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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Low back pain in the last 48 hours
Study Overview
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 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.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
virtual reality
Intervention: Virtual reality (Procedure)
usual care
Intervention: Usual care (Procedure)
Outcomes
Primary Outcomes
Low back pain in the last 48 hours
Time Frame: 4 months
Low back pain in the last 48 hours assessed on a numerical pain scale (0 - 100) at 4 months
Secondary Outcomes
- Quality of life (SF-12)(at 1 and 4 months)
- Disability (Quebec questionnaire)(1 month and 4 months)
- Anxiety and depression (HAD)(1 month and 4 months)
- Overall serum antioxidant defenses(at inclusion (baseline) and 1 month after inclusion)