Evaluation of the Efficacy of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia
NCT ID: NCT02571010
Last Updated: 2020-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2015-10-31
2019-05-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vibrotactile stimulation
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
Standard Medical treatment
Standard treatment with drugs and usual rehabilitation
Vibrotactile stimulation
Rehabilitation by vibrotactile stimulation at medical center
Sham Stimulation with Vibradol device switched off
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
Standard Medical treatment
Standard treatment with drugs and usual rehabilitation
Sham Stimulation with Vibradol device switched off
Sham Rehabilitation at medical center but with Vibradol device switched off
Standard Medical treatment
Observational group, treated as usually by medications and rehabilitation.
Standard Medical treatment
Standard treatment with drugs and usual rehabilitation
Interventions
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Standard Medical treatment
Standard treatment with drugs and usual rehabilitation
Vibrotactile stimulation
Rehabilitation by vibrotactile stimulation at medical center
Sham Stimulation with Vibradol device switched off
Sham Rehabilitation at medical center but with Vibradol device switched off
Eligibility Criteria
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Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Hôpitaux Universitaires Paris Ile-de-Franc Ouest
OTHER
CRRF La Châtaigneraie
OTHER
Responsible Party
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Principal Investigators
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Rania Belmahfoud, MD
Role: STUDY_CHAIR
CRRF La Chataigneraie Convention
Valérie Zingale
Role: STUDY_DIRECTOR
CRRF La Chataigneraie Convention
Locations
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CRRF La Chataigneraie Convention
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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2014A013 08-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
14RBD-RESISTAL
Identifier Type: -
Identifier Source: org_study_id