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| Name | Class |
|---|---|
| NEUROVIRTUAL | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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:
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
Intervention protocol for patients randomized to Arm "virtual reality":
M1 - 1 Month Visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| virtual reality | Experimental |
| |
| usual care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Procedure | 3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disability (Quebec questionnaire) | Evaluation by quality of life questionnaries | 1 month and 4 months |
| Anxiety and depression (HAD) | Evaluation by specific anxiety and depression questionnaries |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge POIRAUDEAU, MD, PhD | Cochin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Usual care | Procedure | Classical care |
|
| 1 month and 4 months |
| Quality of life (SF-12) | Evaluation by quality of life questionnaries | at 1 and 4 months |
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |