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

Not Applicable

Completed

• Conditions: Allodynia
• Interventions: Other: Standard Medical treatment; Device: Vibrotactile stimulation; Device: Sham Stimulation with Vibradol device switched off

• Registration Number: NCT02571010
• Lead Sponsor: CRRF La Châtaigneraie

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Primary Completion: 2019-05-02
• Study Completion: 2019-05-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibrotactile stimulation	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
Sham Stimulation with Vibradol device switched off	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
Vibrotactile stimulation	Standard Medical treatment	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
Sham Stimulation with Vibradol device switched off	Standard Medical treatment	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 Medical treatment	Observational group, treated as usually by medications and rehabilitation.

Primary Outcome Measures

Name	Time	Method
Change of baseline in reduction of surface of allodynia area	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 Outcome Measures

Name	Time	Method
Analgesics consumption	At 6 months	Amount of analgesic drugs
Afterglow effect	At 6 months	An evaluation of static mechanical allodynia in surface and intensity at 6 months
Change of baseline in reduction of pain	At baseline, at each week, at 10 weeks and at 6 months	Reduction of pain will be evaluated by QDSA questionnaire.
Change of baseline in reduction of allodynia intensity	At baseline, at each week, at 10 weeks and at 6 months	Reduction of allodynia intensity will be measured with the method with the colors
Change of baseline of patient's satisfaction with regard to received care	At baseline, at each week, at 10 weeks and at 6 months	Patient's satisfaction with regard to pain relief will be evaluated by VAS

Trial Locations

Locations (1)

CRRF La Chataigneraie Convention; 🇫🇷 Paris, Île-de-France, France