Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This study compares the effect of multidimensional physiotherapy to usual evidence-based physiotherapy in the treatment of chronic nonspecific low back pain in adults. Half of the participants will receive multidimensional physiotherapy based on biopsychosocial approach while the other half will receive usual evidence based physiotherapy.

Detailed Description
-----------------
multidimensional physiotherapy treatment include: psychoeducation based on cognitive behavioral therapy (CBT), education, graded exposure, postural correction exercise, lifestyle change, and electrotherapy. usual evidence-based physiotherapy include: electrotherapy, education, and trunk general exercises.

Official Title
-----------------
Effect of Multidimensional Physiotherapy Based on Biopsychosocial Approach on Clinical Findings and Electroencephalography (EEG) Spectrum in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

Conditions
-----------------
Low Back Pain, Mechanical

Intervention / Treatment
-----------------
* Other: Multidimensional physiotherapy
* Other: Usual physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-50 Low back pain for 3 months or more Disability based on Oswestry Disability Index (ODI) between 20-60 Fear of movement based on Tampa scale of kinesiophobia >37 Minimum level of education Native Persian speaking Exclusion Criteria: Any evidence of e specific medical diagnosis Rheumatoid disease,fibromyalgia, neuropathy, progressive neurological disease History of headache, dizziness, nausea, epilepsy, migraines and mental disorder Beck's Anxiety Inventory> 26 Beck's Depression Inventory II> 29 Pregnancy Having other therapies during the present research

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidimensional physiotherapy<br>Multidimensional physiotherapy based on biopsychosocial, twice a week, 12 sessions | Other: Multidimensional physiotherapy<br>* Multidimensional physiotherapy based on biopsychosocial approach<br>|
| Active Comparator: Usual physiotherapy<br>Usual evidence based physiotherapy, twice a week, 12 sessions | Other: Usual physiotherapy<br>* Usual evidence based physiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity(questionnaire): Numeric Rating Scale | Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain). | At baseline | 
| Change of Pain intensity (questionnaire): Numeric Rating Scale | Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain). | At 6 weeks, after 12 treatment sessions in 38 days | 
| Change of Pain intensity (questionnaire): Numeric Rating Scale | Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain). | At 1 month | 
| Change of Pain intensity(questionnaire): Numeric Rating Scale | Self reported pain intensity based on Numeric Rating Scale,that is composed of 0 (no pain at all) to 10 (worst imaginable pain). | At 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life assessment | Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability. | At baseline | 
| Fear Avoidance Believes | Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs. | At baseline | 
| Kinesiophobia | Self reported kinesiophobia based on Tampa scale of kinesiophobia. A higher score means more fear of movement. | At baseline | 
| Pain Catastrophizing | Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). | At baseline | 
| Disability | Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability. | At baseline | 
| Forward flexion range of motion (ROM) | Forward flexion ROM measure by meter | At baseline | 
| Brain function | Relative power and absolute power of the frequency spectrum of EEG | At baseline | 
| Change in Quality of Life | Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability. | At 6 weeks, after 12 treatment sessions in 38 days | 
| Change of Fear Avoidance Believes | Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs. | At 6 weeks, after 12 treatment sessions in 38 days | 
| Kinesiophobia | Change of Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement. | At 6 weeks, after 12 treatment sessions in 38 days | 
| Change of Pain Catastrophizing | Self reported pain Catastrophizing based on Pain Catastrophizing Scale | At 6 weeks, after 12 treatment sessions in 38 days | 
| Change of Disability | Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability. | At 6 weeks, after 12 treatment sessions in 38 days | 
| Change of Forward flexion range of motion (ROM) | Forward flexion ROM measure by meter | At 6 weeks, after 12 treatment sessions in 38 days | 
| Change of Brain function | Relative power and absolute power of the frequency spectrum of EEG | At 6 weeks, after 12 treatment sessions in 38 days | 
| Change of Quality of Life | Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability. | At 1 months | 
| Change of Fear Avoidance Believes | Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire. A higher score indicates more strongly held fear avoidance beliefs. | At 1 months | 
| Change of Kinesiophobia | Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement. | At 1 months | 
| Change of Pain Catastrophizing | Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). | At 1 months | 
| Change of Disability | Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability. | At 1 months | 
| Change of Forward flexion range of motion (ROM) | Forward flexion ROM measure by meter | At 1 months | 
| Change of Brain function | Relative power and absolute power of the frequency spectrum of EEG | At 1 months | 
| Change of Quality of Life | Self-reported quality of life based on health service (SF-36) questionnaire, the lower score the more disability and the higher score means the less disability. | At 4 months | 
| Change of Fear Avoidance Believes | Self reported Fear Avoidance Believes based on Fear Avoidance Believes questionnaire.A higher score indicates more strongly held fear avoidance beliefs. | At 4 months | 
| Change of Kinesiophobia | Self reported kinesiophobia based on Tampa scale of kinesiophobiaA higher score means more fear of movement. | At 4 months | 
| Change of Pain Catastrophizing | Self reported pain Catastrophizing based on Pain Catastrophizing Scale.The scale is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). | At 4 months | 
| Change of Disability | Self reported disability based on Oswestry disability scale Questionnaire. A higher number indicates a greater disability. | At 4 months | 
| Change of Forward flexion range of motion (ROM) | Forward flexion ROM measure by meter | At 4 months | 
| Change of Brain function | Relative power and absolute power of the frequency spectrum of EEG | At 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Disability, Pain catastrophising, Quality of life, Fear of movement, Chronic non specific low back pain