Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      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: 
      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
    

Intervention name(s): Virtual reality; Usual care
Intervention type(s): Procedure; Procedure
Intervention description(s): 3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks; Classical care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back pain; virtual reality