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

Allodynia Clinical Trial

— RESISTAL  

Official title:

Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571010
• Other study ID #: 14RBD-RESISTAL
• Secondary ID: 2014A013 08-39
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2, 2019

Study information

• Verified date: November 2020
• Source: CRRF La Châtaigneraie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allodynia
• Hyperalgesia

Intervention

Other:
• Standard Medical treatment
Standard treatment with drugs and usual rehabilitation

Device:
• 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

Locations

Country	Name	City	State
France	CRRF La Chataigneraie Convention	Paris	Île-de-France

Sponsors (2)

Lead Sponsor	Collaborator
CRRF La Châtaigneraie	Hôpitaux Universitaires Paris Ile-de-Franc Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Analgesics consumption	Amount of analgesic drugs	At 6 months
Secondary	Afterglow effect	An evaluation of static mechanical allodynia in surface and intensity at 6 months	At 6 months