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Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CRRF La Chataigneraie Convention
Paris, Île-de-France Region, France
Start Date
October 1, 2015
Primary Completion Date
May 2, 2019
Completion Date
May 2, 2019
Last Updated
November 12, 2020
17
ACTUAL participants
Standard Medical treatment
OTHER
Vibrotactile stimulation
DEVICE
Sham Stimulation with Vibradol device switched off
DEVICE
Lead Sponsor
CRRF La Châtaigneraie
Collaborators
Data Source & Attribution
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