Status:
COMPLETED
Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
NEUROVIRTUAL
URC-CIC Paris Descartes Necker Cochin
Conditions:
Low Back Pain
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01407653
Start Date
June 1 2011
End Date
April 1 2015
Last Update
November 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cochin Hospital
Paris, France, 75014