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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Standard treatment with drugs and usual rehabilitation
Rehabilitation by vibrotactile stimulation at medical center
Sham Rehabilitation at medical center but with Vibradol device switched off
CRRF La Chataigneraie Convention
Paris, Île-de-France Region, France
Change of baseline in reduction of surface of allodynia area
Evaluate by the 15 g mono filament (Allodynographie) the reduction of surface of allodynia area
Time frame: At baseline, each week during the 10 week treatment period and at 6 months
Change of baseline in reduction of pain
Reduction of pain will be evaluated by QDSA questionnaire.
Time frame: At baseline, at each week, at 10 weeks and at 6 months
Change of baseline in reduction of allodynia intensity
Reduction of allodynia intensity will be measured with the method with the colors
Time frame: At baseline, at each week, at 10 weeks and at 6 months
Change of baseline of patient's satisfaction with regard to received care
Patient's satisfaction with regard to pain relief will be evaluated by VAS
Time frame: At baseline, at each week, at 10 weeks and at 6 months
Analgesics consumption
Amount of analgesic drugs
Time frame: At 6 months
Afterglow effect
An evaluation of static mechanical allodynia in surface and intensity at 6 months
Time frame: At 6 months
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