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NCT04007302: NGUYEN
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
NA trial testing measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy) in Low Back Pain in 15 participants. Completed in 3 November 2018.
3 November 2018
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 9 September 2018 |
| Primary completion | 3 November 2018 |
| Estimated completion | 3 November 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)
- completion of questionnaires
- completion of questionnaires for pain
Conditions studied
- Low Back Pain — all drugs for Low Back Pain →
Sponsor
Centre Hospitalier Universitaire de Nīmes
Who can join
Adults 18 to 75, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The hypothesis of this work is that distraction is an effective way to modify the feeling and experience of chronic lumbar pain by modifying the functioning of the prefrontal cortex. The main objective of this study is to show that during chronic low back pain generated during physical exercise, virtual reality distraction leads to the modification of the activity of the prefrontal cortex. The secondary objectives are: * Show a significant decrease in the average pain assessed with EVA during physical exercise with virtual reality distraction. * Show an increase in the distance travelled with virtual reality distraction. * Observe a decrease in perceived effort with virtual reality distraction. * Quantify the adherence (presence) of subjects to the virtual environment
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04007302
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Centre Hospitalier Universitaire de Nīmes trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04007302 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes
- Last refreshed: 8 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04007302.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing