NCT01407653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

May 30, 2011

Last Update Submit

November 17, 2025

Conditions

Low Back Pain

Keywords

Low back painvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Disability (Quebec questionnaire)

    1 month and 4 months

  • Anxiety and depression (HAD)

    1 month and 4 months

  • Quality of life (SF-12)

    at 1 and 4 months

  • Overall serum antioxidant defenses

    at inclusion (baseline) and 1 month after inclusion

Study Arms (2)

virtual reality

EXPERIMENTAL
Procedure: Virtual reality

usual care

OTHER
Procedure: Usual care

Interventions

Virtual realityPROCEDURE

3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks

virtual reality
Usual carePROCEDURE

Classical care

usual care

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • Sick leave over 1 year
  • Pregnant women
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Serge POIRAUDEAU, MD, PhD

    Cochin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2011

First Posted

August 2, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2014

Study Completion

April 1, 2015

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)