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

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.

Eligibility Criteria

• Male or female patients aged ≥18 years;
• Static mechanical allodynia for less than 3 months, whatever its etiology and topography;
• Probable peripheral or central neuropathic pain or defined according to the IASP criteria;
• Neuropathic pain diagnostic questionnaire DN4 score ≥ 4/10;
• Chronic pain with average intensity ≥ 4/10;
• Analgesic treatment unchanged within 15 days prior to screening, and not planned to be modified during the study;
• Patient who can attend follow-up visits during the study;
• Patient affiliated to a health insurance plan or entitled;
• Patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.

Exclusion criteria

• Patient with neuralgia (spontaneous pain) with or without allodynia;
• Patient not able to participate actively to the rehabilitation exercises for physical reason, cognitive reason (ability to understand instructions) or behavioural reason (e.g. addiction...);
• Patient with complex regional pain syndrome (type I);
• Patients for whom cares cannot avoid any touch with allodynia area;
• Patient previously treated by a transcutaneous electrical nerve stimulation (TENS);
• Prior treatment by somatosensory rehabilitation;
• Duration of stay in the medical center < 11 weeks;
• Patient with cognitive disorder;
• Allodynia area of the patient presenting with conditions not recommended for vibrotactile stimulation: wound, unhealed nerve suture, recent skin transplantation, fragile organ such as eye.