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

November 10, 2020 updated by: CRRF La Châtaigneraie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At baseline, each week during the 10 week treatment period and at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of baseline in reduction of pain
Time Frame: At baseline, at each week, at 10 weeks and at 6 months
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
Time Frame: 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
At baseline, at each week, at 10 weeks and at 6 months
Change of baseline of patient's satisfaction with regard to received care
Time Frame: 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
At baseline, at each week, at 10 weeks and at 6 months
Analgesics consumption
Time Frame: At 6 months
Amount of analgesic drugs
At 6 months
Afterglow effect
Time Frame: At 6 months
An evaluation of static mechanical allodynia in surface and intensity at 6 months
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CRRF La Châtaigneraie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hôpitaux Universitaires Paris Ile-de-Franc Ouest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rania Belmahfoud, MD, CRRF La Chataigneraie Convention
  • Study Director: Valérie Zingale, CRRF La Chataigneraie Convention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14RBD-RESISTAL
  • 2014A013 08-39 (REGISTRY: N°IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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