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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
CHARCOT MARIE TOOTH DISEASE	Device: TENS	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs
Study Start Date :	June 2012
Estimated Primary Completion Date :	August 2013
Estimated Study Completion Date :	August 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Visual Analogue Scale [ Time Frame: At 3 month ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Cécile RIBIERE, Dr	04 92 03 55 05	ribiere.c@chu-nice.fr

Locations

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

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator:	Cécile RIBIERE	CHU Nice

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT01918826 History of Changes
Other Study ID Numbers:	11-AOI-06
First Posted:	August 8, 2013
Last Update Posted:	August 8, 2013
Last Verified:	July 2012

Additional relevant MeSH terms:

Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Tooth Diseases; Intermittent Claudication; Stomatognathic Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases	Neuromuscular Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs