to chest", "double knee to chest", camel-cat, and knee rocking.
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Category
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Rehabilitation
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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Tehran University of Medical Sciences
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available