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

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: Unknown
• Conditions: CHARCOT MARIE TOOTH DISEASE
• Intervention / Treatment: Device: TENS

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • CHU de Nice
    • Contact: Cécile RIBIERE, Dr; Phone Number: 04 92 03 55 05; Email: ribiere.c@chu-nice.fr
    • Principal Investigator: Cécile RIBIERE, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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	At 3 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 8, 2013

Study Record Updates

• Last Update Posted (Estimate): August 8, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Stomatognathic Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Tooth Diseases; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy
• Other Study ID Numbers: 11-AOI-06