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

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

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.

Study Overview

• Status: Completed
• Conditions: Allodynia
• Intervention / Treatment: Other: Standard Medical treatment; Device: Vibrotactile stimulation; Device: Sham Stimulation with Vibradol device switched off

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France
    • Paris, Île-de-France, France, 75015
      • CRRF La Chataigneraie Convention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: Standard Medical treatment; Standard treatment with drugs and usual rehabilitation; Device: Vibrotactile stimulation; Rehabilitation by vibrotactile stimulation at medical center
SHAM_COMPARATOR: 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	Other: Standard Medical treatment; Standard treatment with drugs and usual rehabilitation; Device: Sham Stimulation with Vibradol device switched off; Sham Rehabilitation at medical center but with Vibradol device switched off
OTHER: Standard Medical treatment; Observational group, treated as usually by medications and rehabilitation.	Other: Standard Medical treatment; Standard treatment with drugs and usual rehabilitation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CRRF La Châtaigneraie
• Collaborators: Hôpitaux Universitaires Paris Ile-de-Franc Ouest
• Investigators: Study Chair: Rania Belmahfoud, MD, CRRF La Chataigneraie Convention; Study Director: Valérie Zingale, CRRF La Chataigneraie Convention

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): May 2, 2019
• Study Completion (ACTUAL): May 2, 2019

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (ESTIMATE): October 8, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: static mechanical allodynia; somatosensory rehabilitation; vibrotactile stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Hyperalgesia
• Other Study ID Numbers: 14RBD-RESISTAL; 2014A013 08-39 (REGISTRY: N°IDRCB)