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

Low Back Pain Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

• NCT number: NCT01407653
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Completion date: April 2015