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

Low Back Pain Clinical Trial

— REVLOC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407653
• Other study ID #: P100302
• Status: Completed
• Phase: N/A
• First received: May 30, 2011
• Last updated: September 28, 2016
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: September 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Intervention

Procedure:
• Virtual reality
3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks
• Usual care
Classical care

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	NEUROVIRTUAL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Disability (Quebec questionnaire)	Evaluation by quality of life questionnaries	1 month and 4 months	No
Secondary	Anxiety and depression (HAD)	Evaluation by specific anxiety and depression questionnaries	1 month and 4 months	No
Secondary	Quality of life (SF-12)	Evaluation by quality of life questionnaries	at 1 and 4 months	No
Secondary	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	No