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IRCT20140810018754N11 IRCT 2020-01-17 Iran University of Medical Sciences effect of multidimensional treatment based on biopsychosocial approach in chronic non specific low back pain Effect of multidimensional physiotherapy treatment based on biopsychosocial approach on clinical findings and electroencephalography spectrum in chronic nonspecific low back pain: A Randomized Controlled Trial 2020-04-05 anticipated 70 Complete https://irct.ir/trial/44373 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized to either active control or experimental group (1:1 ratio) using a stratified block allocation with stratification factors being gender (male or female). Then Randomization will be done by an independent investigator and will be concealed from patients and the other investigators, Blinding description: In this study, participants in each group did not meet each other in the waiting rooms (no contamination). The outcome assessor will not be aware of the grouping of patients. N/A non-specific chronic low back pain. Intervention 1: Patients in the intervention group will be received multidimensional treatment include psychoeducation based on cognitive behavioral therapy (CBT), education, graded exposure, postural correction exercise, Lifestyle change, and electrotherapy. Twelve 30 minute psycho-education sessions consist of the following sessions: Psychoeducation on Pain and Targeting (3 sessions), Anxiety Management, Interpersonal Conflict Management, Problem Solving Training, Training Coping strategy, Managing pain recurrent, preventing unnecessary medication use, enhancing one's ability to cope with labeling and stigma, empowering one to create a daily sleep routine, training relaxation techniques. Patients will also receive recommendations for lifestyle modifications, such as encouraging active living and a gradual increase in activity levels, improving the work environment, and training on how to perform daily and work activities correctly. Other treatments include postural correction and training of the necessary exercises, as well as the gradual initiation of movements and activities that the patient is afraid to perform. By asking the patient to perform hierarchical activities that he or she fears. The first step is to identify the movements that the patient is afraid of. The exercise begins with a movement that the patient has the least fear of, and that movement begins with the simplest state and the lowest level with the patient least feared, and gradually becomes more difficult. All of these are taught to the patient in each practice session. The patient is also asked to repeat the practice of each session at home once a day. Electrotherapy, including 20 minutes of skin electrical nerve stimulation (TENS) at 100 Hz in the lumbar region where the patient reports the most pain. The intensity of TENS is regulated by the patient. Surface heat will be placed in the lumbar area by Hot Pack at the same time as TENS. Ultrasound with a frequency of 1 MHz and intensity of 1.2 W/cm2 will be performed using a 5 cm square applicator on the paravertebral muscle where the patient reports the most pain, for 5 minutes. The treatment in this group is twelve sessions and will be performed twice a week. Intervention 2: Patients in the active control group, treatment will include electrotherapy, education, and trunk general exercises. Education in this group includes an explanation of the basic biomechanical anatomy of the spine, common causes of spinal pain, pain processing, ergonomic advice on how to perform daily activities and postures (such as sitting, standing, moving objects, etc.) and training for postural correction exercises. General Trunk Exercise will focus on abdominal and paraspinal muscles to improve blood flow, mobility, strength, and endurance in each session, and the patient will be asked to perform exercises in each session. The intensity and type of exercise will progress toward functional training. The patient is also asked to do exercise at home once a day. Electrotherapy, including 20 minutes of skin electrical nerve stimulation (TENS) at 100 Hz in the lumbar region where the patient reports the most pain. The intensity of TENS is regulated by the patient. Surface heat will be placed in the lumbar area by Hot Pack at the same time as TENS. Ultrasound with a frequency of 1 MHz and intensity of 1.2 W/cm2 will be performed using a 5 cm square applicator on the paravertebral muscle where the patient reports the most pain, for 5 minutes. The treatment in this group is twelve sessions and will be performed twice a week. Yes - There is a plan to make this available What will be shared: All data or results of the present study will be presented in an article or some articles that will be published after completing the study. When: After completing the present study and publishing the resulting article or articles To whom: All researchers in the field of the present study Conditions: With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences. Where to obtain: The corresponding author of the article or articles derived from this study How to obtain: Written request from the author responsible for the present review after the publication of the resulting article or articles Comments:
public Javad Sarrafzadeh
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences scientific Javad Sarrafzadeh
Mirdamad Ave., Madar squ., Shahnazari st., Madadkaran st.
Tehran Iran (Islamic Republic of) 1545913487 00982122228051-00982122227124 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age between 18-50 Permanent or intermittent local pain between L1 to gluteal fold without any radicular pain for 3 months or more and between 3-7/10 based on Numeric Rating Scale (NRS) Disability based on Oswestry Disability Index (ODI) between 20-60 Fear of movement based on Tampa scale for kinesiophobia>37 Minimum level of education Native Persian speaking 18 years 50 years Both Any evidence of e specific medical diagnosis include spondylolisthesis, fracture, tumor or inflammation disease Rheumatoid disease,fibromyalgia, neuropathy, Progressive neurological disease History of headache, dizziness, nausea, epilepsy, migraines and mental disorders History of lumbar surgery in the past 3 years Beck’s Anxiety Inventory> 26 Beck's Depression Inventory II> 29 Pregnancy Having other therapies during the present research M54.5 Low back pain Rehabilitation Rehabilitation Patients in the intervention group will be received multidimensional treatment include psychoeducation based on cognitive behavioral therapy (CBT), education, graded exposure, postural correction exercise, Lifestyle change, and electrotherapy. Twelve 30 minute psycho-education sessions consist of the following sessions: Psychoeducation on Pain and Targeting (3 sessions), Anxiety Management, Interpersonal Conflict Management, Problem Solving Training, Training Coping strategy, Managing pain recurrent, preventing unnecessary medication use, enhancing one's ability to cope with labeling and stigma, empowering one to create a daily sleep routine, training relaxation techniques. Patients will also receive recommendations for lifestyle modifications, such as encouraging active living and a gradual increase in activity levels, improving the work environment, and training on how to perform daily and work activities correctly. Other treatments include postural correction and training of the necessary exercises, as well as the gradual initiation of movements and activities that the patient is afraid to perform. By asking the patient to perform hierarchical activities that he or she fears. The first step is to identify the movements that the patient is afraid of. The exercise begins with a movement that the patient has the least fear of, and that movement begins with the simplest state and the lowest level with the patient least feared, and gradually becomes more difficult. All of these are taught to the patient in each practice session. The patient is also asked to repeat the practice of each session at home once a day. Electrotherapy, including 20 minutes of skin electrical nerve stimulation (TENS) at 100 Hz in the lumbar region where the patient reports the most pain. The intensity of TENS is regulated by the patient. Surface heat will be placed in the lumbar area by Hot Pack at the same time as TENS. Ultrasound with a frequency of 1 MHz and intensity of 1.2 W/cm2 will be performed using a 5 cm square applicator on the paravertebral muscle where the patient reports the most pain, for 5 minutes. The treatment in this group is twelve sessions and will be performed twice a week. Patients in the active control group, treatment will include electrotherapy, education, and trunk general exercises. Education in this group includes an explanation of the basic biomechanical anatomy of the spine, common causes of spinal pain, pain processing, ergonomic advice on how to perform daily activities and postures (such as sitting, standing, moving objects, etc.) and training for postural correction exercises. General Trunk Exercise will focus on abdominal and paraspinal muscles to improve blood flow, mobility, strength, and endurance in each session, and the patient will be asked to perform exercises in each session. The intensity and type of exercise will progress toward functional training. The patient is also asked to do exercise at home once a day. Electrotherapy, including 20 minutes of skin electrical nerve stimulation (TENS) at 100 Hz in the lumbar region where the patient reports the most pain. The intensity of TENS is regulated by the patient. Surface heat will be placed in the lumbar area by Hot Pack at the same time as TENS. Ultrasound with a frequency of 1 MHz and intensity of 1.2 W/cm2 will be performed using a 5 cm square applicator on the paravertebral muscle where the patient reports the most pain, for 5 minutes. The treatment in this group is twelve sessions and will be performed twice a week. Pain. Timepoint: Before the study, end of 6 weeks of treatment, 1 and 4 months follow-up. Method of measurement: Numeric Rating Scale. Quality of Life. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Sf36 questionnaire. Fear Avoidance Believes. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Fear Avoidance Believes questionnaire. Kinesiophobia. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Tampa scale of kinesiophobia. Pain Catastrophizing. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Pain Catastrophizing Scale. Disability. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Oswestry disability scalequestionnaire. Forward flexion ROM. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Tape. Absolute power of frequency spectrum. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Electroencephalography. Relative power of the frequency spectrum. Timepoint: Before study, end of 6 weeks treatment, 1 and 4 months follow-up. Method of measurement: Electroencephalography. Iran University of Medical Sciences Approved 2020-01-14 Ethics committee of Iran University of Medical Sciences 5th floor, Iran University of Medical Sciences, Hemmat highway, between Sheikh Fazlollah Nuri and Chamran highways Tehran Tehran Iran (Islamic Republic of)