Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs

June 15, 2026 updated by: Centre Hospitalier Universitaire de Nice

The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases: there is no curative treatment at present, on the other hand precautionary measures can be taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the literature and in our recent study (evaluation of the pain in the disease of CMT - Reference center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought back collateral effect, used at the same time in the chronic pain and acute since 1960, as well for the neuropathic pains that musculo-scrawny. No study was realized this day on the use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most frequent painful location in our recent works.

The main objective will be to analyze the improvement of the pain of lower limbs, based on the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.

The secondary objectives will be to estimate repercussions on the functional capacities ( ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and Depression scale).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • 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
      • Nice, France, 06000
        • CHU de NICE

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age included between 18 and 75 years
  • Affected by CMT confirmed on clinical, family criteria, electrophysiological and / or genetics
  • pain ≥ 3 months
  • EVA pain ≥ 4/10
  • patient having given his written consent and lit(enlightened)
  • patient susceptible to be followed regularly during at least 3 months
  • Patient member to the Social Security

Exclusion Criteria:

  • Expanding patients of associated neurological pathology
  • Patients having resorted to the TENS in the last 3 months
  • Medical history of cancers, collagen and quite other pathology which can interfere with the experimental procedure
  • Patient carrier of a pacemaker or an active implantable medical device
  • Cutaneous hurt on the territory to be stimulated
  • Venous or arterial thrombosis or thrombophlebitis in the territory to be stimulated
  • Patient participant in another biomedical research on the pain or the period of exclusion of which in a study is not ended
  • Patient under guardianship or deprived of all his liberties

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TENS active
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC ACTIVE
Device: TENS
Placebo Comparator: TENS placebo
NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC PLACEBO
Device: TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale
Time Frame: At 3 month
At 3 month

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Cécile RIBIERE, Centre Hospitalier Universitaire de Nice

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)

August 31, 2012

Primary Completion (Actual)

August 31, 2013

Study Completion (Actual)

July 31, 2014

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimated)

August 8, 2013

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-AOI-06

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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