Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain
CompletedNot applicableNCT01407653
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Procedure: Virtual reality
- Procedure: Usual care
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Collaborators
- NEUROVIRTUAL; URC-CIC Paris Descartes Necker Cochin
- Start date
- 2011-06
- Primary completion
- 2014-11
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01407653