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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Allodynia

Intervention / Treatment
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* Other: Standard Medical treatment
* Device: Vibrotactile stimulation
* Device: Sham Stimulation with Vibradol device switched off


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrotactile stimulation<br>Patients in this arm will have treatment by medications and rehabilitation treatment by vibrotactile at medical center stimulation at home by soft tissue non stimulation on allodynia area | Other: Standard Medical treatment<br>* Standard treatment with drugs and usual rehabilitation<br>Device: Vibrotactile stimulation<br>* Rehabilitation by vibrotactile stimulation at medical center<br>|
| Sham Comparator: Sham Stimulation with Vibradol device switched off<br>Patients in this arm will have treatment by medications and rehabilitation Sham vibrotactile treatment at medical center but with Vibradol device switched off abdominal breath exercises at home non stimulation on allodynia area | Other: Standard Medical treatment<br>* Standard treatment with drugs and usual rehabilitation<br>Device: Sham Stimulation with Vibradol device switched off<br>* Sham Rehabilitation at medical center but with Vibradol device switched off<br>|
| Other: Standard Medical treatment<br>Observational group, treated as usually by medications and rehabilitation. | Other: Standard Medical treatment<br>* Standard treatment with drugs and usual rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At baseline, each week during the 10 week treatment period and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline in reduction of pain | Reduction of pain will be evaluated by QDSA questionnaire. | 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 | 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 | At baseline, at each week, at 10 weeks and at 6 months | 
| Analgesics consumption | Amount of analgesic drugs | At 6 months | 
| Afterglow effect | An evaluation of static mechanical allodynia in surface and intensity at 6 months | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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static mechanical allodynia, somatosensory rehabilitation, vibrotactile stimulation