Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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Chronic low back pain and sciatica in adults represent a major medical and economic problem. During the chronic back pain (persisting continuously over 3 months), therapeutic responses to conventional pharmacologic type are often ineffective and the impact of pain is often heavy in terms of disability, social and professional avulsion and loss of quality of life. This failure has led in recent years to propose innovative strategies such as application of relaxation therapy techniques. An example is a virtual reality which is a technology to immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion combined with virtual reality can be effective on chronic pain. The main purpose is to measure the impact on the intensity of pain at 4 months after using of a new method for virtual environment, mimicking the colors from low to high frequencies (World Patent Filed, WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to therapeutic drugs.

Detailed Description
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Secondary objectives: Quantifying the effects in terms of disability associated with chronic pain Quantifying the effects on the cognitive (affect, anxiety, depression). Study the correlation between pain and oxidative stress. Methods :a controlled, randomized single-center prospective trial, according to a ZELEN modified scheme Intervention treatment : Pain treatment by a process of Virtual Reality 3D. The intervention protocol consists of 3 sessions of immersion in a 3D environment of 17 minutes per week for 4 consecutive weeks. Conducting the study: an inclusion visit, then the intervention protocol for patients in the arm Virtual Reality during 4 weeks, and then a monthly follow-up visit for 4 months. V0 - Inclusion Visit Physical examination Verification of eligibility Proposal of the trial cohort and collection of the informed consent, signed Inclusion Pain Numeric Scale Quebec questionnaire HAD questionnaire Blood samples for laboratory tests Randomization Proposal of the trial of virtual reality and collection of the informed consent, signed Intervention protocol for patients randomized to Arm virtual reality: Duration: 4 weeks 3 sessions per week of virtual reality (17 minutes of immersion and 15 minutes of rest) At each session: monitoring of heart rate during periods of rest and immersion) and control of blood pressure at the beginning and end of session. M1 - 1 Month Visit Physical examination Pain Numeric Scale Quebec questionnaire HAD questionnaire Blood samples for laboratory tests M2 - 2 Month Visit Pain Numeric Scale Quebec questionnaire M3 - 3 Month Visit Pain Numeric Scale Quebec questionnaire M4 - 4 Month Visit Pain Numeric Scale Quebec questionnaire HAD questionnaire

Official Title
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Evaluation of the Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain. A Randomized Controlled Trial Using a Modified ZELEN Method

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Virtual reality
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 and less than 60 years (inclusive) Chronic low back pain or chronic sciatica (between 3 months and 1 year of the current episode), without neurological deficit (low back pain more important than sciatica), common spinal origin, resistant to medical therapy, and the numerical pain scale > 30/100 Written informed consent Membership or beneficiary of an insurance Exclusion Criteria: Low back pain related to a spinal infectious disease, inflammatory, neoplasia, osteodystrophic, malformative and traumatic. Deficit sciatica (motor weakness and / or sensory) Low back pain secondary to failure of spinal intervention. Co-existence of pain of another etiology. Seizures. Psychiatric disorder, uncontrolled. Visual disturbances (significant decrease in visual acuity without correction possibility, problems with re-cognition of color, visual field loss). Inclusion in another trial to evaluate new ways of treating pain Sick leave over 1 year Pregnant women Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality<br> | Procedure: Virtual reality<br>* 3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks<br>|
| Other: usual care<br> | Procedure: Usual care<br>* Classical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain in the last 48 hours | Low back pain in the last 48 hours assessed on a numerical pain scale (0 - 100) at 4 months | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability (Quebec questionnaire) | Evaluation by quality of life questionnaries | 1 month and 4 months | 
| Anxiety and depression (HAD) | Evaluation by specific anxiety and depression questionnaries | 1 month and 4 months | 
| Quality of life (SF-12) | Evaluation by quality of life questionnaries | at 1 and 4 months | 
| Overall serum antioxidant defenses | Determination of AOPP and carbonyl compounds, markers of oxidative stress and the TAS (total antioxidant status) that assesses the overall serum antioxidant defenses | at inclusion (baseline) and 1 month after inclusion | 

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