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

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

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