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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice Identifier:
First received: July 20, 2012
Last updated: August 7, 2013
Last verified: July 2012

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 Intervention
Device: TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Visual Analogue Scale [ Time Frame: At 3 month ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TENS active
Device: TENS
Placebo Comparator: TENS placebo
Device: TENS


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

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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Please refer to this study by its identifier: NCT01918826

Contact: Cécile RIBIERE, Dr 04 92 03 55 05

CHU de Nice Recruiting
Nice, France, 06000
Contact: Cécile RIBIERE, Dr    04 92 03 55 05   
Principal Investigator: Cécile RIBIERE, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Principal Investigator: Cécile RIBIERE CHU Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice Identifier: NCT01918826     History of Changes
Other Study ID Numbers: 11-AOI-06
Study First Received: July 20, 2012
Last Updated: August 7, 2013

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Tooth Diseases
Intermittent Claudication
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Stomatognathic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 25, 2017