Virtual Reality Based Physical Therapy for Patients With Lower Back Pain

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare chronic low back patients. The main question[s] it aims to answer are: pain and disability fear avoidance belief Participants will perform virtual reality exercises virtual reality based exercises Routine Physical Therapy To Compare routine physical therapy treatment in addition to virtual reality to see effects on pain, functional disability and fear avoidance belief

Official Title
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Effects of Virtual Reality on Pain, Functional Disability and Fear Avoidance Belief in Patients With Chronic Low Back Pain

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Virtual reality Exercises
* Other: Routine Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low back pain that persists for more than 12 weeks Non-radiating low back pain Mechanical low back pain Both Gender Exclusion Criteria: trauma or fracture of the spine any cardiac disease any systematic disease history of any neurological diseases such as Parkinson's disease, stroke and epilepsy patient on corticosteroid or anticoagulants history of any Drug abuse any Congenital deformity Virtual reality games phobia Pregnant female

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality<br>virtual reality exercises will be administered along with routine physiotherapy | Other: Virtual reality Exercises<br>* Virtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises<br>|
| Active Comparator: Routine Physiotherapy (treatment as usual)<br>transcutaneous electrical nerve stimulation,Heat Therapy, Stretching and strengthening exercises with Cycling will be administered | Other: Routine Physiotherapy<br>* transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises<br>* Other names: treatment as usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain. | at baseline | 
| Functional disability | Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities. | at baseline | 
| Pain Intensity | The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain. | at 4th week | 
| Pain intensity | The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain. | at 8th week | 
| Functional Disability | Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities. | 4th week | 
| Functional Disability | Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities. | 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear avoidance belief | Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24) | at baseline | 
| Range of motion | Inclinometer (minimum range of motion zero and maximum 50). | Change in range of motion score will be measured at baseline, at 8th week | 
| Fear avoidance belief | Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24) | 4th week | 
| Fear avoidance belief | Fear avoidance belief questionnaire FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24) | 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, chronic low back pain, virtual reality