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

This study is currently recruiting participants.
Verified December 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Kort & Lonn Ingeniery Society
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01407653
First received: May 30, 2011
Last updated: January 2, 2014
Last verified: December 2013

May 30, 2011
January 2, 2014
June 2011
June 2014   (final data collection date for primary outcome measure)
Low back pain in the last 48 hours [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Low back pain in the last 48 hours assessed on a numerical pain scale (0 - 100) at 4 months
Same as current
Complete list of historical versions of study NCT01407653 on ClinicalTrials.gov Archive Site
  • Disability (Quebec questionnaire) [ Time Frame: 1 month and 4 months ] [ Designated as safety issue: No ]
    Evaluation by quality of life questionnaries
  • Anxiety and depression (HAD) [ Time Frame: 1 month and 4 months ] [ Designated as safety issue: No ]
    Evaluation by specific anxiety and depression questionnaries
  • Quality of life (SF-12) [ Time Frame: at 1 and 4 months ] [ Designated as safety issue: No ]
    Evaluation by quality of life questionnaries
  • Overall serum antioxidant defenses [ Time Frame: at inclusion (baseline) and 1 month after inclusion ] [ Designated as safety issue: No ]
    Determination of AOPP and carbonyl compounds, markers of oxidative stress and the TAS (total antioxidant status) that assesses the overall serum antioxidant defenses
Same as current
Not Provided
Not Provided
 
Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain
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

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Back Pain
  • Procedure: Virtual reality
    3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks
    Other Name: Virtual reality
  • Procedure: Usual care
    Classical care
    Other Name: Usual care
  • Experimental: virtual reality
    Intervention: Procedure: Virtual reality
  • usual care
    Intervention: Procedure: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
122
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Serge POIRAUDEAU, MD, PhD ++33 1 58 41 25 49 serge.poiraudeau@cch.aphp.fr
Contact: Laurence Lecomte, PhD +331 58 41 35 45 laurence.lecomte@cch.aphp.fr
France
 
NCT01407653
P100302
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Kort & Lonn Ingeniery Society
Principal Investigator: Serge POIRAUDEAU, MD, PhD Cochin Hospital
Assistance Publique - Hôpitaux de Paris
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP