Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Allodynia
- Sponsor
- CRRF La Châtaigneraie
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Change of baseline in reduction of surface of allodynia area
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Change of baseline in reduction of surface of allodynia area
Time Frame: At baseline, each week during the 10 week treatment period and at 6 months
Evaluate by the 15 g mono filament (Allodynographie) the reduction of surface of allodynia area
Secondary Outcomes
- Analgesics consumption(At 6 months)
- Afterglow effect(At 6 months)
- Change of baseline in reduction of pain(At baseline, at each week, at 10 weeks and at 6 months)
- Change of baseline in reduction of allodynia intensity(At baseline, at each week, at 10 weeks and at 6 months)
- Change of baseline of patient's satisfaction with regard to received care(At baseline, at each week, at 10 weeks and at 6 months)