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

This is an interventional treatment trial for Allodynia focused on measuring static mechanical allodynia, somatosensory rehabilitation, vibrotactile stimulation Read More

Eligibility Criteria

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

Exclusion Criteria:

1. Patient with neuralgia (spontaneous pain) with or without allodynia;
2. 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...);
3. Patient with complex regional pain syndrome (type I);
4. Patients for whom cares cannot avoid any touch with allodynia area;
5. Patient previously treated by a transcutaneous electrical nerve stimulation (TENS);
6. Prior treatment by somatosensory rehabilitation;
7. Duration of stay in the medical center < 11 weeks;
8. Patient with cognitive disorder;
9. 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.