NCT02571010

Evaluation of the Efficacy of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia

Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: CRRF La Châtaigneraie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.

Detailed description

This is a monocenter study. 45 patients will be enrolled in the study, allocated by randomization in 3 arms of 15 patients each. During the 38 week duration of the study, enrolled patients will be assessed at: * initial evaluation (first week of the study), * intermediary evaluation for every week and every modification of intensity of pain, * final evaluation at 10 weeks, * follow-up evaluation at 6 months.

Conditions

• Allodynia

Interventions

Type	Name	Description
OTHER	Standard Medical treatment	Standard treatment with drugs and usual rehabilitation
DEVICE	Vibrotactile stimulation	Rehabilitation by vibrotactile stimulation at medical center
DEVICE	Sham Stimulation with Vibradol device switched off	Sham Rehabilitation at medical center but with Vibradol device switched off

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-05-02
• Completion: 2019-05-02
• First posted: 2015-10-08
• Last updated: 2020-11-12

Locations

1 site across 1 country: France